Texts for Diabetes Control Among Homeless Persons

NCT ID: NCT05616026

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-07

Study Completion Date

2025-11-15

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.

Conditions

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Diabetes Mellitus

Keywords

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Diabetes Homelessness SMS text mobile Health Clinical trial Health disparities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention versus Control group; Randomized at the Individual level
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention

Intervention Type 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

Control

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

Group Type PLACEBO_COMPARATOR

Attention Control

Intervention Type BEHAVIORAL

6 months of texts for general health promotion

Interventions

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Intervention

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

Intervention Type BEHAVIORAL

Attention Control

6 months of texts for general health promotion

Intervention Type BEHAVIORAL

Other Intervention Names

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Diabetes SMS text

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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George Washington University

OTHER

Sponsor Role lead

NYU Langone Health

OTHER

Sponsor Role collaborator

Responsible Party

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Ramin Asgary

Associate Professor School oh Public Health, PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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George Washington University

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

Site Status RECRUITING

NYU Langone Health

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Ramin Asgary, MD, MPH

Role: CONTACT

Phone: 917-684-9331

Email: [email protected]

Leah Bauder, MPH

Role: CONTACT

Phone: 970-682-0940

Email: [email protected]

Facility Contacts

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Ramin Asgary, MD

Role: primary

Leah Bauder, MPH

Role: backup

Other Identifiers

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#11-21-ICTSHD-16

Identifier Type: -

Identifier Source: org_study_id