Diabetes Homelessness Medication Support Program in Spanish
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Diabetes Homelessness Medication Support Program in Spanish
- Registration Number
- NCT05819749
- Lead Sponsor
- Hennepin Healthcare Research Institute
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
-
Age 18 yrs or older
-
Spanish-speaking
-
Recent homelessness by federal definition (HEARTH ACT)
- Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DH-Spanish Intervention Diabetes Homelessness Medication Support Program in Spanish Behavioral treatment by a diabetes wellness coach.
- 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 Change in Glycemic Control Baseline and 16 weeks 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.
Health-related Quality of Life Baseline and 16 weeks As measured by the 12 Item Short Form Survey (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. Scores above 50 indicate higher than average health-related quality of life while scores below 50 indicate lower than average health-related quality of life.
Diabetes Medication Adherence Baseline and 16 weeks 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.
Trial Locations
- Locations (1)
Hennepin Healthcare
🇺🇸Minneapolis, Minnesota, United States