Completed

D-HOMESCollaborative Care Intervention for Homeless Diabetes Patients Medication Adherence

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Study Aim

This phase 2 study aims to evaluate the acceptability and effectiveness of a collaborative care intervention in improving medication adherence among homeless individuals with diabetes, measuring your satisfaction with the intervention and tracking your participation in post-treatment assessments.

What is being tested

Diabetes Homeless Medication Support (D-Homes)

+ Enhanced usual care

Behavioral
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorHennepin Healthcare Research Institute
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 23, 2022

Actual date on which the first participant was enrolled.

The study focuses on creating and testing a collaborative care approach for people experiencing homelessness and diabetes (DH). This approach combines motivational interviewing, behavioral activation, education, and psychosocial support to enhance medication adherence, tailored specifically to the experiences of this population. The aim is to improve medication adherence and diabetes self-care, which could eventually lead to better blood sugar control and more efficient healthcare use. The study is important as it addresses a unique context, aiming to meet the unmet needs of people experiencing both homelessness and diabetes. In this study, participants will be randomly assigned to either the D-Homes program or a brief diabetes education group. The study will enroll 54 participants and refine procedures for the randomized trial outcome measures. The acceptability of the intervention will be assessed using the Client Satisfaction Questionnaire, an 8-item version, with higher scores indicating greater satisfaction. Additionally, the study team will track the retention of participants who complete both post-treatment assessment visits, at 12-16 weeks and 24-30 weeks post-treatment, measuring retention as the percentage of enrolled participants completing both assessments.

Official TitleDiabetes Homeless Medication Support Randomized Pilot Treatment Development Trial (D-Homes)
NCT05258630
Principal SponsorHennepin Healthcare Research Institute
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

38 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 inclusion criteria required to participate
English-speaking

Age 18 yrs. or older

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.

Show More Criteria

3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Behavioral treatments by a diabetes wellness coach as defined below.

Group II

Active Comparator
Brief diabetes educational session by a diabetes wellness coach.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hennepin Healthcare

Minneapolis, United StatesOpen Hennepin Healthcare in Google Maps
CompletedOne Study Center