Clinical trial NCT05819749: Diabetes Homelessness Medication Support Program in Spanish
Official title: Expanding the Diabetes Homelessness Medication Support (D-Homes) Program to Spanish Speaking Hispanics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Unstably Housed Persons
Hispanic or Latino
Homelessness
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Minnesota
First posted: 2023-04-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 use behavioral activation and motivational interviewing 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.
Primary purpose: TREATMENT

Brief summary: This single-arm trial of the Diabetes Homeless Medication Support intervention for Spanish-speaking people (n=12) will test the perception and feasibility of anticipated study procedures.

Detailed description: This study has an overall goal to modify and pilot test a previously developed 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). The intervention was developed in English. This study is intended to test the modified intervention for DH who speak Spanish (DH-SH). The study 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-SH.

This protocol tests patient perceptions of the feasibility and acceptability of study procedures and refines the D-Homes treatment manual through test cases (n=12). The study team hypothesizes that the D-Homes manual and study procedures will be feasible and acceptable to DH-SH as measured by self-report and post-treatment interview.

Eligibility criteria: Inclusion Criteria:

* Age 18 yrs or older
* Spanish-speaking
* Recent homelessness by federal definition (HEARTH ACT)

  1. Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)
  2. Significant housing instability in the last 24 mos. (includes any stay in shelter, outside, or places not meant for human habitation)
* 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

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: at 16 weeks
Secondary outcomes:
measure: Change in Glycemic Control
timeFrame: Baseline and 16 weeks
measure: Health-related Quality of Life
timeFrame: Baseline and 16 weeks
measure: Diabetes Medication Adherence
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Katherine D Vickery, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26.
citation: Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66. doi: 10.1023/a:1008809610703.
citation: Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. doi: 10.1016/0149-7189(83)90010-1.