Diabetes Homeless Medication Support

Diabetes Mellitus, Type 2 Clinical Trial

— D-HOMES  

Official title:

Diabetes Homeless Medication Support Randomized Pilot Treatment Development Trial (D-Homes)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05258630
• Other study ID #: IRB-FY2021-317
• Secondary ID: K23DK118117
• Status: Completed
• Phase: Phase 2
• Start date: February 23, 2022
• Est. completion date: July 12, 2023

Study information

• Verified date: November 2023
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized pilot trial of the Diabetes Homeless Medication Support intervention vs. brief diabetes education will test the perception and feasibility of anticipated study procedures and refine randomization and blinding.

Description:

This study has 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). The investigators' 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 study will involve addition of a randomization schema to compare D-Homes to brief diabetes education. The study team will enroll participants (n=54), and refine procedures for the randomized trial outcome measures. This includes an assessment of sustained impact of the program at 24-weeks post-treatment. These will complement 12-week post-treatment primary outcome measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 12, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 yrs. or older

2. English-speaking

3. Homelessness by federal definition (HEARTH ACT) in the past 24 mos.

4. Self-reported diagnosis of type 2 diabetes with A1c >7.5%, later verified in medical record and study point-of-care lab test.

5. Plan to stay in local area or be reachable by phone for the next 24 weeks

6. Willingness to work on medication adherence and diabetes self-care

Exclusion Criteria:

1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)

2. Active psychosis or intoxication precluding ability to give informed consent

3. Pregnant or lactating people

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Housing Problems
• Psychological Distress

Intervention

Behavioral:
• Diabetes Homeless Medication Support (D-Homes)
There will be 10 sessions offered within 12 weeks to participants. Sessions will last approximately 30 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 a tailored tool to the patient's needs/goals and tailored diabetes education as needed.
• Enhanced usual care
Trained diabetes wellness coaches will provide an approximately 15 minutes of instruction about the basic concepts of diabetes. They will use handouts aligned with American Diabetes Association guidelines. They will read these with participants and answer basic questions. Handouts will cover (1) general diabetes knowledge, (2) healthy eating with diabetes, (3) physical activity with diabetes. The coach will also provide a general tool to support medication adherence (e.g. pillbox).

Locations

Country	Name	City	State
United States	Hennepin Healthcare	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experience during the intervention	The acceptability of the intervention to participants will be measured by the Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.	Baseline to 16 weeks
Primary	Retention in assessments	The study team will track enrolled participants who complete post-treatment assessment visits. They have planned one 12-16 week post-treatment assessment and a second 24-30 week assessment. Retention will be measured as the percentage of enrolled participants who complete each of these assessments.	Baseline to 30 weeks
Secondary	Change in glycemic control	The study team will measure glycemic control using hemoglobin A1c. This will be done on a consistent, validated point-of-care machine using fingerstick blood samples. The study team will compare glycemic control from baseline to 16 weeks and from baseline to 30 weeks.	Baseline to 30 weeks
Secondary	Psychological wellness	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. We will compare SF-12 scores from baseline to 16 weeks and from baseline to 30 weeks.	Baseline to 30 weeks
Secondary	Diabetes medication adherence	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. The study team will compare ARMS-D scores from baseline to 16 weeks and baseline to 30 weeks.	Baseline to 30 weeks