Texts for Diabetes Control Among Homeless Persons

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus

• Registration Number: NCT05616026
• Lead Sponsor: George Washington University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-14
• Study Start: 2023-02-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-11-10
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	9 months	Hemoglobin A1c level

Secondary Outcome Measures

Name	Time	Method
Summary of Diabetes Self-Care Activities (SDSCA)	9 months	Summary of Diabetes Self-Care Activities
Appointment Adherence	9 months	Proportion of appointment adherence
Proportion of Days Covered (PDC)	9 months	Medication Adherence through Proportion of Days Covered of Medications

Trial Locations

Locations (2)

George Washington University; 🇺🇸 Washington, District of Columbia, United States

NYU Langone Health; 🇺🇸 New York City, New York, United States