Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness

NCT06025721 | Completed Results

• 2 other identifiers: IRB-FY2022-373P50MD017342
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cardiovascular Health; Homeless persons; Delivery of Health Care, Integrated; Primary care; Social determinants of health

Outcome Measures

Primary Outcomes (2)

• Acceptability Measured by the Client Satisfaction Questionnaire

  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

  Throughout the study we will measure engagement by tracking attendance of treatment sessions.

  At 16 weeks

Secondary Outcomes (2)

• Health-related Quality of Life

  Baseline to 16 weeks

• Cardiovascular Health (AHA Life's Essential 8)

  Baseline to 16 weeks

Study Arms (1)

CV-Homes Intervention

EXPERIMENTAL

Behavioral treatment by a wellness coach.

Behavioral: Cardiovascular Risk Homeless Support

Interventions

Cardiovascular Risk Homeless Support 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.).

Also known as: CV-Homes

CV-Homes Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Katherine Vickery: lead
• National Institutes of Health (NIH): collaborator
• University of Minnesota: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (2)

• 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.

  PMID: 35766027 BACKGROUND

• 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.

  PMID: 35113860 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Diabetes Mellitus, Type 2; Glucose Intolerance; Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Results Point of Contact

• Title: Katherine Diaz Vickery
• Organization: Hennepin Healthcare Research Institute

katherine.vickery@hcmed.org

612-873-6852

Study Officials

• Katherine D Vickery, MD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Katherine Vickery, MD

Model Details: This will be an in-person, phone, or video based behavioral intervention. It will involve a wellness coach assisting participants to set goals related to diabetes self-care and co-morbitities or social conditions that get in the way of health and wellness. There will be encouragement to work on medication adherence and to address getting healthy sleep, quitting tobacco, being more active, and eating better.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: January 5, 2024
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: August 8, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)