Currently Funded Research Projects
Do You Really Expect Me to get MST Care in a VA Where Everyone is Male? Innovative Delivery of Evidence Based Psychotherapy to Women with Military Sexual Trauma
Veterans who experience military sexual trauma (MST) are at heightened risk of developing psychiatric difficulties such as post-traumatic stress disorder (PTSD). Although the Veterans Health Administration (VHA) has identified MST positive Veterans as a high priority population, this group of Veterans may under-utilize evidence-based interventions for PTSD such as Prolonged Exposure (PE). Likely reasons for this under-utilization include unique barriers to care faced by MST survivors such as avoidance of VA medical facilities due to their potential to cue distressing memories and symptoms. The current study includes a randomized controlled study design comparing treatment engagement and clinical and quality of life outcomes between two groups: Veterans receiving PE for PTSD-related MST via homebased telehealth (PE-HBT) and Veterans receiving PE for PTSD-related MST via standard service delivery (PE-SD). The intervention component of the study is complemented by a qualitative component (i.e., patient interviews) designed to better understand Veterans’ reactions, preferences, difficulties, and suggestions for the intervention, as well as to solicit feedback about this patient population’s service needs and preferences more broadly. All Veterans enrolled in the study (i.e. Veterans in both groups) will benefit from receiving a well supported intervention for PTSD, Prolonged Exposure (PE), to address their MST-related symptoms. As such, all Veterans have the potential to experience significant symptom reduction related to their military sexual trauma post-intervention (i.e., within 12 weeks). However, women assigned to receive PE via home-based telehealth will have the particular advantage of being able to receive services from their home, thereby circumventing some of the traditional access to care barriers faced by this clinical population. It is anticipated that this advantage will result in increased session attendance and compliance, which in turn will result in better clinical and quality of life outcomes due to increased ‘dosing’ of the intervention. Thus, it is predicted that Veterans in PE-HBT will evidence better treatment engagement and more significant symptom improvement relative to Veterans in PE-SD. Treatment gains include a reduction of PTSD and other psychiatric symptoms such depression, as well as more global improvements in quality of life and social/occupational functioning. If, as anticipated, women in PE-HBT evidence improved outcomes relative to women in PE-SD, the current study findings can be used to establish an innovative service delivery model that will circumvent traditional barriers to care in an underserved, yet high risk patient population. Regardless of study outcomes, the proposed project stands to fill significant gaps in the literature with regard to how to optimally engage and retain MST positive Veterans in VA mental healthcare. Additionally however, there is only one PTSD treatment outcome study focused exclusively on female Veterans and no extant studies testing home-based telehealth for sexual assault victims. Thus, the proposed project also stands to make a significant contribution to mental health service delivery models for female Veterans and sexual assault victims more broadly.
National Elder Mistreatment Study: 5 Year Followup of Victims and Matched Non-Victims
STATEMENT OF THE PROBLEM
The overall aim is to conduct a longitudinal follow-up of participants (mistreatment victims and matched nonvictims) identified in the first National Elder Mistreatment Study (NEMS) to compliment our original prevalence findings with findings on consequences of elder mistreatment and financial exploitation in terms of Criminal Justice System (CJS) participation and mental health, the latter of which appears to affect participation. To date, no nationally representative, epidemiologic data exist to determine factors that predict CJS participation following elder mistreatment, or whether ecological factors (community resources) or health/mental health outcomes of mistreatment (depression) influence participation.
Specific Aims are:
1. To re-assess participants from the NEMS to identify factors related to CJS participation.
2. To examine effects of, and relations between multiple vs. single forms of elder mistreatment (e.g., financial abuse vs. financial abuse + physical abuse), on CJS participation and mental health.
3. To compare mental health outcomes across types of mistreatment, and between those who have and have not experienced mistreatment.
4. To examine the interplay between mental health outcomes and CJS participation.
Participants will be approximately 342 mistreatment victims (50% of the original total) and 500 matched (age and gender) non-victims age 64 and older recruited from among the 5,777 original subjects of the NEMS, fluent in either English or Spanish, and not suffering from dementia.
RESEARCH DESIGN AND METHODS:
Follow-up longitudinal study using NEMS mistreatment victims and NEMS matched non-victims. Assessment via Computer Assisted Telephone Interviewing procedures identical to those employed in the first wave of the NEMS.
Descriptive prevalence estimates of new victimization will be outlined, followed by bi-variate risk protective factor analyses for new mistreatment, CJS participation, and mental health outcomes. Multivariate logistic regression and linear regression analyses will be employed to clarify risk relationships and the effects of mental health outcomes following victimization on CJS participation and outcomes.
PRODUCTS, REPORTS, AND DATA ARCHIVING
Expected products include an extensive elder mistreatment and outcomes data set, variable codebook, and survey instrument, detailed final reports, data-based presentations, and scholarly articles. In addition, a file containing computed variables will be delivered. These variables will also be labeled, and the labeling convention will include computational formulas. Moreover, the programming prose used to compute the variables (e.g., the syntax) will also be supplied
In-Home Exposure Therapy for Veterans with PTSD
Randomized Controlled Trial of Sertraline, Prolonged Exposure Therapy and Their Combination of OEF/OIF with PTSD
The current research study aims to compare the effectiveness of two proven treatments for posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their combination. In addition, the investigators are examining predictors of response to these two treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such treatments. In addition, the investigators will examine acceptability of each treatment and reasons for ending treatment.
Official title: Randomized Trial of Sertraline, Prolonged Exposure, and Their Combination for Post-traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF).
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Posttraumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)
Secondary outcome: Posttraumatic stress disorder (PTSD) related psychopathology, including depression, alcohol and substance abuse, and general anxiety
RWJF Future of Nursing
This proposal requests support for two RWJ Future of Nursing Scholars for the MUSC Online PhD in Nursing program. Our program strives to take nursing science to the highest level in a culture of innovation, collaboration and accountability. We define nurse scientists as nurses who plan to pursue a research interest with a program of externally funded research using rigorous, well-designed methods that address a gap in the care of vulnerable populations. We demonstrate the resources, experience, and innovation to successfully mentor a focused student through the 45 semester-hour online program in three years. This program is streamlined to focus on the essential competencies to the developing nurse scientist yet include diverse opportunities for mentored and elective work in policy, teaching, research, and leadership.
Our experience in mentoring students in a distance format is reflected in our ranking as #2 among online graduate programs in US News and World Report. Mentoring and academic support services delivered in an online format are time tested and ready. We will supply these RWJ scholars with a senior peer, a faculty advisor, comprehensive academic support course, a writing specialist and link them to our 2014 RWJ Scholar during the summer before classes even begin. The scholars will be mentored and taught by a faculty that reached 17th in NIH funding, with 75% (12/16) of the educator-research faculty funded as PI’s on federally funded grants. In the past five years, we have obtained 7 NIH R01 awards and additional NIH training and pilot awards. PhD students played a strong role in the research funding effort, with 5 of the 26 submitted proposals initiated by students. We have faculty with experience in mentoring post docs and participation in T-32s. About 80% of our PhD alumni are working as faculty and a majority are employed in research intensive environments. We benchmark our program success through the publications and funded grants of our current students and alumni.
