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Diabetes Homelessness Medication Support Program in Spanish (DH-Spanish)

Hennepin Healthcare logo

Hennepin Healthcare

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Behavioral: Diabetes Homelessness Medication Support Program in Spanish

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05819749
R03DK133553 (U.S. NIH Grant/Contract)
IRB-FY2023-556

Details and patient eligibility

About

This single-arm trial of the Diabetes Homeless Medication Support intervention for Spanish-speaking people (n=12) will test the perception and feasibility of anticipated study procedures.

Full description

This study has an overall goal to modify and pilot test a previously developed 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 intervention was developed in English. This study is intended to test the modified intervention for DH who speak Spanish (DH-SH). The study team's 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-SH.

This protocol tests patient perceptions of the feasibility and acceptability of study procedures and refines the D-Homes treatment manual through test cases (n=12). The study team hypothesizes that the D-Homes manual and study procedures will be feasible and acceptable to DH-SH as measured by self-report and post-treatment interview.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 yrs or older

  • Spanish-speaking

  • Recent homelessness by federal definition (HEARTH ACT)

    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)
  • Self-reported diagnosis of type 2 diabetes, later verified in medical record

  • Plan to stay in local area or be reachable by phone for the next 16 weeks

  • Willingness to work on medication adherence and diabetes self-care

Exclusion criteria

  • Inability to provide informed consent (e.g. presence of a legal guardian, prisoners)
  • Active psychosis or intoxication precluding ability to give informed consent
  • Pregnant or lactating females
  • Patients who choose to opt out of research

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

DH-Spanish Intervention
Experimental group
Description:
Behavioral treatment by a diabetes wellness coach.
Treatment:
Behavioral: Diabetes Homelessness Medication Support Program in Spanish

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Katherine D Vickery, MD

Data sourced from clinicaltrials.gov

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