Diabetes Homelessness Medication Support Program in Spanish

Diabetes Mellitus, Type 2 Clinical Trial

— DH-Spanish  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05819749
• Other study ID #: IRB-FY2023-556
• Secondary ID: R03DK133553
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: April 2024
• 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 for Spanish-speaking people (n=12) will test the perception and feasibility of anticipated study procedures.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 28, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 yrs or older
• Spanish-speaking
• Recent homelessness by federal definition (HEARTH ACT)

1. Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)

2. 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Diabetes Homelessness Medication Support Program in Spanish
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.

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)

Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66. doi: 10.1023/a:1008809610703. — 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 Se — 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	Change in glycemic control	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.	Baseline to 16 weeks
Secondary	Health-related quality of life	As measured by the 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.	Baseline to 16 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. We will compare ARMS-D scores from baseline to 16 weeks.	Baseline to 16 weeks