Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness

NCT ID: NCT06025721

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-05
• Study Completion Date: 2024-10-16

Brief Summary

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.

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.

Conditions

Heart Diseases; Diabetes Mellitus, Type 2; Pre-diabetes; Hypertension; Hyperlipidemias

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CV-Homes Intervention

Behavioral treatment by a wellness coach.

Group Type: EXPERIMENTAL

Cardiovascular Risk Homeless Support

Intervention Type: BEHAVIORAL

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.).

Interventions

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.).

Intervention Type: BEHAVIORAL

Other Intervention Names

CV-Homes

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Katherine Vickery

OTHER

Sponsor Role: lead

Responsible Party

Katherine Vickery

Katherine Vickery, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Katherine D Vickery, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin Healthcare Research Institute

Locations

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, United States

Countries

United States

References

Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.

Reference Type: BACKGROUND

PMID: 35766027 (View on PubMed)

Gathright EC, Vickery KD, Ayenew W, Whited MC, Adkins-Hempel M, Chrastek M, Carter JK, Rosen RK, Wu WC, Busch AM. The development and pilot testing of a behavioral activation-based treatment for depressed mood and multiple health behavior change in patients with recent acute coronary syndrome. PLoS One. 2022 Feb 3;17(2):e0261490. doi: 10.1371/journal.pone.0261490. eCollection 2022.

Reference Type: BACKGROUND

PMID: 35113860 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P50MD017342

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-FY2022-373

Identifier Type: -

Identifier Source: org_study_id