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

Sponsor

Hennepin Healthcare Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04678284

Collaborator

National Institutes of Health (NIH) (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), University of Minnesota (Other)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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

Study Type:

Interventional

Actual Enrollment :

12 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.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

Actual Study Start Date :

Mar 24, 2021

Actual Primary Completion Date :

Mar 24, 2022

Actual Study Completion Date :

Mar 24, 2022

Arms and Interventions

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.

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

Primary Outcome Measures

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

Hemoglobin A1c [Baseline to 16 weeks]
Change in point-of-care hemoglobin A1c
Psychological wellness [Baseline to 16 weeks]
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.
Diabetes medication adherence [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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.