BurnsTOBINCT05019144
Telemedicine Optimized Burn Intervention
A study testing Face-to-face burn care and Telemedicine enhanced burn care in people with Burns and Pediatric ALL, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 80 years
- Conditions the study is for
- Burns, Pediatric ALL
- What is being tested?
- Face-to-face burn care and Telemedicine enhanced burn care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 8 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria. All participants who meet inclusion criteria would be eligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
- Conditions
- Burns, Pediatric ALL
- Being tested
- Face-to-face burn care, Telemedicine enhanced burn care
- Keywords
- Pediatrics, Telemedicine, Mobile health, Burns
- Medical subject headings
- Burns, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face burn careProcedure or surgery
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.
Telemedicine enhanced burn careProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face arm | Active comparator | Standard face-to-face burn care. Receives: 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. Receives: Procedure: Telemedicine enhanced burn care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Assessed weekly until burn wound was healed, up to 35 days
Secondary outcomes (22)
Number of Days Until Wound is Healed
Looking at the number of days it takes for wound to heal following burn injury in both conditions
Measured: Measured during the treatment phase (2-4 weeks)
Number of Unscheduled ED or Clinic Visits
Looking at the number of times participants had unscheduled visits (in the ED or the clinic)
Measured: Measured during the treatment phase (2-4 weeks)
Number of Wound Complications
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: Measured during the treatment phase (2-4 weeks)
Patient-reported Pain Scores
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: Measured during the treatment phase (week 1 clinic visit)
Caregiver's Perception of Child's Pain Scores
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: Measured during the treatment phase (week 1 clinic visit)
Attitudes Towards Technology and Telemedicine Questionnaire
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: Measured at baseline and 1-month follow-up
Perception of Healthcare Access
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: Measured at baseline and 1-month follow-up
Positive And Negative Affect Schedule (PANAS) Scores
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: Measured at baseline/enrollment and 1-month follow-up.
Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores
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: Measured at baseline and 1-month follow-up
Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores
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: Measured at baseline and 1-month follow-up
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores
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: Measured at baseline only
Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores
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: Measured at baseline only
Peritraumatic Distress Inventory (PDI) Sores
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: Measured at baseline only
Perceived Stress Scale (PSS) Scores
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: Measured at 1-month follow-up only
Posttraumatic Growth Inventory (PTGI) Scores
Average scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth.
Measured: Measured at 1-month follow-up only
Client Satisfaction Questionnaire-8 (CSQ-8) Scores
Looking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction.
Measured: Measured at 1-month follow-up only
mHealth App Usability Questionnaire (MAUQ) Scores
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: Measured at 1-month follow-up only
Total Number of Face-to-face Visits
Looking at the total number of face-to-face visits
Measured: Treatment phase (weeks 2-4)
Total Number of TOBI Visits
Looking at the total number of TOBI visits
Measured: Treatment phase (weeks 2-4)
Total Travel Time
Looking at the total travel time in each condition as reported by the caregiver.
Measured: From enrollment through treatment phase (weeks 1-4)
Direct Cost to Patient/Caregiver
Looking at the direct cost to patient/caregiver as reported by caregiver
Measured: From enrollment through treatment phase (weeks 1-4)
Time to Return to Work
Looking at the average time it took patient/caregiver to return to work after burn wound injury.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Jun 2022
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019144
- Sponsor's protocol ID
- Pro00109037
- Other IDs
- K23HD098328-01A1
- Acronym
- TOBI
- Status last verified
- Jun 2025
- First submitted
- 18 Aug 2021
- Last updated
- 11 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Telemedicine Optimized Burn Intervention (TOBI) for Pediatric Burn-injured Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT05019144
- Acronym / sponsor ID
- TOBI / Pro00109037
- Conditions
- Burns, Pediatric ALL
- Keywords
- Pediatrics, Telemedicine, Mobile health, Burns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Posted 11 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-face arm | Active comparator | Procedure: Face-to-face burn careStandard face-to-face burn care. |
| TOBI arm | Experimental | Procedure: Telemedicine enhanced burn careA 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. |
Who may qualify
- Ages
- 0 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (1 listed)
- There are no exclusion criteria. All participants who meet inclusion criteria would be eligible to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-face burn careIf 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. | Procedure or surgery | Face-to-face arm |
| Telemedicine enhanced burn careParticipants 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. | Procedure or surgery | TOBI arm |
Primary outcome
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.
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
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.
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.
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
22 secondary outcomes
Number of Days Until Wound is Healed
Time frame: 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)
Number of Wound Complications
Time frame: Measured during the treatment phase (2-4 weeks)
Patient-reported Pain Scores
Time frame: 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)
Attitudes Towards Technology and Telemedicine Questionnaire
Time frame: Measured at baseline and 1-month follow-up
Perception of Healthcare Access
Time frame: Measured at baseline and 1-month follow-up
Positive And Negative Affect Schedule (PANAS) Scores
Time frame: 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
Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores
Time frame: 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
Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores
Time frame: Measured at baseline only
Peritraumatic Distress Inventory (PDI) Sores
Time frame: Measured at baseline only
Perceived Stress Scale (PSS) Scores
Time frame: Measured at 1-month follow-up only
Posttraumatic Growth Inventory (PTGI) Scores
Time frame: Measured at 1-month follow-up only
Client Satisfaction Questionnaire-8 (CSQ-8) Scores
Time frame: Measured at 1-month follow-up only
mHealth App Usability Questionnaire (MAUQ) Scores
Time frame: Measured at 1-month follow-up only
Total Number of Face-to-face Visits
Time frame: Treatment phase (weeks 2-4)
Total Number of TOBI Visits
Time frame: Treatment phase (weeks 2-4)
Total Travel Time
Time frame: From enrollment through treatment phase (weeks 1-4)
Direct Cost to Patient/Caregiver
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Burns
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
Not yet recruiting
Impact of Range of Motion Exercises on Pain and Functional Ability
Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face burn care and Telemedicine enhanced burn care in people with Burns and Pediatric ALL, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Agree to Participate in the Study (time frame: At enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.