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Diabetes Homeless Medication Support (D-HOMES)

H

Hennepin Healthcare

Status and phase

Completed
Phase 2

Conditions

Housing Problems
Diabetes Mellitus, Type 2
Psychological Distress

Treatments

Behavioral: Diabetes Homeless Medication Support (D-Homes)
Behavioral: Enhanced usual care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05258630
IRB-FY2021-317
K23DK118117 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This study has an overall goal to develop and pilot test a collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and diabetes (DH). The investigators' central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of DH.

This study will involve addition of a randomization schema to compare D-Homes to brief diabetes education. The study team will enroll participants (n=54), and refine procedures for the randomized trial outcome measures. This includes an assessment of sustained impact of the program at 24-weeks post-treatment. These will complement 12-week post-treatment primary outcome measures.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age 18 yrs. or older
  2. English-speaking
  3. Homelessness by federal definition (HEARTH ACT) in the past 24 mos.
  4. Self-reported diagnosis of type 2 diabetes with A1c >7.5%, later verified in medical record and study point-of-care lab test.
  5. Plan to stay in local area or be reachable by phone for the next 24 weeks
  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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

38 participants in 2 patient groups

D-Homes intervention
Experimental group
Description:
Behavioral treatments by a diabetes wellness coach as defined below.
Treatment:
Behavioral: Enhanced usual care
Behavioral: Diabetes Homeless Medication Support (D-Homes)
Enhanced usual care
Active Comparator group
Description:
Brief diabetes educational session by a diabetes wellness coach.
Treatment:
Behavioral: Enhanced usual care

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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