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Diabetes Homelessness Medication Support Program in Spanish

Not Applicable
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Behavioral: Diabetes Homelessness Medication Support Program in Spanish
Registration Number
NCT05819749
Lead Sponsor
Hennepin Healthcare Research Institute
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
DH-Spanish InterventionDiabetes Homelessness Medication Support Program in SpanishBehavioral treatment by a diabetes wellness coach.
Primary Outcome Measures
NameTimeMethod
Acceptability of Interventionat 16 weeks

Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.

Secondary Outcome Measures
NameTimeMethod
Change in Glycemic ControlBaseline and 16 weeks

We will measure glycemic control using hemoglobin A1c. This will be done on a consistent, validated point-of-care machine using blood samples collected via venipuncture. We will compare glycemic control from baseline to 16 weeks.

Health-related Quality of LifeBaseline and 16 weeks

As measured by the 12 Item Short Form Survey (SF-12), a 12-question questionnaire. The SF-12 is analyzed for two summary scores - the physical component score (PCS-12) and the mental component score (MCS-12). The average score of each component is 50 for people in the United States, with a standard deviation of 10 points. Scores above 50 indicate higher than average health-related quality of life while scores below 50 indicate lower than average health-related quality of life.

Diabetes Medication AdherenceBaseline and 16 weeks

As measured by the Adherence to Refills and Medications Scales-Diabetes (ARMS-D), Total scores range from 12-48, with higher values indicating worse outcomes. We will compare ARMS-D scores from baseline to 16 weeks.

Trial Locations

Locations (1)

Hennepin Healthcare

🇺🇸

Minneapolis, Minnesota, United States

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