Recruiting

D-HOMES & Education

Sponsor:

Katherine Vickery

Code:

NCT07091487

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diabetes Homeless Medication Support

Enhanced Usual Care/ Education

Study Details

Brief 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

Study ID

NCT07091487

Start date

Jun 25, 2025

Status verified date

Jul, 2025

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Katherine D Vickery, MD, MSc

6128736852katherine.vickery@hcmed.org

Locations

Hennepin Healthcare Research Institute

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Katherine D Vickery, MD, MSc

612-873-6852katherine.vickery@hcmed.org

Principal Investigator:

Katherine D Vickery, MD, MSc

More Information

Sponsor

Katherine Vickery

Last update posted

Jul 29, 2025

Last verified

Jul, 2025

Keywords

  • Type 2 Diabetes
  • Homelessness
  • Behavioral Activation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Katherine Vickery on 2025-07-29.