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

Vet COACH (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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Hyperlipemia; Cardiovascular Disease (CVD)
• Intervention / Treatment: Other: Community-based peer health coach intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 71 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure (SBP)	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.	Baseline to follow-up at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Framingham Cardiovascular Risk Score (FRS)	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).	Baseline to follow-up at 1 year
Body Mass Index (BMI)	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.	Baseline to follow-up at 1 year
Current Tobacco Use	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.	Current tobacco use measured at Baseline and Follow up at one year
Low Density Lipoprotein Cholesterol (LDL-c).	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.	Baseline to follow-up at 1 year
Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score	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.	Baseline to follow-up at 1 year
Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS)	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.	Baseline to follow-up at 1 year
Number of Hospitalizations	Health care hospitalization utilization are measured using VA administrative data.	Baseline to follow-up at 1 year
Number of Emergency Room (ER) Visits	Health care emergency room (ER) utilization are measured using VA administrative data.	Baseline to follow-up at 1 year
Number of Outpatient Clinic/Primary Care Visits	Outpatient clinic/primary care utilization are measured using VA administrative data.	Baseline to follow-up at 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Support	The 8-item Medical Outcomes Study (MOS) Social Support Survey Instrument will be used to measure self-perceived overall social support, including community support.	Baseline to follow-up at 1 year
Patient Activation, Consumer Health Activation Index (CHAI)	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.	Baseline to follow-up at 1 year
Consumer Assessment of Health Plans (CAHPS) Clinician & Group Survey and Reporting Kit (Four-Point Scale)	The CAHPS survey will be used to measure patient satisfaction and patient/provider communication with the participant's physician and health care team.	Baseline to follow-up at 1 year
International Physical Activity Questionnaire (IPAQ), Short	The IPAQ will be used to measure exercise and physical activity, which will assess self-management health behaviors.	Baseline to follow-up at 1 year
Self-reported medication non-adherence questions	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.	Baseline to follow-up at 1 year
Nutrition, "Starting the conversation brief dietary assessment and intervention scale"	The tool will be used to measure nutrition from eating, which will be used to assess self-management health behaviors.	Baseline to follow-up at 1 year
Food Frequency Questionnaire (FFQ)	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.	Baseline to follow-up at 1 year
The AUDIT Alcohol Consumption questionnaire (AUDIT-C)	AUDIT-C questionnaire will measure alcohol use, which will be used to assess self-management health behaviors.	Baseline to follow-up at 1 year
Overall Health, 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity	The 12-Item Short-Form Health Survey will be used to measure overall health, which will be used to assess self-management health behaviors.	Baseline to follow-up at 1 year
Food security	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.	Baseline to follow-up at 1 year
Provider Communication	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.	Baseline to follow-up at 1 year
Blood Pressure Self Management Behaviors	Self Management Behaviors to control blood pressure will be measured by questions taken from the Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2009	Baseline to follow-up at 1 year
Neighborhood Utilization, The Chronic Illness Resources Survey	Utilization of neighborhood resources will be assessed using the Chronic Illness Resources Survey: Cross-validation and sensitivity to intervention.	Baseline to follow-up at 1 year
Patient Mental Health, The PHQ-8: A New Depression Diagnostic and Severity Measure	Patient Mental Health will be measured using the PHQ-8: A New Depression Diagnostic and Severity Measure	Baseline to follow-up at 1 year
Health Literacy	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.	Baseline to follow-up at 1 year
Caregiver Support	The Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire will measure caregiver support.	Baseline to follow-up at 1 year

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Karin M. Nelson, MD MSHS, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Publications and helpful links

General Publications

• Nelson K, Fennell T, Gray KE, Williams JL, Lutton MC, Silverman J, Jain K, Augustine MR, Kopf W, Taylor L, Sayre G, Vanderwarker C. Veteran peer Coaches Optimizing and Advancing Cardiac Health (Vet-COACH); design and rationale for a randomized controlled trial of peer support among Veterans with poorly controlled hypertension and other CVD risks. Contemp Clin Trials. 2018 Oct;73:61-67. doi: 10.1016/j.cct.2018.08.011. Epub 2018 Aug 29.
• Nelson KM, Taylor L, Williams JL, Rao M, Gray KE, Kramer CB, Epler E, Fennell T. Effect of a Peer Health Coaching Intervention on Clinical Outcomes Among US Veterans With Cardiovascular Risks: The Vet-COACH Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317046. doi: 10.1001/jamanetworkopen.2023.17046.

Helpful Links

• published standardized scoring system for the SF-12

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2017
• Primary Completion (Actual): January 6, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: February 16, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimated): March 3, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Nutrition; Medication adherence; Physical activity; Systolic blood pressure; Lipid; Alcohol use; Health related quality of life; Stress management; Health care utilization; Smoking (tobacco use); Peer health coach; Framingham Cardiovascular risk score
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Cardiovascular Diseases; Hyperlipidemias
• Other Study ID Numbers: IIR 14-063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

We will adhere to all VA 1200.12 policies to protect individual privacy & confidentiality of data. Data will be made available outside VA in response to a properly prepared Freedom of Information Act request submitted & evaluated by the VA Puget Sound FOIA Officer, or as passed down to the facility.

A unique study ID will label all data records to allow validation of results, but prevent data from being linked to individuals. Records across data sets can be cross-referenced using the study ID to verify accuracy of publication results. Research publications will be made available to the public via the National Library of Medicine PubMed Central website within one year after publication date(s). A Limited Dataset will be created & shared pursuant a Data Use Agreement that appropriately limits use of the dataset & prohibits recipients from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No