Diabetes Mellitus, Type 2, Heart Diseases, Hyperlipidemias, Hypertension, Pre-diabetes
Conditions
Keywords
Cardiovascular Health, Homeless persons, Delivery of Health Care, Integrated, Primary care, Social determinants of health
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.
Interventions
BEHAVIORALCardiovascular 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.).
Sponsors
National Institutes of Health (NIH)
University of Minnesota
National Institute on Minority Health and Health Disparities (NIMHD)
Katherine Vickery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Measured by the Client Satisfaction Questionnaire | 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 | At 16 weeks | Throughout the study we will measure engagement by tracking attendance of treatment sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life | Baseline to 16 weeks | 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. |
| Cardiovascular Health (AHA Life's Essential 8) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.). | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Incarceration | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | CV-Homes Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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.
Time frame: at 16 weeks
Population: One participant did not complete the final assessment and one participant skipped this section.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CV-Homes Intervention | Acceptability Measured by the Client Satisfaction Questionnaire | 31 score on a scale |
Primary
Treatment Engagement Measured by Sessions Attended
Throughout the study we will measure engagement by tracking attendance of treatment sessions.
Time frame: At 16 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CV-Homes Intervention | Treatment Engagement Measured by Sessions Attended | 6.8 sessions attended |
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.
Time frame: Baseline to 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CV-Homes Intervention | Cardiovascular Health (AHA Life's Essential 8) | Baseline | 52.92 score on a scale | Standard Deviation 10.73 |
| CV-Homes Intervention | Cardiovascular Health (AHA Life's Essential 8) | Final Assessment | 55.52 score on a scale | Standard Deviation 9.74 |
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, 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.
Time frame: Baseline to 16 weeks
Population: Baseline included participants who completed baseline survey and began coaching. 16 weeks included participants who completed final assessment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CV-Homes Intervention | Health-related Quality of Life | 5-response scale Baseline | 11.7 units on a scale |
| CV-Homes Intervention | Health-related Quality of Life | 5-resonse scale 16 weeks | 10.2 units on a scale |
| CV-Homes Intervention | Health-related Quality of Life | 1-100 scale Baseline | 58.6 units on a scale |
| CV-Homes Intervention | Health-related Quality of Life | 1-100 scale 16 weeks | 65 units on a scale |