Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management (D-HOMES R01)

Katherine Vickery

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Enhanced Usual Care/ Education; Behavioral: Diabetes Homeless Medication Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07091487

IRB-FY2024-849

R01DK139152 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 yrs. or older

2. English or Spanish-speaking

3. Recent homelessness by HUD and HHS definitions

   1. Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)
   2. Significant housing instability in the last 24 mos. (includes any stay in shelter, outside, or places not meant for human habitation)

4. Self-reported diagnosis of type 2 diabetes with A1c >7.5%, later verified in medical record and study lab. test

5. Plan to stay in local area or be reachable by phone for the next 12 months

6. Willingness to work on medication adherence and diabetes self-care

Exclusion criteria

1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)
2. Active psychosis or intoxication precluding ability to give informed consent
3. Pregnant or lactating people at initial enrollment, determined by specific screening questions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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256 participants in 2 patient groups

Enhanced Usual Care/Education Session

Active Comparator group

Description:

Brief one-on-one diabetes education session provided by a diabetes wellness coach.

Treatment:

Behavioral: Enhanced Usual Care/ Education

Diabetes Homeless Medication Support (D-HOMES)

Experimental group

Description:

10 one-on-one behavioral treatments by a diabetes wellness coach.

Treatment:

Behavioral: Diabetes Homeless Medication Support