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Diabetes Homeless Medication Support Single Arm Treatment Development Trial (D-Homes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04678284
Recruitment Status : Not yet recruiting
First Posted : December 21, 2020
Last Update Posted : December 23, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Minnesota
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Homeless Persons Behavioral: Diabetes Homeless Medication Support (D-Homes) Phase 1 Phase 2

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: Baseline to 16 weeks ]
    Change in point-of-care hemoglobin A1c

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 yrs. or older
  2. English-speaking
  3. Homelessness by federal definition in the last 12 mo.
  4. Self-reported diagnosis of type 2 diabetes, later verified in medical record
  5. Plan to stay in local area or be reachable by phone for the next 16 weeks
  6. Willingness to work on medication adherence and diabetes self-care

Exclusion Criteria:

  1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)
  2. Active psychosis or intoxication precluding ability to give informed consent
  3. Pregnant or lactating females.
  4. Patients who choose to opt out of research.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Katherine D Vickery, MD 6128736852 katherine.vickery@hcmed.org

Sponsors and Collaborators
Hennepin Healthcare Research Institute
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Minnesota
More Information
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Publications of Results:

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Responsible Party: Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT04678284    
Other Study ID Numbers: HHRI-DHomes
K23DK118117 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: As this work will inform treatment development, we will not share individual participant data. We will submit for publication an overall paper describing our results and how they informed future intervention development.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hennepin Healthcare Research Institute:
Type 2 Diabetes
Homeless persons
Delivery of Health Care, Integrated
Primary care
Social determinants of health
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases