Diabetes Homeless Medication Support

Phase 2

Completed

Conditions: Psychological Distress
Housing Problems
Diabetes Mellitus, Type 2

Interventions: Behavioral: Diabetes Homeless Medication Support (D-Homes)
Behavioral: Enhanced usual care

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.

Recruitment & Eligibility

Inclusion Criteria

Age 18 yrs. or older
English-speaking
Homelessness by federal definition (HEARTH ACT) in the past 24 mos.
Self-reported diagnosis of type 2 diabetes with A1c >7.5%, later verified in medical record and study point-of-care lab test.
Plan to stay in local area or be reachable by phone for the next 24 weeks
Willingness to work on medication adherence and diabetes self-care

Exclusion Criteria

Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)
Active psychosis or intoxication precluding ability to give informed consent
Pregnant or lactating people

Arm && Interventions

Group	Intervention	Description
D-Homes intervention	Diabetes Homeless Medication Support (D-Homes)	Behavioral treatments by a diabetes wellness coach as defined below.
D-Homes intervention	Enhanced usual care	Behavioral treatments by a diabetes wellness coach as defined below.
Enhanced usual care	Enhanced usual care	Brief diabetes educational session by a diabetes wellness coach.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.