Texts for Diabetes Control Among Homeless Persons

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Intervention
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention versus Control group; Randomized at the Individual level
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Intervention<br>* 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<br>* Other names: Diabetes SMS text;|
| Placebo Comparator: Control<br>The control (CL) will receive 6 months of texts for general health promotion. | Behavioral: Attention Control<br>* 6 months of texts for general health promotion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Hemoglobin A1c level | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Diabetes Self-Care Activities (SDSCA) | Summary of Diabetes Self-Care Activities | 9 months | 
| Proportion of Days Covered (PDC) | Medication Adherence through Proportion of Days Covered of Medications | 9 months | 
| Appointment Adherence | Proportion of appointment adherence | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Homelessness, SMS text, mobile Health, Clinical trial, Health disparities