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

Primary Purpose

Cardiovascular Disease (CVD), Hypertension, Hyperlipemia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community-based peer health coach intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Disease (CVD) focused on measuring 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

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peer health coach intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reduction in systolic blood pressure
Reduction in systolic blood pressure.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 16, 2016
Last Updated
February 3, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02697422
Brief Title
Veteran Peer Coaches Optimizing and Advancing Cardiac Health
Acronym
Vet-COACH
Official Title
Vet COACH (Veteran Peer Coaches Optimizing and Advancing Cardiac Health)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer health coach intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Community-based peer health coach intervention
Other Intervention Name(s)
Vet-Coach intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reduction in systolic blood pressure
Description
Reduction in systolic blood pressure.
Time Frame
Baseline to follow-up at 1 year
Secondary Outcome Measure Information:
Title
Reduction in Framingham Cardiovascular risk score
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
Tobacco use
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
Overall Health, 12-Item Short-Form Health Survey
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
Number of outpatient clinic visits, ER visits and hospitalizations in the previous year
Description
Health care utilization will be measured using VA administrative data, including number of outpatient and ER visits, hospitalizations during the previous year.
Time Frame
Baseline to follow-up at 1 year
Title
Body Mass Index (BMI)
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
Low density lipoprotein cholesterol (LDL-c).
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
Participant self-reported use of non-VA care services, High Risk Patient Survey
Description
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.
Time Frame
Baseline to follow-up at 1 year
Other Pre-specified Outcome Measures:
Title
Social Support
Description
The 8-item Medical Outcomes Study (MOS) Social Support Survey Instrument will be used to measure self-perceived overall social support, including community support.
Time Frame
Baseline to follow-up at 1 year
Title
Patient Activation, Consumer Health Activation Index (CHAI)
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
Consumer Assessment of Health Plans (CAHPS) Clinician & Group Survey and Reporting Kit (Four-Point Scale)
Description
The CAHPS survey will be used to measure patient satisfaction and patient/provider communication with the participant's physician and health care team.
Time Frame
Baseline to follow-up at 1 year
Title
International Physical Activity Questionnaire (IPAQ), Short
Description
The IPAQ will be used to measure exercise and physical activity, which will assess self-management health behaviors.
Time Frame
Baseline to follow-up at 1 year
Title
Self-reported medication non-adherence questions
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
Nutrition, "Starting the conversation brief dietary assessment and intervention scale"
Description
The tool will be used to measure nutrition from eating, which will be used to assess self-management health behaviors.
Time Frame
Baseline to follow-up at 1 year
Title
Food Frequency Questionnaire (FFQ)
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
The AUDIT Alcohol Consumption questionnaire (AUDIT-C)
Description
AUDIT-C questionnaire will measure alcohol use, which will be used to assess self-management health behaviors.
Time Frame
Baseline to follow-up at 1 year
Title
Overall Health, 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity
Description
The 12-Item Short-Form Health Survey will be used to measure overall health, which will be used to assess self-management health behaviors.
Time Frame
Baseline to follow-up at 1 year
Title
Food security
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
Provider Communication
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
Blood Pressure Self Management Behaviors
Description
Self Management Behaviors to control blood pressure will be measured by questions taken from the Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2009
Time Frame
Baseline to follow-up at 1 year
Title
Neighborhood Utilization, The Chronic Illness Resources Survey
Description
Utilization of neighborhood resources will be assessed using the Chronic Illness Resources Survey: Cross-validation and sensitivity to intervention.
Time Frame
Baseline to follow-up at 1 year
Title
Patient Mental Health, The PHQ-8: A New Depression Diagnostic and Severity Measure
Description
Patient Mental Health will be measured using the PHQ-8: A New Depression Diagnostic and Severity Measure
Time Frame
Baseline to follow-up at 1 year
Title
Health Literacy
Description
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.
Time Frame
Baseline to follow-up at 1 year
Title
Caregiver Support
Description
The Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire will measure caregiver support.
Time Frame
Baseline to follow-up at 1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin M. Nelson, MD MSHS
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
30172037
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.
Results Reference
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Veteran Peer Coaches Optimizing and Advancing Cardiac Health

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