Vet-COACH: Veteran Peer Coaches Optimizing and Advancing Cardiac Health

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT02697422

Collaborator

(none)

264

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease (CVD) Hypertension Hyperlipemia Obesity	Other: Community-based peer health coach intervention	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

264 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel: Participants are assigned to one of two groups--the control or intervention group- in parallel for the duration of the study.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)

Masking Description:

N/A; No masking will occur in this clinical trial.

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 30, 2017

Actual Primary Completion Date :

Jan 6, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peer health coach intervention group 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 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
No Intervention: Control group 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.

Arm

Intervention/Treatment

Experimental: Peer health coach intervention group

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

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

No Intervention: Control group

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.

Outcome Measures

Primary Outcome Measures

Reduction in systolic blood pressure [Baseline to follow-up at 1 year]
Reduction in systolic blood pressure.

Secondary Outcome Measures

Reduction in Framingham Cardiovascular risk score [Baseline to follow-up at 1 year]
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.
Tobacco use [Baseline to follow-up at 1 year]
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.
Overall Health, 12-Item Short-Form Health Survey [Baseline to follow-up at 1 year]
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.
Number of outpatient clinic visits, ER visits and hospitalizations in the previous year [Baseline to follow-up at 1 year]
Health care utilization will be measured using VA administrative data, including number of outpatient and ER visits, hospitalizations during the previous year.
Body Mass Index (BMI) [Baseline to follow-up at 1 year]
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.
Low density lipoprotein cholesterol (LDL-c). [Baseline to follow-up at 1 year]
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.
Participant self-reported use of non-VA care services, High Risk Patient Survey [Baseline to follow-up at 1 year]
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.

Other Outcome Measures

Social Support [Baseline to follow-up at 1 year]
The 8-item Medical Outcomes Study (MOS) Social Support Survey Instrument will be used to measure self-perceived overall social support, including community support.
Patient Activation, Consumer Health Activation Index (CHAI) [Baseline to follow-up at 1 year]
The CHAI will be used to measure patient activation, including self-rated ability to take preventive actions, manage symptoms of medical problems, find and use appropriate medical care, and work with health care providers.
Consumer Assessment of Health Plans (CAHPS) Clinician & Group Survey and Reporting Kit (Four-Point Scale) [Baseline to follow-up at 1 year]
The CAHPS survey will be used to measure patient satisfaction and patient/provider communication with the participant's physician and health care team.
International Physical Activity Questionnaire (IPAQ), Short [Baseline to follow-up at 1 year]
The IPAQ will be used to measure exercise and physical activity, which will assess self-management health behaviors.
Self-reported medication non-adherence questions [Baseline to follow-up at 1 year]
Self-reported medication non-adherence questions from Voils, C.I et al. will be used to measure medication adherence, which will be used to assess self-management health behaviors.
Nutrition, "Starting the conversation brief dietary assessment and intervention scale" [Baseline to follow-up at 1 year]
The tool will be used to measure nutrition from eating, which will be used to assess self-management health behaviors.
Food Frequency Questionnaire (FFQ) [Baseline to follow-up at 1 year]
The Food Frequency Questionnaire (FFQ) will be used to measure nutrition as related to food frequency, which will be used to assess self-management health behaviors.
The AUDIT Alcohol Consumption questionnaire (AUDIT-C) [Baseline to follow-up at 1 year]
AUDIT-C questionnaire will measure alcohol use, which will be used to assess self-management health behaviors.
Overall Health, 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity [Baseline to follow-up at 1 year]
The 12-Item Short-Form Health Survey will be used to measure overall health, which will be used to assess self-management health behaviors.
Food security [Baseline to follow-up at 1 year]
Food security will be measured using the United States Department of Agriculture, Economic Research Service. U.S. Household Food Security Survey Module: Six- Item Short Form.
Provider Communication [Baseline to follow-up at 1 year]
The publication, "Outcome measures for health education and other health care interventions" by Lorig, Kate; Stewart, Anita; Ritter, Philip; Gonz lez, Virginia; et al. will be used to confidence in communication with providers.
Blood Pressure Self Management Behaviors [Baseline to follow-up at 1 year]
Self Management Behaviors to control blood pressure will be measured by questions taken from the Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2009
Neighborhood Utilization, The Chronic Illness Resources Survey [Baseline to follow-up at 1 year]
Utilization of neighborhood resources will be assessed using the Chronic Illness Resources Survey: Cross-validation and sensitivity to intervention.
Patient Mental Health, The PHQ-8: A New Depression Diagnostic and Severity Measure [Baseline to follow-up at 1 year]
Patient Mental Health will be measured using the PHQ-8: A New Depression Diagnostic and Severity Measure
Health Literacy [Baseline to follow-up at 1 year]
Health literacy will be measured using questions taken from the article, Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep; 36(8):588-94.
Caregiver Support [Baseline to follow-up at 1 year]
The Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire will measure caregiver support.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)