Diabetes Homeless Medication Support
D-HOMES
2 other identifiers
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus-type-2
Started Feb 2022
Typical duration for phase_2 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2022
CompletedStudy Start
First participant enrolled
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2023
CompletedResults Posted
Study results publicly available
November 7, 2024
CompletedNovember 7, 2024
November 1, 2024
1.2 years
February 17, 2022
May 13, 2024
November 6, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Assessed at 30 weeks
Secondary Outcomes (3)
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
Study Arms (2)
D-Homes intervention
EXPERIMENTALBehavioral treatments by a diabetes wellness coach as defined below.
Enhanced usual care
ACTIVE COMPARATORBrief diabetes educational session by a diabetes wellness coach.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hennepin Healthcare
Minneapolis, Minnesota, 55415, United States
Related Publications (1)
Vickery KD, Gelberg L, Hyson AR, Strother E, Carter J, Oranday Perez O, Franco M, Kavistan S, Gust S, Adair E, Anderson-Campbell A, Brito L, Butler A, Robinson T, Connett J, Evans MD, Emmons KM, Comulada WS, Busch AM. Pilot trial results of D-HOMES: a behavioral-activation based intervention for diabetes medication adherence and psychological wellness among people who have been homeless. Front Psychiatry. 2024 Feb 29;15:1329138. doi: 10.3389/fpsyt.2024.1329138. eCollection 2024.
PMID: 38487573DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to the limited resources available in the grant (career development) and delays due to the coronavirus (COVID-19) pandemic, recruitment was closed before reaching our targeted number of participants.
Results Point of Contact
- Title
- Katherine Diaz Vickery
- Organization
- Hennepin Healthcare Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine D Vickery, MD, MSc
Hennepin Healthcare Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Study staff completing post-treatment assessments will be blinded to study condition allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2022
First Posted
February 28, 2022
Study Start
February 23, 2022
Primary Completion
April 27, 2023
Study Completion
July 12, 2023
Last Updated
November 7, 2024
Results First Posted
November 7, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
As this work is pilot data to inform treatment development for later efficacy testing, we will not share individual participant data. The study team will submit for publication an overall paper describing our results and how they informed future intervention development.