Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Cardiovascular Risk Homeless Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CV-Homes Intervention<br>Behavioral treatment by a wellness coach. | Behavioral: Cardiovascular Risk Homeless Support<br>* 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.).<br>* Other names: CV-Homes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | 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. | Baseline to 16 weeks | 
| Cardiovascular health (AHA Life's Essential 8) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Health, Homeless persons, Delivery of Health Care, Integrated, Primary care, Social determinants of health