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

Katherine Vickery

Status: Completed

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

Treatments: Behavioral: Cardiovascular Risk Homeless Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06025721

IRB-FY2022-373

P50MD017342 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

CV-Homes Intervention

Experimental group

Description:

Behavioral treatment by a wellness coach.

Treatment:

Behavioral: Cardiovascular Risk Homeless Support