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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Katherine Vickery
Study ID
NCT07091487
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diabetes Homeless Medication Support — BEHAVIORAL
    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.
  • Enhanced Usual Care/ Education — BEHAVIORAL
    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).

Study Details

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.

Key Dates

Start date
Jun 25, 2025
Status verified
Jul 2025
Primary completion
Dec 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Enhanced Usual Care/Education Session
    Brief one-on-one diabetes education session provided by a diabetes wellness coach.
  • Experimental: Diabetes Homeless Medication Support (D-HOMES)
    10 one-on-one behavioral treatments by a diabetes wellness coach.

Primary Outcome Measure

Change in HbA1c at 3 months [ Time Frame: From Baseline 1 to Month 3 assessment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hennepin Healthcare Research InstituteMinneapolisMinnesota55404
Katherine D Vickery, MD, MSc
[email protected]
612-873-6852
Katherine D Vickery, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Minneapolis, MN

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Hennepin Healthcare Research Institute· Minneapolis, MN

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