NCT03178773

Brief Summary

This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline
Completed

Started Jul 2017

Typical duration for phase_2 diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 18, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 6, 2021

Completed
Last Updated

August 6, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

June 5, 2017

Results QC Date

July 6, 2020

Last Update Submit

July 14, 2021

Conditions

Diabetes

Keywords

mobile healthsocial supporthealth disparityLatino

Outcome Measures

Primary Outcomes (1)

  • Change in HBA1c From Baseline

    Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is baseline value minus follow up value.

    6 Months

Secondary Outcomes (34)

  • Change in HBA1c From 6 Months to 12 Months

    12 months

  • Change in BMI From Baseline

    6 Months

  • Change in BMI From 6 Months to 12 Months

    12 Months

  • Change in Abdominal Circumference From Baseline

    6 Months

  • Change From Abdominal Circumference From 6 Months to 12 Months

    12 Months

  • +29 more secondary outcomes

Study Arms (2)

TExT-MED only

ACTIVE COMPARATOR

Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.

Behavioral: TExT-MED

TExT-MED+FANS

EXPERIMENTAL

Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.

Behavioral: TExT-MEDBehavioral: FANS

Interventions

TExT-MEDBEHAVIORAL

messages designed to inspire motivation and behavior change

TExT-MED onlyTExT-MED+FANS
FANSBEHAVIORAL

SMS delivered messages to family members to improve social support

TExT-MED+FANS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • HbA1c\>8.5
  • Social support person identified and contacted

You may not qualify if:

  • unable to consent
  • does not speak/read English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAC+USC Medicine Center Emergency Department

Los Angeles, California, 90033, United States

Location

Related Publications (1)

  • Burner E, Hazime D, Menchine M, Mack W, Mercado J, Aleman A, Hernandez Saenz A, Arora S, Wu S. mHealth Social Support Versus Standard Support for Diabetes Management in Safety-Net Emergency Department Patients: Randomized Phase-III Trial. JMIR Diabetes. 2025 Apr 23;10:e56934. doi: 10.2196/56934.

    PMID: 40266665DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Follow up rates were lower than anticipated

Results Point of Contact

Title
Elizabeth Burner
Organization
University of Southern California
eburner@usc.edu
3234096667

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Emergency Medicine

Study Record Dates

First Submitted

June 5, 2017

First Posted

June 7, 2017

Study Start

July 18, 2017

Primary Completion

December 2, 2019

Study Completion

December 2, 2019

Last Updated

August 6, 2021

Results First Posted

August 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)