Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness (CV-Homes)

July 22, 2025 updated by: Katherine Vickery

Development of a Multiple Health Behavior Change Intervention for Cardiovascular Risk Reduction Among People Who Have Experienced Homelessness: The CV-HOMES Study

This single-arm trial of the Cardiovascular Risk Reduction Among People Experiencing Homelessness (CV-Homes) intervention alone (n=8) will test the perception and feasibility of anticipated study procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is of a set of studies with an overall goal to develop and pilot test a collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and cardiovascular health risks (CV-H). Our team's central hypothesis is that medication adherence and cardiovascular self-care (and eventual glycemic control, cholesterol control, health care use/cost) will improve with an intervention tailored to the unique context of CV-H.

This protocol addresses a pilot study to test patient perceptions of the feasibility and acceptability of study procedures and refine the CV-Homes treatment manual through test cases (n=8). With a hypothesis that the CV-Homes manual and study procedures will be feasible and acceptable to CV-H as measured by self-report and post-treatment interview.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Hennepin Healthcare Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 yrs. or older
  • English-speaking
  • Living at Catholic Charities' Endeavors residence (Minneapolis, MN)
  • Self-reported diagnosis of moderate or high CVD risk, defined as being told by a medical professional that the participant has hypertension, heart disease, hypercholesterolemail, prediabetes, or type 2 diabetes
  • Plan to stay in local area or be reachable by phone for the next 16 weeks
  • Willingness to work on one or more CVD risk reduction behavior change

Exclusion Criteria:

  • Active intoxication
  • Active psychosis
  • Presence of a legal guardian
  • Pregnant or lactating people

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CV-Homes Intervention
Behavioral treatment by a wellness coach.
Behavioral: Cardiovascular Risk Homeless Support
There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve cardiovascular health behaviors. The coach will encourage a focus on smoking>medication>sleep>physical activity>healthy eating to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief cardiovascular health education as needed in participants' preferred format (handout, video, audio, etc.).
Other Names:
  • CV-Homes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability Measured by the Client Satisfaction Questionnaire
Time Frame: at 16 weeks
This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire, with a score range 8-32, higher score indicating greater satisfaction.
at 16 weeks
Treatment Engagement Measured by Sessions Attended
Time Frame: At 16 weeks
Throughout the study we will measure engagement by tracking attendance of treatment sessions.
At 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life
Time Frame: Baseline to 16 weeks
Health related quality of life as measured by the Euro-Qol 5D-5-L which asks 5 questions on a 5-response likert scale with 1 = no problems and 5= unable to, shared as a mean total of responses to the 5 questions with lower scores being higher quality of life and higher scores being lower quality of life. The highest possible score for the 5 questions on the 5-response likert scale (the sum of each response) is 25 and the lowest score is 5. The Euro-Qol also includes one question on a scale of 1-100 with 1 being the worst health one can imagine and 100 being the best health one can imagine.
Baseline to 16 weeks
Cardiovascular Health (AHA Life's Essential 8)
Time Frame: Baseline to 16 weeks
Composite measure of self-reported behaviors (healthy eating, physical activity, tobacco use, sleep) and biometric measures (BMI, Blood pressure, Cholesterol, HbA1c). Score is 0-100 with higher scores meaning better cardiovascular health.
Baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Katherine Vickery

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
National Institutes of Health (NIH)
University of Minnesota

Investigators

  • Principal Investigator: Katherine D Vickery, MD, Hennepin Healthcare Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Actual)

October 16, 2024

Study Completion (Actual)

October 16, 2024

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2022-373
  • P50MD017342 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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