Diabetes Mellitus, Type 2 Clinical Trial
— DH-SpanishOfficial title:
Expanding the Diabetes Homelessness Medication Support (D-Homes) Program to Spanish Speaking Hispanics
Verified date | April 2024 |
Source | Hennepin Healthcare Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Hennepin Healthcare | Minneapolis | Minnesota |
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 |
United States,
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
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 |
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