Telemedicine enhanced burn care for Burns

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medical University of South Carolina, Charleston, SC
Burns+1 More
Telemedicine enhanced burn care - Procedure
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a smartphone app can improve burn care for patients and their caregivers.

See full description

Eligible Conditions

  • Burns
  • ALL, Pediatric

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Telemedicine enhanced burn care will improve 5 primary outcomes and 36 secondary outcomes in patients with Burns. Measurement will happen over the course of Measured at baseline only.

Month 24
App metrics (TOBI condition only)
Direct cost to patient/caregiver
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
Percentage of participants retained in the study over time
TOBI treatment fidelity
Time to return to work/school
Total number of TOBI visits
Total number of face-to-face visits
Total travel time
Measured at 1-month follow-up only
Client Satisfaction Questionnaire-8 (CSQ-8) scores
Client Satisfaction Questionnaire-8 scores
MAUQ Scores
Perceived Stress Scale (PSS) scores
Perceived Stress Scale scores
Posttraumatic Growth Inventory (PTGI) scores
Posttraumatic Growth Inventory scores
mHealth App Usability Questionnaire (MAUQ) Scores
Measured at baseline and 1-month follow-up
Attitudes Towards Technology and Telemedicine Questionnaire
PANAS scores
PROMIS-Anxiety (4-item form) scores
PROMIS-Depression (4-item form) scores
Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) (4-item form) scores
Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) (4-item form) scores
Perception of Healthcare Access
Positive And Negative Affect Schedule (PANAS) scores
Measured at baseline only
PROMIS-General-Self-Efficacy (4-item form) scores
PROMIS-Self-Efficacy-Manage-Emotions (4-item form) scores
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) (4-item form) scores
Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) (4-item form) scores
Peritraumatic Distress Inventory (PDI) sores
Peritraumatic Distress Inventory sores
Week 4
Caregiver's perception of child's pain scores
Number of days until wound is healed
Number of unscheduled ED/clinic and video visits
PROMIS-Sleep (4-item form) scores
Patient-Reported Outcomes Measurement Information System - Sleep (PROMIS-Sleep) (4-item form) scores
Patient-reported pain scores
Time to treatment of wound complication
Treatment adherence

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Face-to-face arm
1 of 2
TOBI arm
1 of 2
Active Control
Experimental Treatment

This trial requires 64 total participants across 2 different treatment groups

This trial involves 2 different treatments. Telemedicine Enhanced Burn Care is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

TOBI arm
Procedure
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.
Face-to-face arm
Procedure
Standard face-to-face burn care.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months from the enrollment of the first participant or until the study number is reached
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months from the enrollment of the first participant or until the study number is reached for reporting.

Who is running the study

Principal Investigator
A. L.
Prof. Aaron Lesher, MD
Medical University of South Carolina

Closest Location

Medical University of South Carolina - Charleston, SC

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
able to comply with outpatient clinic visits.
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 burn is being treated with advanced burn dressing therapy (e.g., Silvadene™, Polysporin™, Acticoat™, Mepilex™, or Mepitel™);
the 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 patient/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;

Patient Q&A Section

What are common treatments for burns?

"Common burn treatments include topical dressings and skin grafts, antibiotics (aminoglycosides and penicillins), analgesics (opiates), antihepatitis C virus, and corticosteroids. There is no cure for burns, so treatment is focused on symptoms and wound infection control, and is dependent on the specific patient." - Anonymous Online Contributor

Unverified Answer

How many people get burns a year in the United States?

"This model predicts that as many as 1.36 million people in the USA may get serious burns each year, particularly the elderly, those with diabetes, and women. This is especially significant as [even relatively minor burns are associated with significant complication rates, mortality and increased hospital length of stay].." - Anonymous Online Contributor

Unverified Answer

Can burns be cured?

"We can say that there is a significant correlation between burn extent and duration of patient survival. There is a need for further study, focusing on prevention measures by encouraging public education and implementing stricter burns burn laws in order to decrease the morbidity." - Anonymous Online Contributor

Unverified Answer

What are the signs of burns?

"This paper explains the common causes of burns. In some cases, burns may resemble the signs of other diseases such as the symptoms of pneumonia. Many of the symptoms described in this paper can be part of the initial response to any type of injury. In burned patients, the most common symptoms, such as pain, itching, bleeding and heat sensation may be similar to patients with arthritis or asthma. In extreme cases, burns may simulate symptoms of burns that can even be fatal. However, in most cases, burns can be easily avoided." - Anonymous Online Contributor

Unverified Answer

What is burns?

"Burns have become a global public health crisis that are a cause of significant mortality and physical, mental and social harm in people, the environment and society. The risk of dying as a result of injuries to the skin or subcutaneous tissue is approximately three times higher than the general population. Patients and carers need to receive an accurate, complete and comprehensive history of any recent recent injury, as well as current burns and any burns in the past. They should be offered prompt and appropriate wound care at the first stage of admission, to prevent the development of further complications." - Anonymous Online Contributor

Unverified Answer

What causes burns?

"These burn causes are a result of a number of contributing factors including heating, radiant heat (heat from the direct contact of hot objects), ultraviolet light, and physical injury. There is a need for improved fire prevention campaigns within the workplace, with stricter legislation limiting the use of flammable substances (see 'Health effects'). The major source of burns is within the home. To prevent burns in childhood, it is best to use a safer household cooking method as well as limit the use of hot cooking appliances." - Anonymous Online Contributor

Unverified Answer

Does burns run in families?

"There is no evidence from this large cohort study that family history of burn has a strong influence on the occurrence of new burn incidence. Recent findings of this prospective study do not support the hypothesis that burn is a complex polygenic disorder, and a clear environmental component is also missing within a large number of families with a considerable genetic contribution." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving telemedicine enhanced burn care?

"A review of the literature revealed few studies for or against telemedicine. These studies are currently being performed cautiously, yet with an obvious need for greater clinical trials. There are many barriers to this technology to embrace, but with a little more study, there is a chance of improving future burn treatment." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for burns?

"The authors conclude that the likelihood of favorable therapeutic benefit of a given clinical trial is a dynamic response and unlikely to be static. Clinical trials are not perfect, but may be an imperfect surrogate for patients' preferences. The authors propose a clinical trials participation strategy to help patients' decide what treatments they want to try." - Anonymous Online Contributor

Unverified Answer

Is telemedicine enhanced burn care typically used in combination with any other treatments?

"Telemedicine may be particularly useful in the acute phase of burn management. Tele-monitoring of patients with suspected escharotomy site healing, the follow-up of patients with prolonged hyperbaric oxygen therapy, and monitoring of airway or wound infections may be helpful." - Anonymous Online Contributor

Unverified Answer

How does telemedicine enhanced burn care work?

"A remote specialist evaluation and treatment of burn injuries can provide rapid, accurate and effective management of patients with burns. These preliminary data suggest a high level of patient satisfaction with the service provided." - Anonymous Online Contributor

Unverified Answer

Is telemedicine enhanced burn care safe for people?

"Implementation of this form of telemedicine was reported to be well accepted by the patient and nurses involved in its administration and it led to more effective care. The use of telemedicine at the scene is safe for both people and has several benefits." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Burns by sharing your contact details with the study coordinator.