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Diabetes Homeless Medication Support

NCT05258630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-11-07

Study results available
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Summary

This randomized pilot trial of the Diabetes Homeless Medication Support intervention vs. brief diabetes education will test the perception and feasibility of anticipated study procedures and refine randomization and blinding.

Conditions

  • Diabetes Mellitus, Type 2
  • Housing Problems
  • Psychological Distress

Interventions

BEHAVIORAL

Diabetes Homeless Medication Support (D-Homes)

There will be 10 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 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 to the patient's needs/goals and tailored diabetes education as needed.

BEHAVIORAL

Enhanced usual care

Trained diabetes wellness coaches will provide an approximately 15 minutes of instruction about the basic concepts of diabetes. They will use handouts aligned with American Diabetes Association guidelines. They will read 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

  • Hennepin Healthcare Research Institute

    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
2022-02-23
Primary Completion
2023-04-27
Completion
2023-07-12

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05258630 on ClinicalTrials.gov