Veteran Peer Coaches Optimizing and Advancing Cardiac Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vet COACH (Veteran Peer Coaches Optimizing and Advancing Cardiac Health)

Conditions
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Cardiovascular Disease (CVD), Hypertension, Hyperlipemia, Obesity

Intervention / Treatment
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* Other: Community-based peer health coach intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel: Participants are assigned to one of two groups--the control or intervention group- in parallel for the duration of the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer health coach intervention group<br>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. | Other: Community-based peer health coach intervention<br>* The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).<br>* Other names: Vet-Coach intervention;|
| No Intervention: Control group<br>Participants who meet the same eligibility criteria as participants in the intervention group will be randomly assigned to receive no intervention. Participants will continue to receive their regular, usual primary care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in systolic blood pressure | Reduction in systolic blood pressure. | Baseline to follow-up at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Framingham Cardiovascular risk score | Reduction in Framingham Cardiovascular risk score (FRS), which has good predictive validity for Coronary Heart Disease events. FRS algorithms include age, total and high-density lipoprotein cholesterol, systolic blood pressure, treatment for hypertension, diabetes, and cigarette smoking. | Baseline to follow-up at 1 year | 
| Tobacco use | Tobacco use will be measured as an individual cardiovascular risk. Tobacco use will be calculated based on self-reported number of cigarettes smoked, and/or of use of chewing tobacco, snuff, or snus. Questions on tobacco use will be taken from the Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire. | Baseline to follow-up at 1 year | 
| Overall Health, 12-Item Short-Form Health Survey | Overall Health will be assessed using the 12-Item Short-Form Health Survey to measure health related quality of life, which includes a summary assessment of role limitations caused by physical health, physical functioning, mental health, and general health. | Baseline to follow-up at 1 year | 
| Number of outpatient clinic visits, ER visits and hospitalizations in the previous year | Health care utilization will be measured using VA administrative data, including number of outpatient and ER visits, hospitalizations during the previous year. | Baseline to follow-up at 1 year | 
| Body Mass Index (BMI) | Body Mass Index (BMI) will be 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 will be calculated as kg/m^2. | Baseline to follow-up at 1 year | 
| Low density lipoprotein cholesterol (LDL-c). | Low density lipoprotein cholesterol (LDL-c) will be measured as mg/dL. Lipoprotein cholesterol will be assessed as an individual cardiovascular risk, and will be 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 will be drawn by the study nurse. | Baseline to follow-up at 1 year | 
| Participant self-reported use of non-VA care services, High Risk Patient Survey | Health care utilization will be measured using the High Risk Patient Survey to collect self-reported use of non-VA care services, including outpatient and ER visits, hospitalizations, or pharmacy utilization. | Baseline to follow-up at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking (tobacco use), Peer health coach, Systolic blood pressure, Framingham Cardiovascular risk score, Lipid, Health related quality of life, Health care utilization, Medication adherence, Physical activity, Nutrition, Alcohol use, Stress management