Veteran Peer Coaches Optimizing and Advancing Cardiac Health
- Conditions
- HypertensionCardiovascular Disease (CVD)HyperlipemiaObesity
- Interventions
- Other: Community-based peer health coach intervention
- Registration Number
- NCT02697422
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
The purpose of this study is to test if having a Veteran peer health coach will improve blood pressure control among Veterans with high blood pressure and at least one other Cardiovascular disease (CVD) risk factor. The intervention will deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk, including healthy diet, regular to moderate-intensity physical activity, and smoking cessation. Facilitators, barriers, and costs of the intervention will be determined.
- Detailed Description
The Vet-COACH study is a peer health coaching program to help reduce Cardiovascular disease (CVD) risk among Veterans. The goal of the study is to test the effectiveness of a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple CVD risk factors with a hybrid type 1 implementation study. The study will focus on Veterans with poorly controlled hypertension and at least one other CVD risk factor to target a high risk population.
The study will conduct a randomized controlled trial to enroll n=400 Veterans to compare a peer health coach intervention consisting of home visits, telephone support, and linkages to appropriate community-based and clinic resources compared to usual VHA primary care. The primary outcome is reduction in systolic blood pressure from baseline to follow-up at 1-year. Secondary outcomes include a reduction in Framingham Cardiovascular risk score, individual cardiovascular risks (tobacco use, lipids), health related quality of life, and health care use. The investigators will also assess the effects of the peer health coach intervention on intermediate outcomes including social support, patient activation, patient/provider communication and health behaviors (e.g. medication adherence, physical activity, nutrition, alcohol use, and stress management). The cost of the intervention will be assessed to inform feasibility for future studies, determine Veteran and staff satisfaction with the intervention, and identify barriers and facilitators to adoption.
Note, the intermediate outcomes were not prespecified in the protocol for evaluation and were not specified in the grant, protocol paper, or in our SAP as outcomes and were removed from results analysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 264
- Must be a Veteran
- Have > 1 visit to VA Puget Sound Health Care Center(Seattle or American Lake VA) primary care or women's clinic in the past year
- Poorly controlled hypertension (> 150/90 mmHg)
- At least one other CVD risk (including overweight or obesity, body mass index > 25 kg/m2, tobacco use, hyperlipidemia LDL-c > 130 mg/dL)
- Hospitalization in the past 3 months for cardiovascular-related conditions (IHD, Cerebral Vascular Accident [CVA], PVD)
- Severe illness that precludes lifestyle program, end-stage renal disease (ESRD) on dialysis
- Nursing home resident, homeless
- Severe cognitive impairment
- Receiving home-based primary care (including VA Home Tele-Health and patients who received palliative care or are enrolled in hospice care)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peer health coach intervention group Community-based peer health coach intervention Eligible participants will be randomly assigned to receive a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple cardiovascular disease (CVD) risk factors.
- Primary Outcome Measures
Name Time Method Change in Systolic Blood Pressure (SBP) Baseline to follow-up at 1 year Change in systolic blood pressure (SBP) from baseline to 12-months. Blood pressure readings were obtained using standard procedures with a blood pressure monitor to obtain a mean SBP score of 3 blood pressure measurements. An increased reduction in mean SBP indicates a better outcome.
- Secondary Outcome Measures
Name Time Method Number of Emergency Room (ER) Visits Baseline to follow-up at 1 year Health care emergency room (ER) utilization are measured using VA administrative data.
Framingham Cardiovascular Risk Score (FRS) Baseline to follow-up at 1 year Framingham Cardiovascular risk score (FRS) indicates/measures mean risk of a cardiovascular event in the next 10 years (CVD risk). A subscale range of a minimum score of 0% and maximum score of 30% were used to measure a reduction in FRS scores. FRS algorithms include age, total and high-density lipoprotein cholesterol, systolic blood pressure, treatment for hypertension, diabetes, and cigarette smoking. (Risk is considered low if the FRS is less than 10% (indicating a better outcome), moderate if it is between 10% -19%, and high if it is 20% or higher indicating a worse outcome).
Body Mass Index (BMI) Baseline to follow-up at 1 year Body Mass Index (BMI) are measured as an individual cardiovascular risk. Measurements will be initially recorded in height (feet/inches), and weight (pounds/ ounces, which will be converted to weight in kilograms and height in meters. BMI is calculated as kg/m\^2.
Low Density Lipoprotein Cholesterol (LDL-c). Baseline to follow-up at 1 year Low density lipoprotein cholesterol (LDL-c) is measured as mg/dL. Lipoprotein cholesterol will be assessed as an individual cardiovascular risk and is based laboratory data of blood tests from VA CPRS medical records (when taken within 6 months of baseline and/or 1 year follow up appointment). If no lab data exits within this timeframe, blood was drawn.
Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score Baseline to follow-up at 1 year 12-Item Short Form Health Survey (SF-12) Mental Component Summary: Summary scores for vitality, mental health, social functioning, and role-emotional. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning Scaling scores are assessed using published standardized scoring system procedures for the SF-12.
Number of Hospitalizations Baseline to follow-up at 1 year Health care hospitalization utilization are measured using VA administrative data.
Current Tobacco Use Current tobacco use measured at Baseline and Follow up at one year Current tobacco use was reported as a binary (YES/NO) outcome based on responses from the Behavioral Risk Factor Surveillance System (BRFSS) measured tobacco use. Current cigarette smoking status and tobacco use ("chewing tobacco, snuff or snus") and frequency of use were measured on a three point scale: "Every day" (worse outcome); "Some days", and "Not at all" (better outcome). Current tobacco use included individuals who reported having smoked at least 100 cigarettes in their entire life (Yes or No) and reported smoking cigarettes now ("Every day" or "Some days"). Differences in primary and secondary outcomes between intervention and control groups were calculated using logistic regression.
Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS) Baseline to follow-up at 1 year 12-Item Short Form Health Survey (SF-12) Physical Component Summary: Summary scores for general health, physical functioning, role-physical, and bodily pain. Scores range from a minimum score of 0 to a maximum score of 100, with higher scores indicating better physical and mental health functioning Scaling scores are assessed using published standardized scoring system for the SF-12.
Number of Outpatient Clinic/Primary Care Visits Baseline to follow-up at 1 year Outpatient clinic/primary care utilization are measured using VA administrative data.
Trial Locations
- Locations (1)
VA Puget Sound Health Care System Seattle Division, Seattle, WA
🇺🇸Seattle, Washington, United States