NCT02697422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

June 1, 2024

Enrollment Period

4.6 years

First QC Date

February 16, 2016

Results QC Date

January 25, 2023

Last Update Submit

June 28, 2024

Conditions

Keywords

Smoking (tobacco use)Peer health coachSystolic blood pressureFramingham Cardiovascular risk scoreLipidHealth related quality of lifeHealth care utilizationMedication adherencePhysical activityNutritionAlcohol useStress management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Framingham Cardiovascular Risk Score (FRS)

    Baseline to follow-up at 1 year

  • Body Mass Index (BMI)

    Baseline to follow-up at 1 year

  • Current Tobacco Use

    Current tobacco use measured at Baseline and Follow up at one year

  • Low Density Lipoprotein Cholesterol (LDL-c).

    Baseline to follow-up at 1 year

  • Change in Health-Related Quality of Life (HRQoL), Mental Component Summary Score

    Baseline to follow-up at 1 year

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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).

Also known as: Vet-Coach intervention
Peer health coach intervention group

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seattle, Washington, 98108, United States

Location

Related Publications (3)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionHyperlipidemiasObesitySmokingTobacco UsePatient Acceptance of Health CareMedication AdherenceMotor ActivityAlcohol Drinking

Condition Hierarchy (Ancestors)

Vascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorTreatment Adherence and ComplianceHealth BehaviorPatient ComplianceDrinking Behavior

Results Point of Contact

Title
Dr. Karin Nelson
Organization
VA Puget Sound Health Care System

Study Officials

  • Karin M. Nelson, MD MSHS

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
N/A; No masking will occur in this clinical trial.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel: Participants are assigned to one of two groups--the control or intervention group- in parallel for the duration of the study.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2016

First Posted

March 3, 2016

Study Start

May 30, 2017

Primary Completion

January 6, 2022

Study Completion

February 28, 2023

Last Updated

August 9, 2024

Results First Posted

August 9, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

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.

Locations