Veteran Peer Coaches Optimizing and Advancing Cardiac Health

Obesity Clinical Trial

— Vet-COACH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02697422
• Other study ID #: IIR 14-063
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 264
• Est. completion date: February 28, 2023
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Disease (CVD)
• Cardiovascular Diseases
• Hyperlipemia
• Hyperlipidemias
• Hypertension
• Obesity

Intervention

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).

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Caregiver Support	The Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire will measure caregiver support.	Baseline to follow-up at 1 year
Primary	Reduction in systolic blood pressure	Reduction in systolic blood pressure.	Baseline to follow-up at 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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