DH-Spanish: Diabetes Homelessness Medication Support Program in Spanish

Sponsor

Hennepin Healthcare Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05819749

Collaborator

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

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: Diabetes Homelessness Medication Support Program in Spanish	N/A

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). 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-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). We have a hypothesis 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.

Study Design

Study Type:

Interventional

Anticipated 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 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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Expanding the Diabetes Homelessness Medication Support (D-Homes) Program to Spanish Speaking Hispanics

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DH-Spanish Intervention Behavioral treatment by a diabetes wellness coach.	Behavioral: Diabetes Homelessness Medication Support Program in Spanish 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 resources and care coordination. The coach will also provide brief diabetes education as needed. Other Names: DH-Spanish DHomes - Spanish

Arm

Intervention/Treatment

Experimental: DH-Spanish Intervention

Behavioral treatment by a diabetes wellness coach.

Behavioral: Diabetes Homelessness Medication Support Program in Spanish

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 resources and care coordination. The coach will also provide brief diabetes education as needed.

Other Names:

DH-Spanish

DHomes - Spanish

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

Change in glycemic control [Baseline to 16 weeks]
We will measure glycemic control using hemoglobin A1c. This will be done on a consistent, validated point-of-care machine using blood samples collected via venipuncture. We will compare glycemic control from baseline to 16 weeks.
Health-related quality of life [Baseline to 16 weeks]
As measured by the SF-12, a 12-question questionnaire. The SF-12 is analyzed for two summary scores - the physical component score (PCS-12) and the mental component score (MCS-12). The average score of each component is 50 for people in the United States, with a standard deviation of 10 points.
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. We will compare ARMS-D scores from baseline to 16 weeks.

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
Spanish-speaking
Recent homelessness by federal definition (HEARTH ACT)

Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)
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

Contacts and Locations

Locations

No locations specified.

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

Investigators

Principal Investigator: Katherine D Vickery, MD, Hennepin Healthcare Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hennepin Healthcare Research Institute

ClinicalTrials.gov Identifier:

NCT05819749

Other Study ID Numbers:

IRB-FY2023-556
R03DK133553

First Posted:

Apr 19, 2023

Last Update Posted:

Apr 19, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hennepin Healthcare Research Institute

Unstably Housed Persons

Hispanic or Latino

Homelessness

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 19, 2023