Cardiovascular Disease (CVD)Vet-COACHNCT02697422

Veteran Peer Coaches Optimizing and Advancing Cardiac Health

A study testing Community-based peer health coach intervention in people with Cardiovascular Disease (CVD) and Hypertension, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 75 years
Conditions the study is for: Cardiovascular Disease (CVD), Hypertension, Hyperlipemia
What is being tested?: Community-based peer health coach intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 264 participants
Where: 1 siteUnited States
Study dates: 30 May 2017to 28 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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)

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Cardiovascular Disease (CVD), Hypertension, Hyperlipemia, Obesity
Being tested: Community-based peer health coach intervention
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
Medical subject headings: Cardiovascular Diseases, Hypertension, Hyperlipidemias, Obesity, Smoking, Tobacco Use, Patient Acceptance of Health Care, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Community-based peer health coach interventionOther
Also called Vet-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).

Study groups in NCT02697422
Study group	Role	What they receive
Peer health coach intervention group	Experimental	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. Receives: Other: Community-based peer health coach intervention
Control group	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to follow-up at 1 year

Secondary outcomes (9)

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to follow-up at 1 year
Number of Hospitalizations
Health care hospitalization utilization are measured using VA administrative data.
Measured: 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.
Measured: 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.
Measured: Baseline to follow-up at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 201728 Feb 2023

First posted3 Mar 2016 (estimated)
Study start30 May 2017
Primary completion6 Jan 2022
Study completion28 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cardiovascular Disease (CVD)Studies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 264 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02697422
Sponsor's protocol ID: IIR 14-063
Acronym: Vet-COACH
Status last verified: Jun 2024
First submitted: 16 Feb 2016
Last updated: 9 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

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.
PubMed 30172037
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.
PubMed 37278999
Kramer CB, Nelson KM, Sayre G, Williams JL, Spruill L, Fennell T, Gray KE, Weiner BJ, Fan V, Jones-Smith J, Rao M. "Veteran to Veteran, There's Automatically a Trust": A Qualitative Study of Veterans' Experiences in a Peer Health-Coaching Program for Hypertension. AJPM Focus. 2024 Jul 3;3(6):100257. doi: 10.1016/j.focus.2024.100257. eCollection 2024 Dec.
PubMed 39415799

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vet COACH (Veteran Peer Coaches Optimizing and Advancing Cardiac Health)
ClinicalTrials.gov ID: NCT02697422
Acronym / sponsor ID: Vet-COACH / IIR 14-063
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 264 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 30 May 2017 (actual)
Primary completion: 6 Jan 2022 (actual)
Study completion: 28 Feb 2023 (actual)
First posted: 3 Mar 2016 (estimated)
Results: Posted 9 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Parallel: Participants are assigned to one of two groups--the control or intervention group- in parallel for the duration of the study.

Arm	Type	Receives
Peer health coach intervention group	Experimental	Other: Community-based peer health coach interventionEligible 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.
Control group	No intervention	–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.

Who may qualify

Ages: Up to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Community-based peer health coach interventionAlso: Vet-Coach interventionThe 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	Peer health coach intervention group

Primary outcome

Change in Systolic Blood Pressure (SBP)
Time frame: Baseline to follow-up at 1 year
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.

9 secondary outcomes

Framingham Cardiovascular Risk Score (FRS)
Time frame: Baseline to follow-up at 1 year
Body Mass Index (BMI)
Time frame: Baseline to follow-up at 1 year
Current Tobacco Use
Time frame: Current tobacco use measured at Baseline and Follow up at one year
Low Density Lipoprotein Cholesterol (LDL-c).
Time frame: Baseline to follow-up at 1 year
Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score
Time frame: Baseline to follow-up at 1 year
Change in Health-Related Quality of Life (HRQoL), Physical Component Summary Score (PCS)
Time frame: Baseline to follow-up at 1 year
Number of Hospitalizations
Time frame: Baseline to follow-up at 1 year
Number of Emergency Room (ER) Visits
Time frame: Baseline to follow-up at 1 year
Number of Outpatient Clinic/Primary Care Visits
Time frame: Baseline to follow-up at 1 year

Results and safety

Results posted to the registry on 9 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Peer Health Coach Intervention Group	134	108
Control Group	130	117

Primary outcome: Change in Systolic Blood Pressure (SBP)

Time frame: Baseline to follow-up at 1 year. Mean (95% Confidence Interval). Unit: mm Hg

Measure	Peer Health Coach Intervention Group n = 134	Control Group n = 130
Value	-3.32 (-6.88 to 0.23)	-0.40 (-4.20 to 3.39)

Peer Health Coach Intervention Group vs Control Group: p = 0.05, Regression, Linear

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to follow up at 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peer Health Coach Intervention Group	0 of 134 (0%)	0 of 134 (0%)	2 of 134
Control Group	0 of 130 (0%)	0 of 130 (0%)	1 of 130

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30172037Nelson 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 publication: PubMed 37278999Nelson 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.
Derived from this study: PubMed 39415799Kramer CB, Nelson KM, Sayre G, Williams JL, Spruill L, Fennell T, Gray KE, Weiner BJ, Fan V, Jones-Smith J, Rao M. "Veteran to Veteran, There's Automatically a Trust": A Qualitative Study of Veterans' Experiences in a Peer Health-Coaching Program for Hypertension. AJPM Focus. 2024 Jul 3;3(6):100257. doi: 10.1016/j.focus.2024.100257. eCollection 2024 Dec.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karin M. Nelson, MD MSHS principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Community-based peer health coach intervention in people with Cardiovascular Disease (CVD) and Hypertension, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic Blood Pressure (SBP) (time frame: Baseline to follow-up at 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02697422, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.