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

Primary Purpose

Heart Diseases, Diabetes Mellitus, Type 2, Pre-diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiovascular Risk Homeless Support
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Diseases focused on measuring Cardiovascular Health, Homeless persons, Delivery of Health Care, Integrated, Primary care, Social determinants of health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 Exclusion Criteria: Active intoxication Active psychosis Presence of a legal guardian Pregnant or lactating people

Sites / Locations

  • Hennepin Healthcare Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CV-Homes Intervention

Arm Description

Behavioral treatment by a wellness coach.

Outcomes

Primary Outcome Measures

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.
Treatment Engagement Measured by Sessions Attended
Throughout the study we will measure engagement by tracking attendance of treatment sessions.

Secondary Outcome Measures

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.
Hemoglobin A1c
Change in point-of-care hemoglobin A1c
Total cholesterol
Change in point-of-care cholesterol

Full Information

First Posted
August 29, 2023
Last Updated
August 29, 2023
Sponsor
Hennepin Healthcare Research Institute
Collaborators
National Institutes of Health (NIH), University of Minnesota, National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT06025721
Brief Title
Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness
Acronym
CV-Homes
Official Title
Development of a Multiple Health Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness: The CV-HOMES Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
February 23, 2024 (Anticipated)
Study Completion Date
February 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hennepin Healthcare Research Institute
Collaborators
National Institutes of Health (NIH), University of Minnesota, National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CV-Homes Intervention
Arm Type
Experimental
Arm Description
Behavioral treatment by a wellness coach.
Intervention Type
Behavioral
Intervention Name(s)
Cardiovascular Risk Homeless Support
Other Intervention Name(s)
CV-Homes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability Measured by the Client Satisfaction Questionnaire
Description
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.
Time Frame
at 16 weeks
Title
Treatment Engagement Measured by Sessions Attended
Description
Throughout the study we will measure engagement by tracking attendance of treatment sessions.
Time Frame
At 16 weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
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.
Time Frame
Baseline to 16 weeks
Title
Hemoglobin A1c
Description
Change in point-of-care hemoglobin A1c
Time Frame
Baseline to 16 weeks
Title
Total cholesterol
Description
Change in point-of-care cholesterol
Time Frame
Baseline to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: Active intoxication Active psychosis Presence of a legal guardian Pregnant or lactating people
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine D Vickery, MD
Organizational Affiliation
Hennepin Healthcare Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin Healthcare Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness

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