Diabetes Homelessness Medication Support Program in Spanish

NCT05819749 | Completed Results

• 2 other identifiers: IRB-FY2023-556R03DK133553
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Unstably Housed Persons; Hispanic or Latino; Homelessness

Outcome Measures

Primary Outcomes (1)

• Acceptability of Intervention

  Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.

  at 16 weeks

Secondary Outcomes (3)

• Change in Glycemic Control

  Baseline and 16 weeks

• Health-related Quality of Life

  Baseline and 16 weeks

• Diabetes Medication Adherence

  Baseline and 16 weeks

Study Arms (1)

DH-Spanish Intervention

EXPERIMENTAL

Behavioral treatment by a diabetes wellness coach.

Behavioral: Diabetes Homelessness Medication Support Program in Spanish

Interventions

Diabetes Homelessness Medication Support Program in Spanish 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.

Also known as: DH-Spanish, DHomes - Spanish

DH-Spanish Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Minnesota: collaborator

Study Sites (1)

Hennepin Healthcare

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (3)

• 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.

  PMID: 24209600 BACKGROUND

• 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.

  PMID: 9523497 BACKGROUND

• 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.

  PMID: 10267258 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Katherine Diaz Vickery
• Organization: Hennepin Healthcare Research Institute

katherine.vickery@hcmed.org

612-873-6852

Study Officials

• Katherine D Vickery, MD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: May 1, 2023
• Primary Completion: February 22, 2024
• Study Completion: July 12, 2024
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)