Telemedicine Optimized Burn Intervention (TOBI)

June 23, 2025 updated by: Medical University of South Carolina

A Novel Telemedicine Optimized Burn Intervention (TOBI) for Pediatric Burn-injured Patients and Their Caregivers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 18 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

Caregiver parents and their children (patients) will be considered as participants and will be eligible for enrollment if:

  1. the patient (child) is < 18 years of age; caregiver age >18 years of age
  2. the patient is diagnosed with a partial thickness burn between <1% TBSA - 20% TBSA by a pediatric burn surgeon;
  3. the patient's burn is being treated with advanced burn dressing therapy (e.g., Silvadene™, Polysporin™, Acticoat™, Mepilex™, or Mepitel™);
  4. the patient's burn is evaluated by the MUSC burn team within 48 hours of injury;
  5. the patient's caregiver (parent or legal guardian) is able to speak, hear, and understand English, as determined during study recruitment procedures;
  6. 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;
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Face-to-face arm
Standard face-to-face burn care.
Procedure: Face-to-face burn care
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.
Experimental: TOBI arm
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Agree to Participate in the Study
Time Frame: At enrollment
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
Time Frame: From enrollment to 30 days after burn wound has healed (up to 35 days after enrollment).
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
Time Frame: Assessed weekly at clinic/telemedicine visit until burn wound was healed, up to 35 days after injury
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
Time Frame: Assessed weekly until burn wound was healed, up to 35 days
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
Time Frame: Assessed weekly until burn wound was healed, up to 35 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Attitudes Towards Technology and Telemedicine Questionnaire
Time Frame: Measured at baseline and 1-month follow-up
Looking at the change in group average scores on the Attitudes Towards Technology and Telemedicine Questionnaire (caregiver-reported) from baseline to 1 month follow-up. Scores may range between 26-130, with higher scores = more positive attitudes towards technology and telemedicine.
Measured at baseline and 1-month follow-up
Perception of Healthcare Access
Time Frame: Measured at baseline and 1-month follow-up
Looking at the change in group average scores on the Barriers to Care Questionnaire (BCQ), Pragmatics Subscale (caregiver-reported). Scores range from 0-100, with higher scores = fewer barriers and problems with access.
Measured at baseline and 1-month follow-up
Number of Days Until Wound is Healed
Time Frame: Measured during the treatment phase (2-4 weeks)
Looking at the number of days it takes for wound to heal following burn injury in both conditions
Measured during the treatment phase (2-4 weeks)
Number of Unscheduled ED or Clinic Visits
Time Frame: Measured during the treatment phase (2-4 weeks)
Looking at the number of times participants had unscheduled visits (in the ED or the clinic)
Measured during the treatment phase (2-4 weeks)
Number of Wound Complications
Time Frame: Measured during the treatment phase (2-4 weeks)
Looking at the number of wound complications (e.g., infection, conversion to deeper burn requiring surgery, conversion to deeper burn requiring a change in therapy).
Measured during the treatment phase (2-4 weeks)
Patient-reported Pain Scores
Time Frame: Measured during the treatment phase (week 1 clinic visit)
Looking at average pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most patients only attended one follow up visit but if more than one, the average score is reported below.
Measured during the treatment phase (week 1 clinic visit)
Caregiver's Perception of Child's Pain Scores
Time Frame: Measured during the treatment phase (week 1 clinic visit)
Looking at average caregiver's perception of child's pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most dyads only attended one follow up visit but if more than one, the average score is reported below.
Measured during the treatment phase (week 1 clinic visit)
Positive And Negative Affect Schedule (PANAS) Scores
Time Frame: Measured at baseline/enrollment and 1-month follow-up.
Looking at the group average scores on the PANAS questionnaire measuring positive and negative affect (caregiver-reported). The means of the positive and negative scores for PANAS are reported below along with standard deviations. The scores range between 10-50, with higher scores = higher levels of affect (both positive and negative). For positive affect, a higher score is a better outcome and for negative affect, a lower score is a better outcome. Scores are reported for baseline and 1 month after burn wound healing.
Measured at baseline/enrollment and 1-month follow-up.
Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores
Time Frame: Measured at baseline and 1-month follow-up
Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. The raw scores on the 8 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 37.1-81.1. T scores are interpreted as follows: <55 (none to slight depression), 55-59.9 (mild depression), 60-69.9 (moderate depression), >70 (severe depression). T scores and standard error are reported below.
Measured at baseline and 1-month follow-up
Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores
Time Frame: Measured at baseline and 1-month follow-up
Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The raw scores on the 7 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 36.3-82.7. T scores are interpreted as follows: <55 (none to slight anxiety), 55-59.9 (mild anxiety), 60-69.9 (moderate anxiety), >70 (severe anxiety). T scores and standard error are reported below.
Measured at baseline and 1-month follow-up
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores
Time Frame: Measured at baseline only
Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-General Self Efficacy questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 8 to 40 with higher scores indicating greater self efficacy. The raw scores on the 7 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 22.72-64.98. A T-score value of 55 indicated that the respondent has greater self-efficacy for managing emotions. Higher scores indicating more self efficacy and lower scores with less self efficacy. T scores and standard error are reported below.
Measured at baseline only
Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores
Time Frame: Measured at baseline only
Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Self-Efficacy Managing emotions questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 4-20 with higher scores indicating greater severity of anxiety. The raw scores on the 4 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 36.3-82.7. A T-score of 55 and greater indicates that the respondent has greater self efficacy and ability to manage their emotions regarding disease. A higher score than 55 indicates even more self efficacy and lower score, less. T scores and standard error are reported below.
Measured at baseline only
Peritraumatic Distress Inventory (PDI) Sores
Time Frame: Measured at baseline only
Looking at average scores on the Peritraumatic Distress Inventory (caregiver-reported). Scores range between 0-52, with higher scores = greater peritraumatic distress. An optimal cutoff score of 23 (sensitivity = 71%; specificity = 73%) is good for predicting clinically elevated PTSD 30-days post-injury.
Measured at baseline only
Perceived Stress Scale (PSS) Scores
Time Frame: Measured at 1-month follow-up only
Looking at average scores on the Perceived Stress Scale (caregiver-reported) between two conditions. Scores on the PSS can range from 0 to 40 with higher scores = higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Measured at 1-month follow-up only
Posttraumatic Growth Inventory (PTGI) Scores
Time Frame: Measured at 1-month follow-up only
Average scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth.
Measured at 1-month follow-up only
Client Satisfaction Questionnaire-8 (CSQ-8) Scores
Time Frame: Measured at 1-month follow-up only
Looking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction.
Measured at 1-month follow-up only
mHealth App Usability Questionnaire (MAUQ) Scores
Time Frame: Measured at 1-month follow-up only
Looking at average scores on the MAUQ questionnaire measuring app usability (caregiver-reported in TOBI condition only). Raw scores range between 21-147 and average scores range between 1-7, with higher overall score equivalent to higher usability of the app. The average scores and standard deviation are reported below for the TOBI group.
Measured at 1-month follow-up only
Total Number of Face-to-face Visits
Time Frame: Treatment phase (weeks 2-4)
Looking at the total number of face-to-face visits
Treatment phase (weeks 2-4)
Total Number of TOBI Visits
Time Frame: Treatment phase (weeks 2-4)
Looking at the total number of TOBI visits
Treatment phase (weeks 2-4)
Total Travel Time
Time Frame: From enrollment through treatment phase (weeks 1-4)
Looking at the total travel time in each condition as reported by the caregiver.
From enrollment through treatment phase (weeks 1-4)
Direct Cost to Patient/Caregiver
Time Frame: From enrollment through treatment phase (weeks 1-4)
Looking at the direct cost to patient/caregiver as reported by caregiver
From enrollment through treatment phase (weeks 1-4)
Time to Return to Work
Time Frame: From enrollment through the treatment phase (weeks 1-4). This included any time that the parent had was out of work because of the injury at time of occurrence or due to clinic follow up.
Looking at the average time it took patient/caregiver to return to work after burn wound injury.
From enrollment through the treatment phase (weeks 1-4). This included any time that the parent had was out of work because of the injury at time of occurrence or due to clinic follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00109037
  • K23HD098328-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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