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Completed

NCT Number: NCT05819749

Diabetes Homelessness Medication Support Program in Spanish

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin Healthcare

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 yrs or older
  • Spanish-speaking
  • Recent homelessness by federal definition (HEARTH ACT)
  • Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)
  • 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

Treatment and study plan

Diabetes Homelessness Medication Support Program in Spanish

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Glycemic Control

    Time frame: Baseline 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.

  2. Health-related Quality of Life

    Time frame: Baseline 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.

  3. Diabetes Medication Adherence

    Time frame: Baseline 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.

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DH-Spanish

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2023
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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