The CON faculty is known for a range of funded work and populations that extends from population-based interventions to the physiological investigation of caring for chronic and acute illness. Our Office of Research highlights four stepwise mechanisms to help students with proposal development and implementation, and is supported by pre- and post-award support personnel and systems.
Our approach to diversity and inclusiveness is evidenced in our diverse student profile and high retention. We have 25 - 50% minority students any given year and an 89% rate of graduation. Our commitment to health equity, vulnerable populations, and diversity is reflected in every course. This same content is integrated into rich community based research opportunities with minority and vulnerable populations. CON faculty play key leadership roles in the NIH funded MUSC South Carolina Clinical and Translational Institute (SCTR). The South Carolina Clinical & Translation Research Center for Community Health Partnerships (SCTR/CCHP),dedicated to engaging community members and academic partners in all aspects of the research process to promote health, reduce the risk of illness and disease, and build community resilience to help transform health care and eliminate health disparities. Other intra-institutional research collaborations include the Center for Health Disparities Research, Hollings Cancer Center, College of Medicine, College of Dental Medicine, and College of Health Professions, and the VA. The RWJ scholar will participate and observe the working mechanism of these interdisciplinary SCTR cores, as well as assist in the academic products that result from them.
We are able to comply with all program requests and will meet the matching contribution required by the grant as detailed in the narrative.
Reducing Hospital Readmission Rates by Implementing an Inpatient Tobacco Cessation Service Driven by Interactive-Voice Recognition Technology
There is good reason to believe that providing tobacco cessation services to patients while hospitalized can improve clinical outcomes for patients. Smoking increases a patient’s risk for a host of negative clinical outcomes, including treatment-related toxicities and complications, medication side effects, and reduced performance status. Intervening with patients while hospitalized offers several advantages. First, patients are not permitted to smoke while in the hospital and temporary smoking abstinence may serve as a catalyst to help them remain tobacco free after discharge. Second, the illness that brought patients to the hospital may serve to motivate them to refrain from smoking. Third, hospitalized smokers have access to medical professionals and medications to assist in refraining from smoking. Thus, the Joint Commission (JC) has recommended that hospitals screen all patients for tobacco use and offer cessation services and follow up support within 1 month of discharge. Unfortunately, few hospitals implement the JC tobacco treatment standards in part because the services require extra costs, the standards are voluntary, and the financial benefits to hospitals and insurers have yet to be documented. In the future, national health policy changes may incentivize hospitals and insurers to explore how smoking cessation services may help to control healthcare costs. For example, the Centers for Medicare and Medicaid will penalize hospitals whose 30-day readmission rates exceed allowable limits for 5 conditions: 1) acute MI, 2) heart failure, 3) pneumonia, 4) COPD and 5) hip/knee replacement). The Medical University of South Carolina recently implemented an automated in-hospital smoking cessation program using IVR technology to follow-up with patients post-discharge in accordance with JC standards. This study takes advantage of in-place data capture mechanisms that allow efficient linkage between hospital clinical system, cessation program and statewide healthcare utilization datasets to examine hospital readmission and cost outcomes. The proposed study will use an interrupted time series design to examine monthly trends in readmission rates before (01/01/13-12/31/13) and after (02/01/14-01/31/15) program implementation, allowing us to test the hypothesis that an automated inpatient smoking cessation program will reduce unplanned readmissions and healthcare costs. This study provides an efficient way to examine whether investing in tobacco cessation services can help hospitals to avoid readmission penalties and reduce healthcare costs via secondary data analyses.
Sponsor/Type: American Heart Association (AHA)
The long-term goal of this project is to make significant contributions to the evolving healthcare model of predictive, medicine, especially in relation to eradication of ethnicity-based health disparities in essential hypertension and cardiovascular diseases (CVD). AIM 1 of this study will use a Machine-Learning Multivariate Adaptive Regression Splines approach with Jackson Heart Study archival data (with subsample cross validation) to expand an Endothelial System/Autonomic Nervous System pathway within a biobehavioral model and include additional (Sympathetic Nervous System, Endothelial System genes and environmental stressors) and Hypertension/CVD outcomes. AIM 2 will systematically examine additional Hypertension pathways (e.g. Epithelial Sodium channel/Renin-Aldosterone-Angiotension-System, Hypothalamic-Pituitary-Adrenal axis) using Multivariate Adaptive Regression Splines to detect gene by environment interactions and psychosocial characteristics related to Hypertension/CVD among the Jackson Heart Study population. Generalized Estimating Equations based on the Machine-Learning results will be calculated with results reviewed by an epidemiological expert that has over 25 years of experience in Hypertension studies to ensure appropriate inclusion of variable selection. The results will be used to determine effect-size for potential environmental exposure/pharmacogenetic intervention strategies for future trials.
Sponsor/Type: NIH/NINR - R21
Monitoring and managing newly healed chronic leg and foot ulcer skin temperature: a cooling intervention (MUSTCOOL) to prevent ulcer recurrence
The goal of this randomized control trial is to test a patient directed self-monitoring and self-management intervention aimed at preventing the recurrence of chronic venous leg and diabetic foot ulcers using skin temperature and cryotherapy (cooling). We propose MUSTCOOL, a novel ulcer prevention strategy for patients at highest risk for developing chronic ulcers; those with a previous history. We aim to compare a cooling treatment to a placebo to determine the outcomes on ulcer recurrence, pain, physical activity and quality of life.
Individuals with newly healed chronic ulcers will be invited to participate in MUSTCOOL’s two component intervention: 1) self monitoring skin temperature over targeted “hot spots” daily with an infrared thermometer; and 2) maintenance cooling with a cooling pack (or placebo pack) placed over the “hot spot” three times each week for 30 minutes. If the temperature of the “hot spot” becomes elevated 2°F above baseline (average of 30 days of daily temperature readings) for 2 days in a row, a bolus regimen of 5 consecutive daily, 30 minute applications of the cooling or placebo pack will be implemented. We will monitor safety and side effects, however, there have been no reported adverse events reported in our previous cryotherapy studies.
We designed this chronic ulcer prevention intervention that targets the remodeling phase, the final repair process of healing after chronic ulcer closure. The skin environment is particularly vulnerable to ulcer recurrence due to a persistent aberrant inflammatory state. Our previous research has demonstrated that cooling this skin reduces the abnormal metabolic activity, protecting it against ulcer recurrence. Recent advancements in infrared technology allow us to take images of the affect skin to identify the area that has the highest temperature or vulnerable “hot spot”. These “hot spots” will be self monitored by patients with newly healed ulcers in the home with an infrared thermometer that date and time stamps each reading. The study’s outcomes on physical activity will be evaluated with an accelerometer. We hypothesize that by improving the skin environment and reducing pain, patients will more likely be physically active and have better quality of life, all measurable goals for this study.
We will evaluate this prevention strategy over six months in 180 patients, 90 of whom will be randomized to receive the cooling pack and 90 the placebo. Our goal is to test this non-pharmacological, non-invasive clinical intervention as a tailored self-management strategy to prevent chronic ulcer recurrence. It will also determine alleviation of symptoms such as pain, and the debilitating effects on physical activity and quality of life.
Novel Wound Powder RGN107 to Reduce Wound Odor, Pain and Exudate at End-of-Life
Palliative care can provide comfort and support for individuals at the end of life who have a wound. Such people frequently face distressing symptoms that profoundly affect quality of life. Wound care research on feasible comfort measures is minimal to address physical symptoms such as pain, odor, and wound drainage (exudate) that often accompany wounds that develop at the end of life. We propose to study a wound comfort intervention comprised of a low-cost wound powder, RGN107 that can be sprinkled on wounds using a squirt bottle. After several applications, the powder forms a “crust” seal border over the wound, protecting it from dressings that can stick to the fragile wound bed and preventing manipulation from wiping, both of which can cause pain. The goal is to augment usual wound care, adding to the comfort and quality of life of dying individuals as well as their caregivers. No previous studies have determined the feasibility of using a specially developed wound powder to examine adherence to a wound comfort protocol for individuals receiving hospice care. Our pilot data indicate that RGN107 is nontoxic, and efficacious, providing substantial relief from pain and exudate from venous leg ulcers. We propose to extend these findings to a highly challenging population of hospice enrollees with wounds such as pressure ulcers. Approximately 50% of the individuals who develop wounds have tried various methods to manage symptoms, but continue to suffer from uncontrolled wound pain, odor, and exudate. The purpose of our study is to examine the feasibility of an enhanced wound care approach and examine monitoring of adherence, measures of signals of efficacy in the control of symptoms, and impact on quality of life after use of RGN107. This R21 will employ a comparative group design to determine feasibility in two models of a hospice organization, home based care and inpatient hospice that will target 50 individuals with life expectancies more than 1 month, but less than 6 months. We will tailor the training for each model recognizing the variability of caregivers. In the inpatient setting, training will be delivered over the three shifts and over several days. In the home, the registered nurses that plan wound care, along with associated agency and family caregivers will be instructed in the home setting over several training sessions. A DVD of wound procedures will be used to reinforce learning. Our team will monitor adherence by fidelity processes such as making regular visits to assess caregiver performance, evaluating the wound itself, and reviewing documentation. Data collection sources include project records, patient/provider logs, surveys and interviews conducted at three time points, baseline, and then weeks 2 and 4. We hypothesize our intervention will enhance comfort care and quality of life at the end of life for both the patient and the caregiver.
Open Label Pharmacokinetic Study of Granexin® Gel in Patients With Venous Leg Ulcers
The purpose of this study is to examine the concentration of the Granexin® that enters the body after application of the study drug to human subject’s VLUs. This type of testing is called pharmacokinetics (PK) and measures the amount of study drug in your blood and tells the researchers how much time it takes for the study drug to be absorbed into your body and how long it stays in your body, if any has been absorbed.
Preventing Venous Leg Ulcers with Cryotherapy: A Randomized Clinical Trial
Our R21 (NINR—1R21NR010604-01) Cryotherapy for Venous Disorders: A Pilot, demonstrated that cooling inflamed skin affected by venous disorders significantly reduced blood flow after a four-week intense cryotherapy intervention. This new trial will assess the efficacy of this home-based cryotherapy intervention by adding sequenced tapered cooling after a 30-day intense cooling period. The goal is to reduce skin blood flow of chronically inflamed skin, decrease the incidence of venous leg ulcers and pain, and improve quality of life. A myriad of surgical, pharmacologic, and non-pharmacologic therapies such as compression bandages are often tried, many with limited success. More than 70% of patients with venous disorders such as insufficiency develop edema, skin damage, and ulcers. Ulcer prevention is warranted because of the significant socioeconomic implications in terms of lost workdays and wages, decreased productivity and increased health care costs. Clinicians focus on the multiple treatment approaches, often without consideration of how patients can contribute to their own self-care. Our 9-month intervention is based on principles of heat transfer and cryotherapy theories involving microcirculation. With input from a cryotherapy expert and participants who completed the R21 pilot, we propose a sequenced intervention strategy, where cooling will be dosed daily for 30 minutes for the first month, and then decreased to twice weekly dosing in months 2–3, once weekly in months 4–6, then prn in months 7–9. We will measure blood flow, skin temperature, pain, quality of life, and the incidence of leg ulcers after months 1, 3, 6 and 9. Eligible participants will be randomized to treatment (low compression cooling wrap) or usual care (low compression non-cooling “sham” wrap). Participants in both groups will receive all study related materials including standardized instruction, skin thermometer, specially designed low compression wraps, leg elevator pillow, and compression stockings, and during an in-depth orientation session. We hypothesize that cryotherapy will enhance the largely ineffective non-pharmacologic self-care usual care model, that is, telling patients to wear compression stockings, elevate the legs, and get more exercise. These strategies are generally inadequate in achieving sustained change. Among our research methods we include rigorous process, impact and outcome monitoring. In an era of expectation for technological and pharmaceutical “fixes”, this self-care strategy, if efficacious, could be an economical way to decrease morbidity and pain for thousands of patients, frequently viewed as non-responsive to self care. Prevention of ulcers is also a major potential source of saved medical dollars. This trial is significant due to the burden of venous disorders, the complex physical characteristics of the population including excessive obesity and co-morbidity and the need to reach patients with a feasible, motivational, and supportive strategy to promote self-care. The objective is to establish a new practice standard for prevention.
