NCT05258630

Diabetes Homeless Medication Support

Diabetes Homeless Medication Support Randomized Pilot Treatment Development Trial (D-Homes)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Hennepin Healthcare Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Housing Problems
• Psychological Distress

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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).

Timeline

• Start date: 2022-02-23
• Primary completion: 2023-04-27
• Completion: 2023-07-12
• First posted: 2022-02-28
• Last updated: 2024-11-07
• Results posted: 2024-11-07

Locations

1 site across 1 country: United States