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NCT Number: NCT05616026

Texts for Diabetes Control Among Homeless Persons

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

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

Other names: Diabetes SMS text

Attention Control

Behavioral

6 months of texts for general health promotion

Primary outcomes

  1. Change in HbA1c

    Time frame: 9 months

    Hemoglobin A1c level

Secondary outcomes

  1. Proportion of Days Covered (PDC)

    Time frame: 9 months

    Medication Adherence through Proportion of Days Covered of Medications

  2. Appointment Adherence

    Time frame: 9 months

    Proportion of appointment adherence

Study contacts

Contact information is provided by the study sponsor or research team.

Leah Bauder, MPH

CONTACT

[email protected]

970-682-0940

Ramin Asgary, MD, MPH

CONTACT

[email protected]

917-684-9331

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • NYU Langone Health

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2022
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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