Heart DiseasesCV-HomesNCT06025721
Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness
A study testing Cardiovascular Risk Homeless Support in people with Heart Diseases and Diabetes Mellitus, Type 2, run by Katherine Vickery at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases, Diabetes Mellitus, Type 2, Pre-diabetes
- What is being tested?
- Cardiovascular Risk Homeless Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2024to 16 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active intoxication
- Active psychosis
- Presence of a legal guardian
- Pregnant or lactating people
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55404
About this study
Official title: Development of a Multiple Health Behavior Change Intervention for Cardiovascular Risk Reduction Among People Who Have Experienced Homelessness: The CV-HOMES Study
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.
Read the 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.
- Being tested
- Cardiovascular Risk Homeless Support
- Keywords
- Cardiovascular Health, Homeless persons, Delivery of Health Care, Integrated, Primary care, Social determinants of health
- Medical subject headings
- Heart Diseases, Diabetes Mellitus, Type 2, Glucose Intolerance, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Risk Homeless SupportBehavioural
Also called CV-Homes
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.).
| Study group | Role | What they receive |
|---|---|---|
| CV-Homes Intervention | Experimental | Behavioral treatment by a wellness coach. Receives: Behavioral: Cardiovascular Risk Homeless Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 16 weeks
Treatment Engagement Measured by Sessions Attended
Throughout the study we will measure engagement by tracking attendance of treatment sessions.
Measured: At 16 weeks
Secondary outcomes (2)
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, 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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start5 Jan 2024
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katherine Vickery
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Minnesota, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor-investigator, Katherine Vickery, Hennepin Healthcare Research Institute
- Investigators
- Katherine D Vickery, MD, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025721
- Sponsor's protocol ID
- IRB-FY2022-373
- Other IDs
- P50MD017342
- Acronym
- CV-Homes
- Status last verified
- Jul 2025
- First submitted
- 29 Aug 2023
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35766027Gathright 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.
PubMed 35113860
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multiple Health Behavior Change Intervention for Cardiovascular Risk Reduction Among People Who Have Experienced Homelessness: The CV-HOMES Study
- ClinicalTrials.gov ID
- NCT06025721
- Acronym / sponsor ID
- CV-Homes / IRB-FY2022-373
- Keywords
- Cardiovascular Health, Homeless persons, Delivery of Health Care, Integrated, Primary care, Social determinants of health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Katherine VickeryUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Minnesota, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Posted 8 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| CV-Homes Intervention | Experimental | Behavioral: Cardiovascular Risk Homeless SupportBehavioral treatment by a wellness coach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Active intoxication
- Active psychosis
- Presence of a legal guardian
- Pregnant or lactating people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Risk Homeless SupportAlso: CV-HomesThere 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.). | Behavioural | CV-Homes Intervention |
Primary outcome
Acceptability Measured by the Client Satisfaction Questionnaire
Time frame: 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
Time frame: At 16 weeks
Throughout the study we will measure engagement by tracking attendance of treatment sessions.
2 secondary outcomes
Health-related Quality of Life
Time frame: Baseline to 16 weeks
Cardiovascular Health (AHA Life's Essential 8)
Time frame: Baseline to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35766027Lloyd-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.
- Background: PubMed 35113860Gathright 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine D Vickery, MD principal investigator
Hennepin Healthcare Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular Risk Homeless Support in people with Heart Diseases and Diabetes Mellitus, Type 2, run by Katherine Vickery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability Measured by the Client Satisfaction Questionnaire (time frame: at 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06025721, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.