Community-based Intervention under Nurse Guidance after Stroke (CINGS)
Stroke is the leading cause of severe disability in Americans, and African Americans (AA) are at the highest risk for stroke with rates approximately twice those of Whites. Also concerning, stroke in AA occur at younger age, and with higher severity than whites. Despite being affected at younger ages, AAs are less likely than whites to return to equivalent functional status and are more likely to die following stroke. This disparity cannot be explained by access to acute care or rehabilitation, but may relate to other personal, familial, and community factors that remain understudied. Because diabetes and hypertension are more prevalent among AA relative to Whites, and because both are significant risk factors for stroke, complex factors underlying these chronic diseases very likely also contribute to increased rate and relatively poor outcome of stroke found in AA. To address these complex issues, an innovative, coordinated approach is required that considers patient, family, and community level factors, both to explain disparate stroke recovery rates and to design and implement efficacious interventions for post stroke recovery in community residing AA patients. We have designed and successfully implemented precisely such an approach with Diabetes Belt communities and propose to do so for Stroke Belt communities as well through the Community-based Intervention under Nurse Guidance after Stroke (CINGS), a 12 week, nurse-coordinated, community health worker-delivered home-based intervention. Therefore, we propose to (1) Identify primary barriers and facilitators of post-stroke recovery for AA in the US Stroke Belt Buckle of SC through formative qualitative research (i.e., interviews, focus groups) with AA patients with stroke, their families, community leaders, and public health practitioners. (2) Develop CINGS intervention components to improve AA stroke recovery and community participation in stroke recovery activities by integrating evidence-based guidelines and AA community generated evidence to address factors that perpetuate disparity in stroke recovery. And (3) Subject CINGS to a pilot RCT with approximately 60 patients obtain variability estimates, measure preliminary effects, and explore potential relationships with mediators/moderators. We hypothesize that the intervention group will significantly improve along impact and outcome measures of interest as compared with the usual care group.
Novel Intervention Linking Public Housing with Primary Care to Prevent Diabetes
African American (AA) women are 80% more likely to be obese than their non-Hispanic, white counterparts. AA women are also at disproportionate risk for negative obesity-related health outcomes, including type 2 diabetes, hypertension, dyslipidemia, heart disease, and cancer. Further, AA women living in racially segregated, impoverished inner city neighborhoods are at even higher risk for obesity and associated sequalae, a set of problems exacerbated by the fact that they lack access to primary care and community related resources. To address barriers to primary care among these high-risk groups, Federally Qualified Health Center (FQHC) Primary Care Networks were formed, and now offer services to low SES patients who would otherwise go without care. However, DPP adaptation to this type of setting (that is, exporting DPP interventions to public housing) has not been thoroughly evaluated. Thus, there is a prime opportunity to examine whether novel partnerships linking FQHC networks with Public Housing infrastructure to deliver modified DPP programs directly into high risk communities are effective in reducing obesity and diabetes risk.
The goal of this R34 two-year planning project is to develop, implement, and evaluate a pilot multi-level DPP intervention. In this pilot study, we will use a randomized wait list control design to allocate 60 participants to pilot test a translational community based DPP intervention or FHCN/FQHC usual care. The specific aims are to: 1) Evaluate the feasibility, acceptability and implementation of the SHAPE UP intervention in Public Housing settings in the context of FHCN/FQHC infrastructure, using RE-AIM process and outcome indicators. 2) Conduct a preliminary evaluation of this intervention's effectiveness including weight loss at 24 weeks (primary outcome), secondary impact physiological measures (e.g., glucose, A1C, BP, lipids) and behavioral measures (e.g., physical activity (PA), nutrition) in intervention vs. control arms to estimate variability of measures for subsequent sample size calculation.
This highly significant and novel study by an experienced team with an extensive partnership history will provide preliminary data to inform an adequately powered, larger randomized controlled trial
Personalized Bio-Behavioral Weight Loss Intervention for African American Women
This K01 Mentored Research Scientist Development Award proposal is designed to provide the scholarly training, mentorship, and resources necessary for the candidate to develop expertise in bio-behavioral research. The candidate’s primary career goal is to become a funded independent investigator and recognized leader in the field of obesity prevention/treatment with expertise in developing personalized bio-behavioral weight loss interventions for African American (AA) women. To achieve this goal, a focused career development plan is proposed to:
1) Obtain knowledge and skills in understanding how genetic variants may be related to adiposity; modulate influence of lifestyle behaviors (i.e.PA, diet) upon changes in adiposity, and how these genotypes may eventually be used to help personalize behavioral interventions for obese AA women;
2) Obtain knowledge and skills in complex quantitative research methods, including bio-behavioral research designs and analyses, and advanced intervention development; and,
3) Enhance grant and scholarly writing skills, and manuscript production while continuing to build interdisciplinary collaborations with other researchers in the field of genetics, obesity and prevention research.
The Medical University of South Carolina provides a comprehensive training environment that includes senior scientists with expertise in bio-behavioral interventions, genetics, and health disparities research. The candidate has a strong interprofessional and inter-institutional mentoring team with complementary expertise in the development of community based randomized controlled trials (RCT), genetics, obesity prevention and treatment, bio-behavioral interventions, biostatistics and epidemiology.
The research plan, which builds on the training objectives, is directly responsive to the National Institute of Nursing Research’s (NINR) mission of integrating the biological and behavioral sciences, employing new technologies to research questions, improving research methods, and developing the scientists of the future. The broad goal of this research is to identify key components for development of efficacious socio-culturally tailored behavioral interventions for long-term weight loss in low socioeconomic status (SES) obese AA women. The socio-cultural preferences will be incorporated into behavioral change strategies, the communication of genetic information, and the adaptation of the format and delivery of the evidence-based Diabetes Prevention Program materials and approaches to promote weight loss. To meet this goal, the candidate will conduct an exploratory study using genetic database secondary data analyses. Secondly, an intervention development phase, with 80 obese AA women living in public housing neighborhoods in the Charleston, SC region, to integrate new knowledge and skills from genetics while advancing skills in bio-behavioral research intervention development and methodology. The results of the proposed preliminary studies will inform a larger, adequately powered and resourced community based RCT for obese AA women, that incorporates the use of genetic information and socio-cultural preferences to prescribe tailored weight loss strategies and promote long-term weight loss outcomes.
Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants
Compelling evidence exists that breast milk helps protect very low birthweight (VLBW; birthweight <1500 g) infants from prematurity-specific morbidities, including feeding intolerance, late onset sepsis, and necrotizing enterocolitis. Unfortunately, mothers of VLBW infants often exhibit delayed lactogenesis stage II (when the milk "comes in") and inadequate breast milk production. Several small observational studies have linked earlier initiation of breast milk expression following delivery with greater milk production. However, no research has conclusively determined the optimal timing of breast milk expression to increase milk production or decrease timing of lactogenesis stage II. Without this evidence, practice guidelines cannot be developed to guide mothers who want to provide breast milk to their VLBW infants, and these mothers will continue to struggle with inadequate milk production for infant consumption. The overall objective of this 3-year study is to identify a strategy for enhancing breast milk production in mothers of VLBW infants to increase consumption of breast milk by their premature VLBW infants. The proposed study will follow a prospective cohort (N = 189) of racially and economically diverse mothers of VLBW infants for 6 weeks following delivery to test 1 primary hypothesis and 2 exploratory hypotheses. The primary hypotheses are related to the following: Earlier initiation of breast milk expression following delivery is associated with (1) earlier lactogenesis stage II, and (2) greater volume of breast mil production during the first 6 weeks. Exploratory hypothesis I is related to the following: Earlier initiation of breast milk expression is associated with a greater percentage of breast milk consumed by the infant during hospitalization and at discharge. Exploratory hypotheses 2 is as follows: Earlier initiation of breast milk expression following delivery is associated with a greater volume of milk production during the first 6 weeks in infants born at 23-27 weeks gestation and those born at 28-32 weeks gestation. Following stratification according to the infant's gestational age, eligible women will be randomly assigned to one of three groups and instructed to start mechanically expressing their breasts, either in the first hour, 1-3 hours, or 3-6 hours following delivery. Timing of lactogenesis stage II will be documented, and volume of breast milk produced will be measured for the first 6 weeks. The percentage of breast milk the infant consumes weekly and at discharge will be measured. Results are expected to fill an important gap in research regarding the impact of timing of initiation of milk expression on milk volume, and timing of lactogenesis stage II in mothers of VLBW infants and the amount of breast milk their infant receives during hospitalization and at discharge. Results are also expected to provide new evidence regarding the impact of earlier initiation of milk expression in mothers delivering infants at differing gestational ages.
