NCT05616026

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
6mo left

Started Feb 2023

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Feb 2023Nov 2026

First Submitted

Initial submission to the registry

November 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

3.8 years

First QC Date

November 4, 2022

Last Update Submit

January 13, 2026

Conditions

Diabetes Mellitus

Keywords

DiabetesHomelessnessSMS textmobile HealthClinical trialHealth disparities

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    Hemoglobin A1c level

    9 months

Secondary Outcomes (2)

  • Proportion of Days Covered (PDC)

    9 months

  • Appointment Adherence

    9 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Behavioral: Attention Control

Interventions

InterventionBEHAVIORAL

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

Also known as: Diabetes SMS text
Intervention
Attention ControlBEHAVIORAL

6 months of texts for general health promotion

Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

George Washington University

Washington D.C., District of Columbia, 20052, United States

RECRUITING

NYU Langone Health

New York, New York, 10003, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Methods

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Ramin Asgary, MD, MPH

CONTACT

917-684-9331raminasgary1@gwu.edu

Leah Bauder, MPH

CONTACT

970-682-0940leahbaud@gwu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Intervention versus Control group; Randomized at the Individual level
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor School oh Public Health, PI

Study Record Dates

First Submitted

November 4, 2022

First Posted

November 14, 2022

Study Start

February 7, 2023

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)