Clinical trial NCT02697422: Veteran Peer Coaches Optimizing and Advancing Cardiac Health
Official title: Vet COACH (Veteran Peer Coaches Optimizing and Advancing Cardiac Health)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease (CVD)
Hypertension
Hyperlipemia
Obesity
Keywords: 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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-03-03
Enrollment: 264
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: Baseline to follow-up at 1 year
Secondary outcomes:
measure: Framingham Cardiovascular Risk Score (FRS)
timeFrame: Baseline to follow-up at 1 year
measure: Body Mass Index (BMI)
timeFrame: Baseline to follow-up at 1 year
measure: Current Tobacco Use
timeFrame: Current tobacco use measured at Baseline and Follow up at one year
measure: Low Density Lipoprotein Cholesterol (LDL-c).
timeFrame: Baseline to follow-up at 1 year
measure: Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score
timeFrame: Baseline to follow-up at 1 year
measure: Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS)
timeFrame: Baseline to follow-up at 1 year
measure: Number of Hospitalizations
timeFrame: Baseline to follow-up at 1 year
measure: Number of Emergency Room (ER) Visits
timeFrame: Baseline to follow-up at 1 year
measure: Number of Outpatient Clinic/Primary Care Visits
timeFrame: Baseline to follow-up at 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Karin M. Nelson, MD MSHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.