Clinical trial NCT06025721: Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness
Official title: Development of a Multiple Health Behavior Change Intervention for Cardiovascular Risk Reduction Among People Who Have Experienced Homelessness: the CV-HOMES Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Minnesota
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-09-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability Measured by the Client Satisfaction Questionnaire
timeFrame: at 16 weeks
measure: Treatment Engagement Measured by Sessions Attended
timeFrame: At 16 weeks
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Baseline to 16 weeks
measure: Cardiovascular health (AHA Life's Essential 8)
timeFrame: Baseline to 16 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Katherine D Vickery, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.
citation: Gathright EC, Vickery KD, Ayenew W, Whited MC, Adkins-Hempel M, Chrastek M, Carter JK, Rosen RK, Wu WC, Busch AM. The development and pilot testing of a behavioral activation-based treatment for depressed mood and multiple health behavior change in patients with recent acute coronary syndrome. PLoS One. 2022 Feb 3;17(2):e0261490. doi: 10.1371/journal.pone.0261490. eCollection 2022.