Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness

Hypertension Clinical Trial

— CV-Homes  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025721
• Other study ID #: IRB-FY2022-373
• Secondary ID: P50MD017342
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Hennepin Healthcare Research Institute
• Contact: Katherine D Vickery, MD
• Phone: 6128736852
• Email: katherine.vickery[@]hcmed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Diseases
• Hyperlipidemias
• Hypertension
• Pre-diabetes
• Prediabetic State

Intervention

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 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.).

Locations

Country	Name	City	State
United States	Hennepin Healthcare Research Institute	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH), University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Treatment Engagement Measured by Sessions Attended	Throughout the study we will measure engagement by tracking attendance of treatment sessions.	At 16 weeks
Secondary	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
Secondary	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