A Peer-Education Approach to Support the Behavioral Health Needs of Fire Service Professionals
Bounce Back Now: A Low-Cost Intervention to Facilitate Post-Disaster Recovery
Implementation of Prolonged Exposure in the Army: Is Consultation Necessary for Effective Dissemination?
We will develop, internally test, and deliver mobile web training materials to the lead investigators for this project (Drs. Foa and McLean). Dr. Foa and colleagues are examining how we can successfully disseminate and implement EBTs for PTSD in the Army by comparing PE training models. The mobile web training materials developed our team will be tested in the final year in the study. The study leaders will examine whether this leads to:
1) Greater perceived ability to supervise effectively; and
2) Greater self-efficacy in supervising.
Technology-based Tools to Enhance Quality of Care in Mental Health Treatment
Considerable effort is being made in many states to implement evidence based interventions in community mental health service agencies. One big challenge to this goal is enabling providers to achieve an adequate level of fidelity to established treatment models. Provider fidelity is highly variable even among well-trained practitioners. This project will take an important step toward enhancing quality of care by capitalizing on recent advances in technology to improve the delivery of interventions in real-world community settings. The use of web-based applications optimized for use on mobile devices (e.g., iPad) represents a highly innovative approach to achieving this aim. Research is needed to inform these efforts and evaluate this approach. The current project aims to develop and establish the feasibility of eTF-CBT, a technology-based toolkit for Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) that is designed to enhance the quality, accessibility, and efficiency of treatment. The eTF-CBT toolkit will consist of web-based applications optimized for use on mobile devices (e.g., videos, interactive games, drawing applications) that are used in session with children and caregivers. These activities will be designed to enhance patient engagement and support providers’ delivery of each major component of the protocol with fidelity. Activities were selected based on data from a sample of national trainers in TF-CBT who identified treatment components for which barriers and challenges to providers are significant. After initial development, the eTF-CBT toolkit will undergo alpha and beta testing. The results of this testing will guide refinements to the eTF-CBT toolkit in preparation for more extensive evaluation. Next, we will conduct a feasibility trial in which we will recruit 10 local mental health providers who will be trained in the eTF-CBT resource and will participate in a feasibility RCT of 20 families assigned to TF-CBT vs. eTF-CBT. Youth aged 8-15 years with clinically significant symptoms of posttraumatic stress disorder will be recruited from community-based mental health clinics. Baseline, mid-treatment, and post-treatment assessments will be conducted by an independent evaluator blind to study condition. Sessions will be audiotaped for fidelity coding, and rated for fidelity by an independent rater blind to study hypotheses. The trial will provide data on the feasibility of eTF-CBT and will demonstrate the feasibility of recruitment, assessment, and evaluation procedures used in the RCT. These data will be valuable as we prepare for a large-scale RCT that examines the incremental efficacy and efficiency of technology-assisted treatment. Although this initial project identifies a single treatment protocol, results will have broad implications because TF-CBT features several components (e.g., graduated exposure, behavior management principles, psychoeducation, risk reduction) that are of high relevance to a wide range of patient populations. The potential for technology-based applications to reach mental health services agencies nationally is high due to low maintenance costs and high accessibility.
Addressing Mental Health Needs in SC by Primary Care Nurse Practitioners
The MUSC College of Nursing (CON) outcomes obtained because of BSBSSCF's 2012 grant funding are powerful, however, there is much more work to be done! Additional advanced competencies are needed by CON DNP graduates in the fluctuating health care environment in order to best serve South Carolina's (SC) future health needs. SC has significant challenges with chronic illnesses such as asthma, cancer, diabetes, and heart disease, as well as comorbid mental health conditions. There are no SC DNP programs preparing nurses for certification in mental health care in the primary care setting at this time. This proposed project would provide outcomes that meet the BCBSSCF focus areas through increasing the number of frontline health care professionals and supporting innovative approaches to knowledge and skills development. The project activities, timetable and outcomes will include:
Further growth in information technology and technology support to ensure relevancy in online programming, teaching and clinical supervision for students in collaboration in monthly meetings with CON IT staff. Outcome: curriculum map, program evaluation. Grant funding will enable the development and implementation of an innovative program that will educate critically needed primary care nurse practitioners in psychiatric-mental health care to meet the complex health care needs of South Carolina.
This application requested support for primary care nurse practitioner students enrolled in the Doctor of Nursing Practice (DNP/MSN) primary care nurse practitioner degree program of the Medical University of South Carolina (MUSC) College of Nursing (CON). The overall goal/purpose of this project is to produce primary care advance practice nurses for rural and underserved areas in South Carolina and the nation. The six key objectives are to: 1. Increase the supply of APRN’s in underserved areas; 2. Increase diversity among APRN admissions by 10%; 3. Support students who currently live or work in rural or underserved areas; 4. Maintain attrition below 5% for DNP/MSN students receiving AENT funding; 5. NP graduates will achieve a 90% pass rate on certification exams; and 6. Increase AENT funded student’s clinical experiences in rural, HPSA or MUA areas by 10%. The specialty focus areas for the post-baccalaureate DNP and MSN are adult-geriatric (A/GNP), family (FNP) and pediatric (PNP) primary care.
At the funding of this grant we had 161 DNP/MSN students enrolled in the program. As per the AENT CON protocol, in the first month of grant funding a call went out to students telling them about AENT funding. We designed a simple check box tool for applying. We then worked with financial aid to obtain student information. To apply, students had to be enrolled in the ANP/FNP/PNP program with full or part time status, have an identified financial need, and have a GPA 3.5 or better. All students were evaluated utilizing a rubric tool with a point system for criteria based on living or working in a rural or medically underserved area, coming from a disadvantaged background, member of an underrepresented racial, ethnic or gender group and military veterans. Students were ranked and the highest rankings were picked. We are tracking students from past years as well as this new group of AENT funded students in regards to academic success and progression (GPA); attrition, clinical sites and upon graduate for certification and employment in a rural or underserved area.
