Trial Outcomes & Findings for Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness (NCT NCT06025721)

NCT ID: NCT06025721

Last Updated: 2025-08-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: at 16 weeks
• Results posted on: 2025-08-08

Participant Flow

Participant milestones

Measure	CV-Homes Intervention Behavioral treatment by a wellness coach. 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.).
Overall Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	CV-Homes Intervention Behavioral treatment by a wellness coach. 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.).
Overall Study Physician Decision	1
Overall Study Protocol Violation	1
Overall Study Incarceration	1

Baseline Characteristics

Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness

Baseline characteristics by cohort

Measure	CV-Homes Intervention n=7 Participants Behavioral treatment by a wellness coach. 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.).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: at 16 weeks

Population: One participant did not complete the final assessment and one participant skipped this section.

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.

Outcome measures

Measure

CV-Homes Intervention n=5 Participants Behavioral treatment by a wellness coach. 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.).

Acceptability Measured by the Client Satisfaction Questionnaire

31 score on a scale Interval 30.0 to 32.0

PRIMARY outcome

Timeframe: At 16 weeks

Throughout the study we will measure engagement by tracking attendance of treatment sessions.

Outcome measures

Measure

CV-Homes Intervention n=7 Participants Behavioral treatment by a wellness coach. 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.).

Treatment Engagement Measured by Sessions Attended

6.8 sessions attended Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: Baseline included participants who completed baseline survey and began coaching. 16 weeks included participants who completed final assessment.

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, shared as a mean total of responses to the 5 questions with lower scores being higher quality of life and higher scores being lower quality of life. The highest possible score for the 5 questions on the 5-response likert scale (the sum of each response) is 25 and the lowest score is 5. The Euro-Qol also includes 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.

Outcome measures

Measure	CV-Homes Intervention n=7 Participants Behavioral treatment by a wellness coach. 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.).
Health-related Quality of Life 5-response scale Baseline	11.7 units on a scale Interval 7.0 to 16.0
Health-related Quality of Life 5-resonse scale 16 weeks	10.2 units on a scale Interval 6.0 to 19.0
Health-related Quality of Life 1-100 scale Baseline	58.6 units on a scale Interval 35.0 to 75.0
Health-related Quality of Life 1-100 scale 16 weeks	65 units on a scale Interval 44.0 to 78.0

SECONDARY outcome

Timeframe: Baseline to 16 weeks

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.

Outcome measures

Measure	CV-Homes Intervention n=6 Participants Behavioral treatment by a wellness coach. 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.).
Cardiovascular Health (AHA Life's Essential 8) Baseline	52.92 score on a scale Standard Deviation 10.73
Cardiovascular Health (AHA Life's Essential 8) Final Assessment	55.52 score on a scale Standard Deviation 9.74

Adverse Events

CV-Homes Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katherine Diaz Vickery

Hennepin Healthcare Research Institute

Phone: 612-873-6852

Email: katherine.vickery@hcmed.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place