Diabetes Homeless Medication Support Randomized Pilot Treatment Development Trial (D-Homes)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Experience During the Intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
D-Homes intervention
Behavioral treatments by a diabetes wellness coach as defined below.
Intervention: Diabetes Homeless Medication Support (D-Homes) (Behavioral)
D-Homes intervention
Behavioral treatments by a diabetes wellness coach as defined below.
Intervention: Enhanced usual care (Behavioral)
Enhanced usual care
Brief diabetes educational session by a diabetes wellness coach.
Intervention: Enhanced usual care (Behavioral)
Outcomes
Primary Outcomes
Experience During the Intervention
Time Frame: 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
Time Frame: 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 Outcomes
- Change in Glycemic Control(Assessed at Baseline, 16 weeks, and 30 weeks.)
- Psychological Wellness(Assessed at baseline, 16 weeks, and 30 weeks)
- Diabetes Medication Adherence(Assessed at Baseline, 16 weeks, and 30 weeks)