Since 2011, the program has graduated 22 students who received AENT funding. Of the data received, 100% of those students passed their certification and 85% are currently working in a rural, medically underserved, and/or health professional shortage area. This meets objective 1. Between 2012 and 2013 there was a 1.7% increase in diversity in APRN admissions, between 2013 and 2014 there was a 6.6% increase. So while diversity was increased overall, the 10% goal of objective 2 was not reached. In the first year of this grant project period we selected 16 students who qualified out of 24 who applied. 13 of the selected students were from disadvantaged backgrounds or were underrepresented minorities allowing us to meet objective 3.
All of these students had demonstrated financial needs. For objective 4 we have been decreasing attrition rates steadily since 2009 at the CON with our most recent attrition rate being 2.2% for the MSN/DNP programs. For the AENT funded students the attrition rate is 2%. We continue to meet objective 5, staying well above out 90% pass rate on certification exams goal. Lastly, we have been successful in placing 100% of our students in rural, HPSA, or MUA clinical sites, meeting objective 6. With AENT funded student graduation we will continue to achieve the milestones for this grant and demonstrate successful outcomes.
Nurse Faculty Loan Program
This application is a request for financial loan support for students enrolled in a Doctor of Philosophy in Nursing (PhD) degree program and the post-Master’s Doctorate of Nursing Practice Program (DNP) at the College of Nursing (CON), Medical University of South Carolina (MUSC) with a career goal to serve as nurse faculty upon graduation. The CON DNP program is fully accredited by the Commission of Collegiate Nursing Education (CCNE) through June 30, 2016, and all MUSC programs were reaccredited by the Southern Association of Colleges and Schools Commission on Colleges (SACs) through 2017.
The objectives for this program are as follows:
Increase the number of graduate doctoral students in the BSN-DNP, post MSN-DNP, BSN-PhD and MSN-PHD programs who are prepared to become qualified nurse faculty upon program completion by:
Processes and evaluation for the program will occur as follows:
Program completion, reports and post-graduation follow-up. Students will be followed at the end of each semester to ensure successful completion of the courses. Longitudinal data will include collection of teaching program level for each NFLP graduate completed by the coordinators for the DNP and PhD program at 6 months post-graduation and every year for four years. Bi-annual reports for HRSA will be completed and submitted, (January & July) as required, by the Associate Dean of Academics.
Advanced Nursing Education Expansion
This application requests support for primary care nurse practitioner students enrolled in the newly implemented Doctor of Nursing Practice (DNP/MSN) primary care nurse practitioner degree program of the Medical University of South Carolina (MUSC) College of Nursing. The DNP program was implemented in 2009 and addresses the most contemporary aspects of expert clinical practice and in-depth knowledge and experience in leadership, health systems design and evaluation, evidence-based practice, health policy, and applied research. The specialty focus areas for the post-baccalaureate DNP are adult, family and pediatric primary care.
The College of Nursing has a long history of producing primary care practitioners. Its first nurse practitioner (NP) program was begun in 1994 with funding from a HRSA education grant. The nurse practitioner program was expanded in 1996 to include adult and pediatric tracks. The College has graduated a total of 257 primary care nurse practitioners. Many of these graduates have remained in South Carolina and continue to work in underserved areas. Recently, the MUSC Office for Healthcare Workforce Analysis and Planning generated a report using 2008 South Carolina APRN license renewal data and found that 18% (224) of all APRNs in the state of SC (1,266) were educated at the MUSC. Students enrolled in the DNP/MSN program are predominantly residents of the state of South Carolina (78%), a largely rural or very rural state, with almost every county designated as partially or completely medically underserved.
In fall 2009, the first cohort of DNP/MSN students were admitted. The enrollment for the PNP/FNP/ANP tracks was 38, which included 24 DNP and 14 MSN exit students. Because of our focus on preparing doctorally prepared providers, we significantly increased the number of DNP students admitted in the second cohort. Thus, 77 DNP/MSN students, (68 DNP/9 MSN) have currently matriculated for fall 2010 admission. The College estimates that a total of 115 DNP/MSN students will be enrolled during the next academic year (92 DNP and 23 MSN exit).
The majority of MUSC graduate nursing students have multiple responsibilities and significant student loans from previous degrees. The ANEE stipends would provide financial assistance for students choosing to speed up their progression and complete the program full-time.
Ethno-Cultural Barriers to Health Literacy/Disease Management in AAs
Virtual Interprofessional (VIP) Education
This proposal addresses two essential needs: 1) the need to extend healthcare provider training focused on quality and safety to include more engaged interprofessional teamwork and relationships beyond biomedical tasks in simulations; and 2) the need to identify the process and practices of interprofessional communication competencies in student teams with virtual and real-time colleagues (Headrick et al., 2012; Shore, 2013). This is particularly challenging given the current constraints of clinical education, which is
bound by space, location and conflicting academic schedules.
The IPEC competencies state the need to communicate interprofessionally and use effective techniques. However, it is not clear in the literature what are exemplary evidence-based patterns of effective interprofessional communication. In the area of patient safety, O’Daniel & Rosenstein (2008) point out that although there are communication techniques that may minimize errors, research has not yet demonstrated how their application in areas of miscommunication and professional barriers affects patient safety outcomes in either simulation or real-time. Furthermore little research has been conducted examining how to change patterns of communication within the interprofessional health team, whether real or virtual. Specifically, the simulation literature focuses predominantly on tasks, roles, and medical content, rather than the processes of communication and how that ultimately affects patent and family outcomes.
Four of the MUSC health care colleges (nursing, medicine, pharmacy and health professions) share universal values and competencies related to health care quality and safety that could be greatly enriched by interprofessional collaboration. Yet providing these learning experiences continues to be constrained by several barriers, primarily logistical, such as off-campus clinical rotations, differing academic schedules, and varying levels of online learning programs among the colleges.
Virtual learning is a promising, creative and cost-effective solution to traditional barriers (Rondon et al., 2013). Total experiential immersion of sight and sound, created in a virtual world, is reported to lead to greater comprehension of course material, and is increasingly used in progressive nursing and medical schools around the world (Blue Ridge Academic Health Group, 2013). Similar to simulation, a virtual world, allows for experiences with life threatening or sentinel events that are impossible to plan in the real world, and additionally allows “anytime, anywhere” participation to facilitate learning negotiation and conflict resolution skills with virtual colleagues as well as virtual patients. The exciting part is that virtual learning takes simulation to a new level of mastery. This project proposes to use this innovative technology to develop an interprofessional learning module that would be embedded into the curriculum of the four health profession schools at MUSC.
