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

Sponsor

Hennepin Healthcare Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06025721

Collaborator

National Institutes of Health (NIH) (NIH), University of Minnesota (Other), National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases Diabetes Mellitus, Type 2 Pre-diabetes Hypertension Hyperlipidemias	Behavioral: Cardiovascular Risk Homeless Support	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

Development of a Multiple Health Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness: The CV-HOMES Study

Actual Study Start Date :

May 25, 2023

Anticipated Primary Completion Date :

Feb 23, 2024

Anticipated Study Completion Date :

Feb 23, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CV-Homes Intervention Behavioral treatment by a wellness coach.	Behavioral: 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 care. The coach will encourage a focus on medication adherence behaviors 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. Other Names: CV-Homes

Arm

Intervention/Treatment

Experimental: CV-Homes Intervention

Behavioral treatment by a wellness coach.

Behavioral: 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 care. The coach will encourage a focus on medication adherence behaviors 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.

Other Names:

CV-Homes

Outcome Measures

Primary Outcome Measures

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

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.
Hemoglobin A1c [Baseline to 16 weeks]
Change in point-of-care hemoglobin A1c
Total cholesterol [Baseline to 16 weeks]
Change in point-of-care cholesterol

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 yrs. or older
English-speaking
Homelessness by federal definition in the last 12 mo.
Self-reported diagnosis of moderate or high CVD risk, defined as being told by a medical professional that the participant has hypertension, prediabetes, type 2 diabetes, or heart disease
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