Diabetes Mellitus, Type 2, Housing Problems, Psychological Distress
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
BEHAVIORALEnhanced usual care
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).
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Study staff completing post-treatment assessments will be blinded to study condition allocation.
Intervention model description
The study team will use 1 to 1 allocation to intervention vs. comparison arms. They will stratify based on more and less stable housing in the 12 mo. prior to enrollment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 yrs. or older 2. English-speaking 3. Homelessness by federal definition (HEARTH ACT) in the past 24 mos. 4. Self-reported diagnosis of type 2 diabetes with A1c \>7.5%, later verified in medical record and study point-of-care lab test. 5. Plan to stay in local area or be reachable by phone for the next 24 weeks 6. Willingness to work on medication adherence and diabetes self-care
Exclusion criteria
1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners) 2. Active psychosis or intoxication precluding ability to give informed consent 3. Pregnant or lactating people
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Experience During the Intervention | Assessed at 16 weeks | 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. |
| Retention in Assessments | Assessed at 30 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycemic Control | Assessed at Baseline, 16 weeks, and 30 weeks. | 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. |
| Psychological Wellness | Assessed at baseline, 16 weeks, and 30 weeks | 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. |
| Diabetes Medication Adherence | Assessed at Baseline, 16 weeks, and 30 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| D-Homes Intervention Behavioral treatments by a diabetes wellness coach as defined below.
Diabetes Homeless Medication Support (D-Homes): 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.
Enhanced usual care: 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). | 18 |
| Enhanced Usual Care Brief diabetes educational session by a diabetes wellness coach.
Enhanced usual care: 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). | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Deviation w/o increased risk to pt | 1 | 1 |
Baseline characteristics
| Characteristic | D-Homes Intervention | Total | Enhanced Usual Care |
|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 10.2 | 52.06 years STANDARD_DEVIATION 10.34 | 51.9 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 34 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 26 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 18 participants | 36 participants | 18 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 13 Participants | 25 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| D-Homes Intervention | Experience During the Intervention | 29.06 score on a scale | Standard Deviation 4.26 |
| Enhanced Usual Care | Experience During the Intervention | 28.22 score on a scale | Standard Deviation 3.66 |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D-Homes Intervention | Retention in Assessments | 100 percentage of pts |
| Enhanced Usual Care | Retention in Assessments | 89 percentage of pts |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| D-Homes Intervention | Change in Glycemic Control | Baseline | 10.3 percentage of HbA1c | Standard Deviation 2.1 |
| D-Homes Intervention | Change in Glycemic Control | 16 weeks | 9.7 percentage of HbA1c | Standard Deviation 2.3 |
| D-Homes Intervention | Change in Glycemic Control | 30 weeks | 9.7 percentage of HbA1c | Standard Deviation 2.7 |
| Enhanced Usual Care | Change in Glycemic Control | Baseline | 10.4 percentage of HbA1c | Standard Deviation 2.2 |
| Enhanced Usual Care | Change in Glycemic Control | 16 weeks | 9.6 percentage of HbA1c | Standard Deviation 2.4 |
| Enhanced Usual Care | Change in Glycemic Control | 30 weeks | 9.6 percentage of HbA1c | Standard Deviation 2.4 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| D-Homes Intervention | Diabetes Medication Adherence | Baseline | 15.6 score on a scale | Standard Deviation 4.6 |
| D-Homes Intervention | Diabetes Medication Adherence | 16 weeks | 16.0 score on a scale | Standard Deviation 5.2 |
| D-Homes Intervention | Diabetes Medication Adherence | 30 weeks | 15.2 score on a scale | Standard Deviation 5.2 |
| Enhanced Usual Care | Diabetes Medication Adherence | Baseline | 17.2 score on a scale | Standard Deviation 3.9 |
| Enhanced Usual Care | Diabetes Medication Adherence | 16 weeks | 16.7 score on a scale | Standard Deviation 3.4 |
| Enhanced Usual Care | Diabetes Medication Adherence | 30 weeks | 16.1 score on a scale | Standard Deviation 3.7 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| D-Homes Intervention | Psychological Wellness | Baseline | 34.4 score on a scale | Standard Deviation 24.9 |
| D-Homes Intervention | Psychological Wellness | 16 weeks | 38 score on a scale | Standard Deviation 20.2 |
| D-Homes Intervention | Psychological Wellness | 30 weeks | 34.7 score on a scale | Standard Deviation 20.6 |
| Enhanced Usual Care | Psychological Wellness | Baseline | 39.8 score on a scale | Standard Deviation 21.2 |
| Enhanced Usual Care | Psychological Wellness | 16 weeks | 37.6 score on a scale | Standard Deviation 17.3 |
| Enhanced Usual Care | Psychological Wellness | 30 weeks | 36.7 score on a scale | Standard Deviation 24.4 |