The Virtual Interprofessional Learning (VIP Learning) project will develop a prototype that can be expanded in the future to other clinical issues and additional health professional groups. Our intent is to use this new technology to take interprofessional education to a new level of experiential learning using state -of the- art technology. Development of this learning prototype can address a key issue of working with students who are not co-located to learn from meaningful clinical exchanges. Potentially what we develop can be widely disseminated to students in a variety of health professional schools who are not only physically distant from one another but also not even within the same university. In this way, this proposal could herald truly unique and advanced interprofessional educational opportunities.
Enhancing Kidney Donation Through Live Organ Video Educated Donors (LOVED)
Chronic Kidney Disease is diagnosed in four times as many African Americans (AAs) as Whites and nearly twice as many AAs perish from the condition. Kidney transplantation offers the best outcomes for patients with End Stage Renal Disease (ESRD) but rates of procurement far outnumber cadaver organ availability, especially among AAs. A superior option is living donor kidney transplantation (LDKT). Since AAs comprise only 18.5% of LDKT recipients, innovative and culturally preferred strategies are needed to increase LDKT within the AA community. We hypothesize that a patient-centered, two tiered culturally sensitive education/motivation intervention targeting AA ESRD patients and potential donors (PDs) using mobile health (mHealth) technology will result in: 1) increased ESRD patients’ willingness to ask for donation; 2) increased number of PDs who complete medical evaluation; and, 3) increased number of LDKTs. We will leverage mHealth technology as the delivery mechanism to maximize large scale dissemination potential. Guided by behavioral change and technology acceptability theories, the Live Organ Video Educated Donor [LOVED] program will be developed to address two domains. LOVED I will be tailored for AA ESRD patients and navigated by an AA LDKT recipient. LOVED II will be tailored for potential LDKT donors and navigated by an AA LDKT donor. iPad program delivery will include testimonial audio/video clips, home-work assignments, videoconferencing, chat room sessions, and text/emails. The proposed mixed methods research utilizes qualitative and quantitative studies in a 3 phase process of development that will involve:
1) Development of LOVED I and II technical content and delivery formats guided by behavioral and technological theories using 9 focus groups (8 per group) of AA LDKT recipients/donors, ESRD LDKT eligible patients, PDs who failed to complete screening and transplant healthcare provider team.
2) Conduct 3 month LOVED I and II proof of concept studies (LOVED I = 24 LDKT eligible patients; LOVED II = 24 PDs who did not complete screening) to assess program acceptability, feasibility, changes in self efficacy and attitudes. Also assessed will be % ESRD patients who identify PDs, % PDs who complete screening, % LDKTs and participants’ perceptions of cultural competence of intervention including levels of trust, discrimination, shared decision making and literacy.
3) Conduct two 6 month 2-arm randomized control trials (LOVED I vs. standard of care, N=60; LOVED II vs. standard of care, N=80) to generate estimates needed for design of a large scale RCT.
Smartphone Med Adherence Stops Secondary Strokes (SMASSS)
Medication Nonadherence and ED Visits: Medication adherence is defined as extent to which the prescribed dose, frequency and timing of the regimen are followed. Medication nonadherence (MNA) is a pervasive problem across chronic diseases. On average, 50% of patients take their medications as prescribed. MNA is strongly associated with increased emergency department (ED) visits, hospitalizations, re-hospitalizations and premature death. Approximately 33 % of ED visits are attributed to MNA. Heaton et al (2013) recently examined predictors of 459,209 MNA based visits from a National Hospital Ambulatory Medical Care Survey database. The leading predictors were age (21-55 year olds), Medicaid payment coverage, and primary diagnoses of mental health disorders followed by type two diabetes and hypertension. Interestingly, MUSC ED data for the previous 12 months indicate leading ED diagnoses were behavioral health illness, diabetes and hypertension. A recent meta-analysis indicated that relative to patients with high medication adherence levels, risk of ED visits, hospitalizations, rehospitalizations and premature death among nonadherent patients was highest among those with essential hypertension (5.4 times >) compared to other chronic diseases. Programs are desperately needed to help chronic disease patients, particularly uncontrolled hypertensives (often with comorbidities) eliminate MNA, establish and sustain BP control (as well as control of other comorbidity related physical risk factors) and avoid ED visits and hospitalizations.
Viability of mHealth Technology: Cell phones are used by ~91% of US adults, irrespective of race/ethnicity, socioeconomic status or geographical location (rural/urban). As of 10/2013, ~63% of cell phone users in the US have smart phones. National market projections indicate within 2 to 2.25 years, virtually all cellphones will be smart phones. Our research (n>300) has shown that among lower socioeconomic status, often Medicare/Medicaid recipients in the tricounty region, ~55 %of Hispanics and 50% of African Americans have smart phones with internet access. TACHL has developed a mobile health (mHealth) iterative design based behavioral change theory guided patient and provider centered MNA treatment program for uncontrolled hypertensives who often have multiple disease comorbidities. Patients have been Hispanics and African-Americans often with Medicaid/Medicare coverage who use federally qualified health centers for primary care. Our 6 month feasibility clinical trial has revealed high levels of adherence, treatment satisfaction and most importantly sustained JNC7 specified BP control. Medication adherence using medication possession ratios and real time electronic monitoring reached desired criterion (>.95) within first month and was sustained in all mHealth patients. JNC7 BP control was reached by month one in 100% of Hispanics and 90% of AAs and sustained through the 6 month trial.
Technology Enabled Emergency Dept. Avoidance Program (TEEDAP): We propose to implement our multi-component mHealth patient self management program that is fully operational, HIPAA compliant, patient friendly, and readily utilized by providers. TEEDAP is a culturally sensitive mHealth self-management program designed for Hispanics and African American MNA uncontrolled hypertensives with or without other chronic disease comorbidities. The program applies synergistic constructs from behavioral and technology application theories. It has been developed, tested, refined, further tested and optimized by direct guidance from patients and healthcare providers. Critical to its success has been patient guided use of easy to use inexpensive Bluetoothed biofunction measurement devices and electronic medication reminder devices. These devices send encrypted data through smart phone/tablet relay in real time to the TACHL server. The data are processed and based upon provider directed summary needs related to standard care risk factor control criteria, automated reports are generated and delivered to them. Typically, practice sites have had their nurse coordinator receive the summary reports every week or bi-monthly. Summaries often include average medication adherence levels, number of biofunction readings and average levels, minimums and maximums .Some providers request % of values falling within standard care designated categories (e.g., for hypertension: stage 1 or 2 prehypertension, stage 1 or 2 hypertension). Patients receive personalized motivational and reinforcement feedback via numerous communication routes based upon their adherence to self monitoring and medication intake. The program will be optimized by having a NP case manager oversee its delivery and management including use of encrypted televideo consultation sessions with patients. CMS guidelines will be followed for reimbursement.
