Diabetes Homeless Medication Support Single Arm Treatment Development Trial

Not Applicable

Completed

• Conditions: Homeless Persons; Type 2 Diabetes
• Interventions: Behavioral: Diabetes Homeless Medication Support (D-Homes)

• Registration Number: NCT04678284
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-21
• Study Start: 2021-03-24
• Primary Completion: 2022-03-24
• Study Completion: 2022-03-24
• Results First Submitted: 2023-03-20
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-17
• Last Update Submitted: 2023-04-17
• Results First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Age 18 yrs. or older
2. English-speaking
3. Homelessness by federal definition in the last 12 mo.
4. Self-reported diagnosis of type 2 diabetes, later verified in medical record
5. Plan to stay in local area or be reachable by phone for the next 16 weeks
6. Willingness to work on medication adherence and diabetes self-care
7. HbA1c >/= 7.5%

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 females.
4. Patients who choose to opt out of research.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D-Homes intervention	Diabetes Homeless Medication Support (D-Homes)	Behavioral treatments by a diabetes wellness coach as defined below.

Primary Outcome Measures

Name	Time	Method
Acceptability of Intervention	at 16 weeks	Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.

Secondary Outcome Measures

Name	Time	Method
Diabetes Medication Adherence	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.
Hemoglobin A1c	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.
Psychological Wellness	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.

Trial Locations

Locations (1)

Hennepin Healthcare; 🇺🇸 Minneapolis, Minnesota, United States