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

April 3, 2024 updated by: Hennepin Healthcare Research Institute

Expanding the Diabetes Homelessness Medication Support (D-Homes) Program to Spanish Speaking Hispanics

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Hennepin Healthcare

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DH-Spanish Intervention
Behavioral treatment by a diabetes wellness coach.
Behavioral: Diabetes Homelessness Medication Support Program in Spanish
There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 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 resources and care coordination. The coach will also provide brief diabetes education as needed.
Other Names:
  • DH-Spanish
  • DHomes - Spanish

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of intervention
Time Frame: at 16 weeks
Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
at 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycemic control
Time Frame: Baseline to 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.
Baseline to 16 weeks
Health-related quality of life
Time Frame: Baseline to 16 weeks
As measured by the 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.
Baseline to 16 weeks
Diabetes medication adherence
Time Frame: Baseline to 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.
Baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
University of Minnesota

Investigators

  • Principal Investigator: Katherine D Vickery, MD, Hennepin Healthcare Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

February 22, 2024

Study Completion (Estimated)

June 28, 2024

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Diabetes Homelessness Medication Support Program in Spanish

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe