Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness

Not Applicable

Completed

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

• Registration Number: NCT06025721
• Lead Sponsor: Hennepin Healthcare Research Institute

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.

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-06
• Study Start: 2024-01-05
• Primary Completion: 2024-10-16
• Study Completion: 2024-10-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acceptability Measured by the Client Satisfaction Questionnaire	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.
Treatment Engagement Measured by Sessions Attended	At 16 weeks	Throughout the study we will measure engagement by tracking attendance of treatment sessions.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	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; and 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.
Cardiovascular health (AHA Life's Essential 8)	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.

Trial Locations

Locations (1)

Hennepin Healthcare Research Institute; 🇺🇸 Minneapolis, Minnesota, United States