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Completed

NCT Number: NCT02697422

Veteran Peer Coaches Optimizing and Advancing Cardiac Health

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.

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Key information

Conditions

Cardiovascular Disease (CVD) Alcohol Drinking Behavior Body Weight Cardiovascular Diseases Drinking Behavior Dyslipidemias Health Behavior Hyperlipemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Medication Adherence Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Smoking Tobacco Use Treatment Adherence and Compliance Vascular Diseases

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Community-based peer health coach intervention

Other

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).

Other names: Vet-Coach intervention

Primary outcomes

  1. Change in Systolic Blood Pressure (SBP)

    Time frame: 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 outcomes

  1. Framingham Cardiovascular Risk Score (FRS)

    Time frame: 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).

  2. Body Mass Index (BMI)

    Time frame: 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.

  3. Current Tobacco Use

    Time frame: 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.

  4. Low Density Lipoprotein Cholesterol (LDL-c).

    Time frame: 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.

  5. Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score

    Time frame: 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.

  6. Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS)

    Time frame: 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.

  7. Number of Hospitalizations

    Time frame: Baseline to follow-up at 1 year

    Health care hospitalization utilization are measured using VA administrative data.

  8. Number of Emergency Room (ER) Visits

    Time frame: Baseline to follow-up at 1 year

    Health care emergency room (ER) utilization are measured using VA administrative data.

  9. Number of Outpatient Clinic/Primary Care Visits

    Time frame: Baseline to follow-up at 1 year

    Outpatient clinic/primary care utilization are measured using VA administrative data.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: Vet-COACH

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Mar 3, 2016
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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