Diabetes Homelessness Medication Support Program in Spanish

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Diabetes Homelessness Medication Support Program in Spanish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This will be an in-person, phone, or video based behavioral intervention. It will involve a diabetes wellness coach assisting participants to use behavioral activation and motivational interviewing to set goals related to diabetes self-care and co-morbidities or social conditions that get in the way of diabetes self-care. There will be encouragement to work on diabetes medication adherence and to address any un/under-treated behavioral health conditions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DH-Spanish Intervention<br>Behavioral treatment by a diabetes wellness coach. | Behavioral: Diabetes Homelessness Medication Support Program in Spanish<br>* 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.<br>* Other names: DHomes - Spanish;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unstably Housed Persons, Hispanic or Latino, Homelessness