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

Hennepin Healthcare

Status: Completed

Conditions: Homeless Persons; Type 2 Diabetes

Treatments: Behavioral: Diabetes Homeless Medication Support (D-Homes)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04678284

K23DK118117 (U.S. NIH Grant/Contract)

HHRI-DHomes

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
7. HbA1c >/= 7.5%

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

D-Homes intervention

Experimental group

Description:

Behavioral treatments by a diabetes wellness coach as defined below.

Treatment:

Behavioral: Diabetes Homeless Medication Support (D-Homes)