CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Diabetes Homeless Medication Support (D-Homes) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05258630
NCT05258630Phase 2Completed
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Diabetes Homeless Medication Support Randomized Pilot Treatment Development Trial (D-Homes)

Hennepin Healthcare Research Institute·interventional·Posted Feb 28, 2022·Updated Nov 7, 2024

In Brief

A Phase 2 clinical trial evaluating Diabetes Homeless Medication Support (D-Homes) and Enhanced usual care for Diabetes Mellitus, Type 2 and 2 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Housing Problems, Psychological Distress
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedFeb 28, 2022
Enrollment StartFeb 23, 2022
Primary CompletionApr 27, 2023
Study CompletionJul 12, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.3 years ago

Interventions

Diabetes Homeless Medication Support (D-Homes)behavioral

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.

Enhanced usual carebehavioral

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).