Short-messaging Services (SMS) Text for Uncontrolled Diabetes Among Persons Experiencing Homelessness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- George Washington University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change in HbA1c
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention
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.
Intervention: Intervention (Behavioral)
Control
The control (CL) will receive 6 months of texts for general health promotion.
Intervention: Attention Control (Behavioral)
Outcomes
Primary Outcomes
Change in HbA1c
Time Frame: 9 months
Hemoglobin A1c level
Secondary Outcomes
- Summary of Diabetes Self-Care Activities (SDSCA)(9 months)
- Appointment Adherence(9 months)
- Proportion of Days Covered (PDC)(9 months)
Investigators
Ramin Asgary
Associate Professor School oh Public Health, PI
George Washington University