RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-25
Study Completion:2029-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07091487

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 yrs. or older
  2. 2. English or Spanish-speaking
  3. 3. Recent homelessness by HUD and HHS definitions
  4. 1. Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)
  5. 2. Significant housing instability in the last 24 mos. (includes any stay in shelter, outside, or places not meant for human habitation)
  6. 4. Self-reported diagnosis of type 2 diabetes with A1c \>7.5%, later verified in medical record and study lab. test
  7. 5. Plan to stay in local area or be reachable by phone for the next 12 months
  8. 6. Willingness to work on medication adherence and diabetes self-care
  1. 1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)
  2. 2. Active psychosis or intoxication precluding ability to give informed consent
  3. 3. Pregnant or lactating people at initial enrollment, determined by specific screening questions.

Contacts and Locations

Study Contact

Katherine D Vickery, MD, MSc
CONTACT
6128736852
katherine.vickery@hcmed.org

Principal Investigator

Katherine D Vickery, MD, MSc
PRINCIPAL_INVESTIGATOR
Hennepin Healthcare Research Institute

Study Locations (Sites)

Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55404
United States

Collaborators and Investigators

Sponsor: Katherine Vickery

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-25
Study Completion Date2029-09-30

Study Record Updates

Study Start Date2025-06-25
Study Completion Date2029-09-30

Terms related to this study

Keywords Provided by Researchers

  • Type 2 Diabetes
  • Homelessness
  • Behavioral Activation

Additional Relevant MeSH Terms

  • Type 2 Diabetes