Diabetes Homelessness Medication Support Program in Spanish

NCT ID: NCT05819749

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-07-12

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DH-Spanish Intervention

Behavioral treatment by a diabetes wellness coach.

Group Type: EXPERIMENTAL

Diabetes Homelessness Medication Support Program in Spanish

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

DH-Spanish; DHomes - Spanish

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Hennepin Healthcare Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine D Vickery, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin Healthcare Research Institute

Locations

Hennepin Healthcare

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24209600 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9523497 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10267258 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R03DK133553

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-FY2023-556

Identifier Type: -

Identifier Source: org_study_id