Diabetes Homeless Medication Support Single Arm Treatment Development Trial

Study Overview
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Brief Summary
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This single-arm trial of the Diabetes Homeless Medication Support intervention alone (n=15) will test the perception and feasibility of anticipated study procedures.

Detailed Description
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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.

Official Title
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Diabetes Homeless Medication Support Single Arm Treatment Development Trial

Conditions
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Homeless Persons, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Diabetes Homeless Medication Support (D-Homes)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 yrs. or older English-speaking Homelessness by federal definition in the last 12 mo. 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 HbA1c >/= 7.5% 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 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: D-Homes intervention<br>Behavioral treatments by a diabetes wellness coach as defined below. | Behavioral: Diabetes Homeless Medication Support (D-Homes)<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 resource and care coordination. The coach will also provide brief diabetes education as needed.<br>|

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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Homeless persons, Delivery of Health Care, Integrated, Primary care, Social determinants of health