Diabetes Homeless Medication Support Single Arm Treatment Development Trial

NCT04678284 | Completed Results

• 2 other identifiers: HHRI-DHomesK23DK118117
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes; Homeless Persons

Keywords

Type 2 Diabetes; Homeless persons; Delivery of Health Care, Integrated; Primary care; Social determinants of health

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)

• Hemoglobin A1c

  Baseline to 16 weeks

• Psychological Wellness

  Baseline to 16 weeks

• Diabetes Medication Adherence

  Baseline to 12 weeks

Study Arms (1)

D-Homes intervention

EXPERIMENTAL

Behavioral treatments by a diabetes wellness coach as defined below.

Behavioral: Diabetes Homeless Medication Support (D-Homes)

Interventions

Diabetes Homeless Medication Support (D-Homes) 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 resource and care coordination. The coach will also provide brief diabetes education as needed.

D-Homes 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
• English-speaking
• Homelessness by federal definition in the last 12 mo.
• 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
• HbA1c \>/= 7.5%

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, 55415, United States

Location

Related Publications (3)

• 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

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 BACKGROUND

• 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

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: Dr. Katherine Diaz Vickery
• Organization: Hennepin Healthcare

katherine.vickery@hcmed.org

612-873-6852

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 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: December 17, 2020
• First Posted: December 21, 2020
• Study Start: March 24, 2021
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)