Texts for Diabetes Control Among Homeless Persons

Diabetes Mellitus Clinical Trial

Official title:

Short-messaging Services (SMS) Text for Uncontrolled Diabetes Among Persons Experiencing Homelessness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05616026
• Other study ID #: #11-21-ICTSHD-16
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: January 2024
• Source: George Washington University
• Contact: Ramin Asgary, MD, MPH
• Phone: 917-684-9331
• Email: raminasgary1[@]gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness.

Description:

Diabetes mellitus (DM) is common among persons experiencing homelessness (PEH), often inadequately managed, and carries significant costs. SMS strategies for DM have not been tested among PEH despite the accessibility of mobile phones. This study uses a SMS strategy to offer better communication, education, and information management; improve outreach; facilitate care coordination; explore barriers to care; and support behavior changes. This mixed-methods (RCT and qualitative) study will be implemented in shelter-clinics in New York City in collaboration with community organizations, allowing for sustainability and scalability. Aim 1 will evaluate the efficacy of a 6-month SMS program for DM management versus an attention control on changes in HbA1c and adherence to DM self-care activities, medications, and appointments at 9 months in adult PEH with uncontrolled DM (n=100). Outcomes will be measured at 0, 3, 6, &9 months. Aim 2 will assess patients' and providers' attitudes, acceptability, and experience of the program through semi-structured interviews with PEH and providers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 15, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Homeless person age = 21

• Diagnosed with type 2 DM

• Most recent visit HbA1c = 8%

• English/Spanish speaking

• Connected to study sites' shelter-clinics for care

Exclusion Criteria:

• Pregnant or within 3 months postpartum

• Has an uncontrolled severe illness

• Has had a heart attack or stroke in the previous 6 months

• Inability to read/respond to texts

• Inability to provide informed consent

• Receiving inpatient care for severe substance abuse

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Intervention
6 months of diabetes management support via SMS texts including reminders for medication adherence, appointments, and diabetes self-care activities as well as education, and support
• Attention Control
6 months of texts for general health promotion

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York
United States	George Washington University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Hemoglobin A1c level	9 months
Secondary	Summary of Diabetes Self-Care Activities (SDSCA)	Summary of Diabetes Self-Care Activities	9 months
Secondary	Proportion of Days Covered (PDC)	Medication Adherence through Proportion of Days Covered of Medications	9 months
Secondary	Appointment Adherence	Proportion of appointment adherence	9 months