A Phase 2 interventional study of Diabetes Homeless Medication Support (D-Homes) and Enhanced usual care in Diabetes Mellitus, Type 2, Housing Problems and Psychological Distress, sponsored by Hennepin Healthcare Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Hennepin Healthcare Research Institute · Phase 2, Interventional, and Treatment
This randomized pilot trial of the Diabetes Homeless Medication Support intervention vs. brief diabetes education will test the perception and feasibility of anticipated study procedures and refine randomization and blinding.
This study has 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 diabetes (DH). The investigators' central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of DH.
This study will involve addition of a randomization schema to compare D-Homes to brief diabetes education. The study team will enroll participants (n=54), and refine procedures for the randomized trial outcome measures. This includes an assessment of sustained impact of the program at 24-weeks post-treatment. These will complement 12-week post-treatment primary outcome measures.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 38 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hennepin Healthcare Research Institute is the lead sponsor of 69 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Behavioral treatments by a diabetes wellness coach as defined below.
Behavioral: Diabetes Homeless Medication Support (D-Homes) · Behavioral: Enhanced usual care
Brief diabetes educational session by a diabetes wellness coach.
Behavioral: Enhanced usual care
There will be 10 sessions offered within 12 weeks to participants. Sessions will last approximately 30 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resource and care coordination. The coach will also provide a tailored tool to the patient's needs/goals and tailored diabetes education as needed.
Trained diabetes wellness coaches will provide an approximately 15 minutes of instruction about the basic concepts of diabetes. They will use handouts aligned with American Diabetes Association guidelines. They will read these with participants and answer basic questions. Handouts will cover (1) general diabetes knowledge, (2) healthy eating with diabetes, (3) physical activity with diabetes. The coach will also provide a general tool to support medication adherence (e.g. pillbox).
Experience During the Intervention
The acceptability of the intervention to participants will be measured by the Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
Time frame: Assessed at 16 weeks
Retention in Assessments
The study team will track enrolled participants who complete both post-treatment assessment visits (12-16 week post-treatment assessment and 24-30 week assessment). Retention will be measured as the percentage of enrolled participants who complete both assessments as assessed at 30 weeks.
Time frame: Assessed at 30 weeks
Change in Glycemic Control
The study team will measure glycemic control using hemoglobin A1c. This will be done on a consistent, validated point-of-care machine using fingerstick blood samples. The study team will compare glycemic control from baseline to 16 weeks and from baseline to 30 weeks.
Time frame: Assessed at Baseline, 16 weeks, and 30 weeks.
Psychological Wellness
Psychological wellness is measured with the 5-item Mental Health Inventory (MHI-5), a brief transdiagnostic screening tool attuned to broader concepts of wellbeing and distress than other available measures. MHI-5 scores are computed and transformed on a 0 to 100 point scale with higher scores indicating more wellness. We compare MHI-5 scores from baseline to 16 weeks and from baseline to 30 weeks.
Time frame: Assessed at baseline, 16 weeks, and 30 weeks
Diabetes Medication Adherence
As measured by the Adherence to Refills and Medications Scales-Diabetes (ARMS-D), Total scores range from 12-48, with higher values indicating worse outcomes. The study team will compare ARMS-D scores from baseline to 16 weeks and baseline to 30 weeks.
Time frame: Assessed at Baseline, 16 weeks, and 30 weeks
| Milestone | D-Homes Intervention | Enhanced Usual Care |
|---|---|---|
| Started | 19 | 19 |
| Completed | 18 | 16 |
| Not completed | 1 | 3 |
| Withdrew: Protocol deviation w/o increased risk to pt | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 |
The acceptability of the intervention to participants will be measured by the Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
| score on a scale | D-Homes Intervention | Enhanced Usual Care |
|---|---|---|
| Experience During the Intervention | 29.06 ± 4.26 | 28.22 ± 3.66 |
The study team will track enrolled participants who complete both post-treatment assessment visits (12-16 week post-treatment assessment and 24-30 week assessment). Retention will be measured as the percentage of enrolled participants who complete both assessments as assessed at 30 weeks.
| percentage of pts | D-Homes Intervention | Enhanced Usual Care |
|---|---|---|
| Retention in Assessments | 100 | 89 |
The study team will measure glycemic control using hemoglobin A1c. This will be done on a consistent, validated point-of-care machine using fingerstick blood samples. The study team will compare glycemic control from baseline to 16 weeks and from baseline to 30 weeks.
| percentage of HbA1c | D-Homes Intervention | Enhanced Usual Care |
|---|---|---|
| Baseline | 10.3 ± 2.1 | 10.4 ± 2.2 |
| 16 weeks | 9.7 ± 2.3 | 9.6 ± 2.4 |
| 30 weeks | 9.7 ± 2.7 | 9.6 ± 2.4 |
Psychological wellness is measured with the 5-item Mental Health Inventory (MHI-5), a brief transdiagnostic screening tool attuned to broader concepts of wellbeing and distress than other available measures. MHI-5 scores are computed and transformed on a 0 to 100 point scale with higher scores indicating more wellness. We compare MHI-5 scores from baseline to 16 weeks and from baseline to 30 weeks.
| score on a scale | D-Homes Intervention | Enhanced Usual Care |
|---|---|---|
| Baseline | 34.4 ± 24.9 | 39.8 ± 21.2 |
| 16 weeks | 38 ± 20.2 | 37.6 ± 17.3 |
| 30 weeks | 34.7 ± 20.6 | 36.7 ± 24.4 |
As measured by the Adherence to Refills and Medications Scales-Diabetes (ARMS-D), Total scores range from 12-48, with higher values indicating worse outcomes. The study team will compare ARMS-D scores from baseline to 16 weeks and baseline to 30 weeks.
| score on a scale | D-Homes Intervention | Enhanced Usual Care |
|---|---|---|
| Baseline | 15.6 ± 4.6 | 17.2 ± 3.9 |
| 16 weeks | 16.0 ± 5.2 | 16.7 ± 3.4 |
| 30 weeks | 15.2 ± 5.2 | 16.1 ± 3.7 |
Collected over Each participant was assessed for adverse events for the duration of their participation from baseline to 30 weeks for a total of up to 30 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| D-Homes Intervention | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Enhanced Usual Care | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
Data from one participant from the intervention group and one participant from the enhanced usual care group were not analyzed due to their withdrawal from the study as a result of a protocol deviation.
| Age, Continuous(years) | D-Homes Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 52.2 ± 10.2 | 51.9 ± 10.8 | 52.06 ± 10.34 |
| Sex: Female, Male(Participants) | D-Homes Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 13 | 12 | 25 |
| Ethnicity (NIH/OMB)(Participants) | D-Homes Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 17 | 17 | 34 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | D-Homes Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 12 | 26 |
| White | 0 | 2 | 2 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Region of Enrollment(participants) | D-Homes Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| United States | 18 | 18 | 36 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — As this work is pilot data to inform treatment development for later efficacy testing, we will not share individual participant data. The study team will submit for publication an overall paper describing our results and how they informed future intervention development.
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Hennepin Healthcare Research Institute