Smartphone Medication Adherence Stops Hypertension (SMASH) Among Hispanics
Uncontrolled essential hypertension (EH) is a major risk factor for stroke, renal failure and cardiovascular events. Hispanics have the highest rate of uncontrolled EH (BP ≥ 140/90 mmHg) in the U.S. Two primary responsible factors are patient medication non-adherence and clinician failure to intensify therapy in timely manners (i.e., therapeutic inertia). BP control programs are needed which can be sustained by EHs and readily disseminated by healthcare providers. There have been no randomized controlled trials (RCTs) evaluating theory driven culturally tailored mobile health technology applications among Hispanics with uncontrolled EH. In response to PA-12-023, the proposed R21 research proposal will test and refine the Smart phone Medication Adherence Stops Hypertension (SMASH) program. SMASH includes multi-level components: 1) automated reminders from an electronic medication tray; 2) tailored text message/voice mail motivational feedback and reinforcement based upon adherence to daily medication and BP monitoring; 3) automated
summary reports and direct alerts to providers and 4) booster program for SMASHers who show deterioration in BP control and/or medication adherence after the 3 month trial. The aims are as follows:
Aim 1a: Conduct 3 month 2 arm (SMASH vs. enhanced Standard Care [SC]) feasibility RCT with 6 month follow up in 60 uncontrolled EH 21-55 year old Hispanics. Primary feasibility outcomes are measures of recruitment and retention rates, intervention use and patient and provider satisfaction, and Aim 1b: Obtain estimates of variability of changes in primary outcomes of BP changes (i.e. % reaching JN7 designated BP control: resting BP <140/90 mmHg). Other BP measures include: % reaching 24‑hour BP control: < 130/80 mmHg) and absolute reductions in resting and 24-hour BP at 3, 6, 9 months. Secondary outcomes: patient adherence (med intake, BP self-monitoring), self-determination theory constructs of self-efficacy and intrinsic motivation (i.e., autonomous regulation) and provider adherence to JNC7 guidelines (timing of med changes).
Aim 2. Conduct focus groups after 6 month final follow-up with providers and staff (n=6-10) and random sample of SMASHers (n=16) to assess key user reactions including perceived cultural sensitivity, acceptability, usability, salience & sustainability facilitators/barriers.
Aim 3. Triangulate data from Aims 1 and 2 to further refine and optimize SMASH and prepare for a full-scale efficacy/effectiveness RCT (PA-12-022, R01).
Long-term objective is to develop practical, effective and sustainable mHealth primary and secondary prevention programs for EH and CVD. Dissemination of SMASH across ethnic/racial groups will help ameliorate the burden of CVD and associated health disparities.
Smartphone Delivered Meditation for BP Control among Prehypertensives
Stage 2 pre essential hypertension (preEH; 130-139/<90 mmHg) entails a 3-fold risk of developing EH and 2-fold risk of cardiovascular disease (CVD) events compared to those with optimal blood pressure (<120/80 mmHg). Prevention programs are needed which can be sustained by preEHs and readily disseminated by healthcare providers. Psychological stress is a risk factor for future EH and CVD. Stress reduction via meditation has shown promise in reducing blood pressure (BP) but adult studies have not determined optimal dosage level nor evaluated dosage adherence objectively. Multiple underlying biobehavioral mechanisms linking meditation with BP reduction also require additional scrutiny. The proposed research will address these issues by further developing and optimizing a smart phone breathing awareness meditation program (Tension Tamer:TT). Stage 2 preEH 21-50 year old African Americans and Whites balanced by geographical locale (urban vs. rural) and healthcare providers from 12 practice sites (6 urban/6 rural with 12,843 stage 2 preEHs) within the OQUIN practice based research network will be enrolled.
The 3 stage process of intervention development specified in PA-11-063 will involve:
1) Optimization of TT content and delivery formats guided by behavioral and technological theories using 6 focus groups of OQUIN healthcare providers and 6 focus groups with preEHs (8 preEHs per group);
2) 6 month TT proof of concept study (n=60 stage 2 preEHs) to establish dosage tolerability and impact upon resting and 24 hour SBP and biobehavioral mechanisms: worry, rumination, anxiety, hostility, mindfulness, sleep, physical activity, sympathetic nervous system (SNS) and hypothalamic pituitary adrenal axis (HPA) activity;
12 month 2-arm randomized control trial (RCT; TT vs enhanced standard of care smart phone health education program; total n=80) to generate estimates needed for design of a large scale RCT. This series of iterative studies, implemented and guided by healthcare providers and their preEH patients, will result in an intervention acceptable to multiple racial/ethnic groups in both urban and rural settings, feasible to conduct in clinical practice settings, effective in reducing SBP in a pilot RCT and ready for a large scale RCT.
Scholars in Residence Fellowship Program
The proposed research is a qualitative mixed-method study design to ultimately decrease of the burden of disease related to obesity in youth. Specific Aim 1 is to develop a focus group with adolescents to gain insight to the barriers and problem of obesity from their perceptive.I hypothesis adolescents will engage and give input to propose an intervention for obesity prevention. I intend to conduct 3 focus groups of male and female adolescents to learn the problem from their perspective, and assess knowledge and perception of healthy weight, diet, and exercise prior to conducting a randomized control trial in the same population. Females and males will be in separate groups. Knowledge will be measured using a reliable and validated assessment tool (to be determined). Upon developing an intervention model, a 4th focus group will be conducted to engage adolescents for final approval prior to implementation. The intervention will be refined based on input from adolescent engagement. Accomplishing this will inform the design of an obesity prevention intervention to be used in African American churches with adolescents.
Specific Aim 2 is to develop an innovative model to increase healthy eating habits and activity in adolescent using education, an activity and intake tracker. I hypothesis that adolescents in the intervention group will increase their vegetable, fruit, and water consumption, as well as activity level over a 12-week study period. Male and female adolescents will receive traditional education using a science-based curriculum (to be decided) on 2 topics: (1) Calories In/Health Eating and (2) Calories Out/Activity. Baseline anthropometric measures (height, weight, blood pressure) will also be obtained. Adolescents will then be randomized to a control or intervention group. Dietary intake and physical activity will be measured using an innovative validated activity tracker for 12 weeks. The control group will be encouraged to track diet and physical activity using a paper diary. A post study focus group will assess feedback from both groups experience, collect post study anthropometric measures, and post surveys. Adolescents in the control group will then be given an activity-‐tracking device (cross over trial). Clinical outcomes include the delivery of intervention with church-placed adolescents, and ability to measure study outcomes.
Teen Health Advocate Leadership Program Planning Grant
Charleston PASOs: Improving Access to Health Services in the Tricounty Hispanic Community