Texts for Diabetes Control Among Homeless Persons

George Washington University (GW)

Status: Enrolling

Conditions: Diabetes Mellitus

Treatments: Behavioral: Attention Control; Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05616026

#11-21-ICTSHD-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

The intervention (INT) will include 6 months of DM management support via SMS texts including reminders for medication adherence, appointments, and DM self-care activities as well as education, and support.

Treatment:

Behavioral: Intervention

Control

Placebo Comparator group

Description:

The control (CL) will receive 6 months of texts for general health promotion.

Treatment:

Behavioral: Attention Control