Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management

Summary

The goal of this clinical trial is to learn if the Diabetes Homelessness Medication Support (D-HOMES) wellness coaching model is effective for adults who speak English or Spanish, have Type 2 diabetes with an HbA1c at or above 7.5, and have recently experienced homelessness. Researchers will compare a one-time education session about diabetes to 10 wellness coaching sessions to see if there are differences between the groups' health outcomes. The main questions it aims to answer are:

* Do D-HOMES participants have greater reductions in HbA1c at 3 months than participants who received education?
* Do D-HOMES participants have greater reductions in HbA1c at 6 and 12 months compared to those who received education?
* Do D-HOMES participants have improvements in blood pressure control, quality of life, self-reported psychological wellness, diabetes distress, and diabetes medication adherence and self-management at 3, 6, and 12 months?
* What factors must be considered to make D-HOMES scalable?

Participants will:

* complete 5 assessments including two baseline assessments and follow-ups at months 3,6, and 12
* participate in a one-time education session or 10 weeks of wellness coaching.

Conditions

• Type 2 Diabetes

Interventions

BEHAVIORAL

Diabetes Homeless Medication Support

There will be 10 one-on-one 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 and psychologiccal wellness 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 matched to the patient's needs/goals and tailored diabetes education as needed.

BEHAVIORAL

Enhanced Usual Care/ Education

Trained diabetes wellness coaches will provide approximately 15 minutes of instruction about the basic concepts of diabetes. They will use handouts aligned with American Diabetes Association guidelines. They will use the ask-offer-ask method to review 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).

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Katherine Vickery

  lead OTHER

Principal Investigators

• Katherine D Vickery, MD, MSc · Hennepin Healthcare Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-25

Primary Completion

2028-12-30

Completion

2029-09-30

Countries

• United States

Study Locations