Clinical trial NCT05258630: Diabetes Homeless Medication Support
Official title: Diabetes Homeless Medication Support Randomized Pilot Treatment Development Trial (D-Homes)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Housing Problems
Psychological Distress
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-02-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Experience During the Intervention
timeFrame: Assessed at 16 weeks
measure: Retention in Assessments
timeFrame: Assessed at 30 weeks
Secondary outcomes:
measure: Change in Glycemic Control
timeFrame: Assessed at Baseline, 16 weeks, and 30 weeks.
measure: Psychological Wellness
timeFrame: Assessed at baseline, 16 weeks, and 30 weeks
measure: Diabetes Medication Adherence
timeFrame: Assessed at Baseline, 16 weeks, and 30 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Katherine D Vickery, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: