Diabetes Homeless Medication Support Single Arm Treatment Development Trial (D-Homes)
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|ClinicalTrials.gov Identifier: NCT04678284|
Recruitment Status : Not yet recruiting
First Posted : December 21, 2020
Last Update Posted : December 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Homeless Persons||Behavioral: Diabetes Homeless Medication Support (D-Homes)||Phase 1 Phase 2|
This study is part 2 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 work builds upon part 1 during which we completed Aim 1 activities to develop the initial Diabetes Homeless Medication Support (D-Homes) treatment manual through focus groups with DH at various levels of glycemic control and interviews with their multi-disciplinary providers. Data from this phase has identified barriers and strategies for medication adherence, patient values regarding medication, and treatment preferences and informed development of this part 2 application.
This protocol addresses Aim 2, 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Diabetes Homeless Medication Support Single Arm Treatment Development Trial|
|Estimated Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||August 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: D-Homes intervention
Behavioral treatments by a diabetes wellness coach as defined below.
Behavioral: Diabetes Homeless Medication Support (D-Homes)
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.
- Acceptability of intervention [ Time Frame: at 16 weeks ]Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.
- Hemoglobin A1c [ Time Frame: Baseline to 16 weeks ]Change in point-of-care hemoglobin A1c
- Health-related quality of life [ Time Frame: Baseline to 16 weeks ]Health related quality of life as measured by the Euro-Qol-5, 3-level. Scores in the index portion range of 5 to 15 with low score indicating low functional impairment. The visual analogue scale portion ranges from 0 to 100 with lower values indicating worse health. Both will be used in this study.
- Diabetes medication adherence [ Time Frame: Baseline to 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678284
|Contact: Katherine D Vickery, MDemail@example.com|