N/A
N=130
Telemedicine Optimized Burn Intervention
Burns · Pediatric ALL
Bottom Line
View on ClinicalTrials.gov: NCT05019144 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Number of Participants Who Agree to Participate in the Study — 66; 64 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Face-to-face burn care (Procedure); Telemedicine enhanced burn care (Procedure)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Agree to Participate in the Study |
66; 64 | — |
| PRIMARY Number of Participants Retained in the Study Over Time |
36; 42 | — |
| PRIMARY Wound Care Treatment Adherence |
76.8; 84.9 | — |
| PRIMARY Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems |
0; 0 | — |
| PRIMARY Number of Times Problems With Technology Happened in the TOBI Condition |
1 | — |
| SECONDARY Number of Days Until Wound is Healed |
11.5; 11.4 | — |
| SECONDARY Number of Unscheduled ED or Clinic Visits |
0; 2 | — |
| SECONDARY Number of Wound Complications |
0; 0 | — |
| SECONDARY Patient-reported Pain Scores |
3.1; 1.8 | — |
| SECONDARY Caregiver's Perception of Child's Pain Scores |
3.1; 1.8 | — |
| SECONDARY Attitudes Towards Technology and Telemedicine Questionnaire |
79.5; 78.0 | — |
| SECONDARY Perception of Healthcare Access |
64.5; 72.6 | — |
| SECONDARY Positive And Negative Affect Schedule (PANAS) Scores |
37; 32; 14; 13; 35; 33 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores |
47.5; 47.5; 47.5; 44.9 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores |
50.7; 47.8; 50.4; 46.8 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores |
53.5; 53.2 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores |
50.2; 50.7 | — |
| SECONDARY Peritraumatic Distress Inventory (PDI) Sores |
11.9; 13.8 | — |
| SECONDARY Perceived Stress Scale (PSS) Scores |
18.6; 19.4 | — |
| SECONDARY Posttraumatic Growth Inventory (PTGI) Scores |
54.7; 39.5 | — |
| SECONDARY Client Satisfaction Questionnaire-8 (CSQ-8) Scores |
30.8; 30.5 | — |
| SECONDARY mHealth App Usability Questionnaire (MAUQ) Scores |
6.3 | — |
| SECONDARY Total Number of Face-to-face Visits |
2.1; 1.1 | — |
| SECONDARY Total Number of TOBI Visits |
1.1 | — |
| SECONDARY Total Travel Time |
4.0; 2.3 | — |
| SECONDARY Direct Cost to Patient/Caregiver |
339.10; 258.81 | — |
| SECONDARY Time to Return to Work |
2.0; 1.3 | — |
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.
Eligibility Criteria
Inclusion criteria
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
- 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.
Exclusion Criteria
- There are no exclusion criteria. All participants who meet inclusion criteria would be eligible to participate in the study.
Data sourced from ClinicalTrials.gov (NCT05019144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.