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Completed

NCT Number: NCT04678284

Diabetes Homeless Medication Support Single Arm Treatment Development Trial

This single-arm trial of the Diabetes Homeless Medication Support intervention alone (n=15) will test the perception and feasibility of anticipated study procedures.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Homeless Persons 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, 55415, United States

About this study

This study is of a set of studies with 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). Our 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.

This protocol addresses a pilot study to test patient perceptions of the feasibility and acceptability of study procedures and refine the D-Homes treatment manual through test cases (n=15). With a hypothesis that the D-Homes manual and study procedures will be feasible and acceptable to DH 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
  • English-speaking
  • Homelessness by federal definition in the last 12 mo.
  • 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
  • HbA1c >/= 7.5%

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 Homeless Medication Support (D-Homes)

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 resource and care coordination. The coach will also provide brief diabetes education as needed.

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. Hemoglobin A1c

    Time frame: Baseline to 16 weeks

    Change in point-of-care hemoglobin A1c: This test measures average blood sugar over a three month period, and smaller numbers indicate better glycemic control.

  2. Psychological Wellness

    Time frame: Baseline to 16 weeks

    Change in psychological wellness as measured by the Short Form (SF)-12. The SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. Scores range from 20 to 60, and higher score indicate a higher level of functioning.

  3. Diabetes Medication Adherence

    Time frame: Baseline to 12 weeks

    Change in score on Adherence to Refills and Medications Scales-Diabetes (ARMS-D), Total scores range from 12-48, with higher values indicating worse outcomes.

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

Acronym: D-Homes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2020
Registry last updated
Apr 18, 2023

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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