Diabetes Mellitus
Conditions
Keywords
Diabetes, Homelessness, SMS text, mobile Health, Clinical trial, Health disparities
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.
Interventions
BEHAVIORALIntervention
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
BEHAVIORALAttention Control
6 months of texts for general health promotion
Sponsors
NYU Langone Health
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Intervention versus Control group; Randomized at the Individual level
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 9 months | Hemoglobin A1c level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Days Covered (PDC) | 9 months | Medication Adherence through Proportion of Days Covered of Medications |
| Appointment Adherence | 9 months | Proportion of appointment adherence |
Countries
United States
Contacts
Primary ContactRamin Asgary, MD, MPH
Backup ContactLeah Bauder, MPH
Outcome results
None listed