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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
38
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).
Hennepin Healthcare
Minneapolis, Minnesota, United States
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.
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Time frame: Assessed at Baseline, 16 weeks, and 30 weeks