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Smartphone Application

Telemedicine for Burns (TOBI Trial)

N/A
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is diagnosed with a partial thickness burn between <1% TBSA - 20% TBSA by a pediatric burn surgeon
Patient (child) is < 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months from the enrollment of the first participant or until the study number is reached
Awards & highlights

TOBI Trial Summary

This trial will compare a new smartphone app that gives burn patients and their caregivers access to expert care through text messaging, image transfer, and video-conferencing to usual face-to-face care.

Who is the study for?
This trial is for pediatric burn patients whose caregivers can communicate in English and use a smartphone with the TOBI app. The child must be under 18, have a partial thickness burn covering less than 20% of their body, and be treated within 48 hours of injury using advanced dressings.Check my eligibility
What is being tested?
The study compares traditional face-to-face burn care to telemedicine-enhanced care via the TOBI app, which allows real-time text, image sharing, and video calls between patients at home and burn experts.See study design
What are the potential side effects?
Since this trial involves standard care methods versus an application-based follow-up system rather than medication or invasive procedures, there are no direct side effects related to treatments being tested.

TOBI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a burn covering 1% to 20% of my body, diagnosed by a specialist.
Select...
My child is younger than 18 years old.
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My caregiver understands English and can communicate effectively.
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I am being treated with advanced dressings for my burn.

TOBI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months from the enrollment of the first participant or until the study number is reached
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months from the enrollment of the first participant or until the study number is reached for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants that experienced adverse events, serious adverse events, and unexpected problems
Number of participants who agree to participate in the study
Number of times problems with technology happened in the TOBI condition
+2 more
Secondary outcome measures
App metrics (TOBI condition only)
Attitudes Towards Technology and Telemedicine Questionnaire
Caregiver's perception of child's pain scores
+22 more

TOBI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TOBI armExperimental Treatment1 Intervention
A novel smartphone application for burn wound care, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging and video-conferencing. The app was designed to bring expert wound care directly to the patient's home to address barriers to healthcare, including high cost burden and time commitment (e.g., geographic limitations, transportation to burn centers, parking, lodging, meals, time away from school and work), particularly for patients/families in rural and medically underserved communities. TOBI is synced with a portal used by providers, as an adjunct to standard therapy. This burn app provides education through frequently asked questions, instructional burn dressing change videos in addition to direct communication between patient and burn expert through store-and-forward pictures and videoconferencing.
Group II: Face-to-face armActive Control1 Intervention
Standard face-to-face burn care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telemedicine enhanced burn care
2022
N/A
~70

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,196 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,677 Total Patients Enrolled

Media Library

Telemedicine Optimized Burn Intervention (Smartphone Application) Clinical Trial Eligibility Overview. Trial Name: NCT05019144 — N/A
Burns Research Study Groups: Face-to-face arm, TOBI arm
Burns Clinical Trial 2023: Telemedicine Optimized Burn Intervention Highlights & Side Effects. Trial Name: NCT05019144 — N/A
Telemedicine Optimized Burn Intervention (Smartphone Application) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05019144 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main goals of this medical experiment?

"The paramount aim of this two-year clinical research is to evaluate the percentage of participants retained in the study. Secondary objectives are assessing direct cost to patient/caregiver, gauging perception of healthcare access through Barriers to Care Questionnaire (BCQ) scores on a 0-100 scale, and monitoring PROMIS-General Self Efficacy questionnaire results for general self efficacy."

Answered by AI

Could you tell me the aggregate number of individuals involved in this clinical experiment?

"Affirmative. Records on clinicaltrials.gov verify that this research trial, which was initially listed on June 21st 2022, is presently enrolling participants. 64 subjects have to be enlisted from 1 location."

Answered by AI

Are there still vacancies available for participants in this medical trial?

"Affirmative. According to the data located on clinicaltrials.gov, this research is presently recruiting individuals and was initially posted June 21st 2022. It requires 64 patients from 1 medical centre for completion and has had its details updated as of July 7th 2022."

Answered by AI

Am I eligible to participate in this clinical trial?

"This clinical trial is recruiting 64 patients between the age of 0 and 18 who have suffered burns."

Answered by AI

Are the elderly above 85 years excluded from participating in this research?

"The study is aiming to enrol minors who are younger than 18 years old and have reached the age of 0."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Telemedicine Optimized Burn Intervention
Aaron Lesher, MD 2022. "Telemedicine Optimized Burn Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05019144.
~23 spots leftby Apr 2025
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