Diabetes Homeless Medication Support Single Arm Treatment Development Trial

Type 2 Diabetes Clinical Trial

— D-Homes  

Official title:

Diabetes Homeless Medication Support Single Arm Treatment Development Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678284
• Other study ID #: HHRI-DHomes
• Secondary ID: K23DK118117
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: March 24, 2022

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• 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 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Homeless Persons
• Type 2 Diabetes

Intervention

Behavioral:
• Diabetes Homeless Medication Support (D-Homes)
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.

Locations

Country	Name	City	State
United States	Hennepin Healthcare	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (3)

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. — View Citation

Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26. — View Citation

Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. doi: 10.1016/0149-7189(83)90010-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of Intervention	Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.	at 16 weeks
Secondary	Hemoglobin A1c	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.	Baseline to 16 weeks
Secondary	Psychological Wellness	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.	Baseline to 16 weeks
Secondary	Diabetes Medication Adherence	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.	Baseline to 12 weeks