Telemedicine Optimized Burn Intervention

NCT05019144 | Completed Results DMC

• 2 other identifiers: Pro00109037K23HD098328-01A1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Because burn patients and their caregivers often live long distances from regional burn centers, access to expert burn care is limited, resulting in a negative effect on adherence to treatment and a higher risk of wound complication. A novel smartphone application synchronized with a web portal for providers, 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, image transfer, and video-conferencing. The goal of the present study is evaluate TOBI compared to face-to-face care as usual for pediatric patients/caregivers visiting a burn center. This study will also assess the feasibility of conducting a larger-scale clinical trial in several burn centers. The app will allow the physician and patient/caregivers to make instant decisions regarding treatment, allowing for "turn on a dime" treatment decisions, rather than having the patients and families wait for scheduled clinic appointments, often hours away from home. This "on demand" medical care takes an innovative approach to increasing access to burn experts through smartphone technology and addressing adherence to prescribed treatment by increasing communication between provider and patients.

Conditions

Burns; Pediatric ALL

Keywords

Pediatrics; Telemedicine; Mobile health; Burns

Outcome Measures

Primary Outcomes (5)

• Number of Participants Who Agree to Participate in the Study

  Looking at the number of participants (parents and children) who agree to enroll in the study at the time of burn injury versus the total number of participants who were approached to participate in the study.

  At enrollment

• Number of Participants Retained in the Study Over Time

  Looking at the number of participants retained in the study versus those lost to attrition

  From enrollment to 30 days after burn wound has healed (up to 35 days after enrollment).

• Wound Care Treatment Adherence

  Looking at the percentage of patient/caregiver dyads who adhered to prescribed burn wound care treatment protocol. A wound care fidelity checklist was used at each visit to determine the percentage of wound care adherence per visit. These percentages were then averaged for each weekly visit to give the value below.

  Assessed weekly at clinic/telemedicine visit until burn wound was healed, up to 35 days after injury

• Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems

  Looking at the number of child participants in each condition that experienced adverse events, serious adverse events, and unexpected problems. Adverse events in this study included infection, delay in wound care or non-healing wound. Adult caregivers are not included in this as they did not have burn wounds that were assesssed.

  Assessed weekly until burn wound was healed, up to 35 days

• Number of Times Problems With Technology Happened in the TOBI Condition

  Looking at the number of times providers or participants experienced and reported technological problems with TOBI

  Assessed weekly until burn wound was healed, up to 35 days

Secondary Outcomes (22)

• Number of Days Until Wound is Healed

  Measured during the treatment phase (2-4 weeks)

• Number of Unscheduled ED or Clinic Visits

  Measured during the treatment phase (2-4 weeks)

• Number of Wound Complications

  Measured during the treatment phase (2-4 weeks)

• Patient-reported Pain Scores

  Measured during the treatment phase (week 1 clinic visit)

• Caregiver's Perception of Child's Pain Scores

  Measured during the treatment phase (week 1 clinic visit)

Study Arms (2)

Face-to-face arm

ACTIVE COMPARATOR

Standard face-to-face burn care.

Procedure: Face-to-face burn care

TOBI arm

EXPERIMENTAL

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.

Procedure: Telemedicine enhanced burn care

Interventions

Face-to-face burn care PROCEDURE

If the participants are assigned to FTF care, they will receive standard burn care including a return follow-up in the burn clinic on a routine basis as prescribed by the clinical burn team (at least once per week) until the burn has healed.

Face-to-face arm

Telemedicine enhanced burn care PROCEDURE

Participants assigned to TOBI will be given instructions how to download and use TOBI on a smartphone, including how to interface with burn clinicians using text-messaging, videoconferencing, and sending photos of the child's burn(s). The participants will have scheduled video visits with the care provider at least weekly until the burn has healed. The participants will be able to use other features of the app, such as text-messaging and sending photos of the burn(s), as needed. The participants will be able to use standard FTF burn care as well. They will be given instructions how to contact the burn team through the hospital paging operator if TOBI is unavailable or there is an emergency.

TOBI arm

Eligibility Criteria

• Age: 0 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver parents and their children (patients) will be considered as participants and will be eligible for enrollment if:
• the patient (child) is \< 18 years of age; caregiver age \>18 years of age
• the patient is diagnosed with a partial thickness burn between \<1% TBSA - 20% TBSA by a pediatric burn surgeon;
• the patient's burn is being treated with advanced burn dressing therapy (e.g., Silvadene™, Polysporin™, Acticoat™, Mepilex™, or Mepitel™);
• the patient's burn is evaluated by the MUSC burn team within 48 hours of injury;
• the patient's caregiver (parent or legal guardian) is able to speak, hear, and understand English, as determined during study recruitment procedures;
• the caregiver owns and is capable of using a smart device (an Android or iOS smartphone) with permission to download TOBI app from the Google Store or AppStore;
• able to comply with outpatient clinic visits.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Burns; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Aaron P. Lesher
• Organization: Medical University of South Carolina

leshera@musc.edu

843-408-6782

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: June 1, 2022
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)