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Telemedicine Optimized Burn Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05019144
Acronym
TOBI
Enrollment
130
Registered
2021-08-24
Start date
2022-06-01
Completion date
2024-03-08
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Pediatric ALL

Keywords

Pediatrics, Telemedicine, Mobile health, Burns

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.

Interventions

PROCEDUREFace-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.

PROCEDURETelemedicine 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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
0 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Agree to Participate in the StudyAt enrollmentLooking 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 TimeFrom 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 AdherenceAssessed weekly at clinic/telemedicine visit until burn wound was healed, up to 35 days after injuryLooking 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 ProblemsAssessed weekly until burn wound was healed, up to 35 daysLooking 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 ConditionAssessed weekly until burn wound was healed, up to 35 daysLooking at the number of times providers or participants experienced and reported technological problems with TOBI

Secondary

MeasureTime frameDescription
Attitudes Towards Technology and Telemedicine QuestionnaireMeasured at baseline and 1-month follow-upLooking 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.
Perception of Healthcare AccessMeasured at baseline and 1-month follow-upLooking 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.
Positive And Negative Affect Schedule (PANAS) ScoresMeasured 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.
Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) ScoresMeasured at baseline and 1-month follow-upLooking 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.
Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) ScoresMeasured at baseline and 1-month follow-upLooking 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.
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) ScoresMeasured at baseline onlyLooking 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.
Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) ScoresMeasured at baseline onlyLooking 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.
Peritraumatic Distress Inventory (PDI) SoresMeasured at baseline onlyLooking 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.
Number of Days Until Wound is HealedMeasured 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
Posttraumatic Growth Inventory (PTGI) ScoresMeasured at 1-month follow-up onlyAverage scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth.
Client Satisfaction Questionnaire-8 (CSQ-8) ScoresMeasured at 1-month follow-up onlyLooking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction.
mHealth App Usability Questionnaire (MAUQ) ScoresMeasured at 1-month follow-up onlyLooking 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.
Total Number of Face-to-face VisitsTreatment phase (weeks 2-4)Looking at the total number of face-to-face visits
Total Number of TOBI VisitsTreatment phase (weeks 2-4)Looking at the total number of TOBI visits
Total Travel TimeFrom enrollment through treatment phase (weeks 1-4)Looking at the total travel time in each condition as reported by the caregiver.
Direct Cost to Patient/CaregiverFrom enrollment through treatment phase (weeks 1-4)Looking at the direct cost to patient/caregiver as reported by caregiver
Time to Return to WorkFrom 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.
Perceived Stress Scale (PSS) ScoresMeasured at 1-month follow-up onlyLooking 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.
Number of Unscheduled ED or Clinic VisitsMeasured during the treatment phase (2-4 weeks)Looking at the number of times participants had unscheduled visits (in the ED or the clinic)
Number of Wound ComplicationsMeasured 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).
Patient-reported Pain ScoresMeasured 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.
Caregiver's Perception of Child's Pain ScoresMeasured 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.

Countries

United States

Participant flow

Recruitment details

Burn patients were recruited from burn clinic and the inpatient hospital setting to participate a study comparing face to face outpatient wound care to virtual wound care.

Pre-assignment details

Parents/caregivers \*and\* children were considered enrolled in the study as a dyad, although most of the outcomes were reported by the parent instead of the child. Since demographic data was collected on both the caregiver and the child, the Total Started number is 130 (65 caregivers AND 65 children) as there were 65 dyads enrolled.

Participants by arm

ArmCount
Face-to-face Arm
Standard face-to-face burn care. 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.
66
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. 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. 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.
64
Total130

Baseline characteristics

CharacteristicTOBI ArmFace-to-face ArmTotal
Age, Categorical
Parents/Caregivers
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Parents/Caregivers
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Parents/Caregivers
Between 18 and 65 years
32 Participants33 Participants65 Participants
Age, Categorical
Patients
<=18 years
32 Participants33 Participants65 Participants
Age, Categorical
Patients
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Patients
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous
Parents/Caregivers
35 years34 years34 years
Age, Continuous
Patients
8 years5 years6 years
Race (NIH/OMB)
Parents/Caregivers
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parents/Caregivers
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parents/Caregivers
Black or African American
13 Participants13 Participants26 Participants
Race (NIH/OMB)
Parents/Caregivers
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parents/Caregivers
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parents/Caregivers
Unknown or Not Reported
1 Participants5 Participants6 Participants
Race (NIH/OMB)
Parents/Caregivers
White
18 Participants15 Participants33 Participants
Race (NIH/OMB)
Patients
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Patients
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Patients
Black or African American
13 Participants13 Participants26 Participants
Race (NIH/OMB)
Patients
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Patients
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Patients
Unknown or Not Reported
1 Participants5 Participants6 Participants
Race (NIH/OMB)
Patients
White
18 Participants15 Participants33 Participants
Region of Enrollment
United States
64 participants66 participants130 participants
Sex: Female, Male
Parents/Caregivers
Female
32 Participants28 Participants60 Participants
Sex: Female, Male
Parents/Caregivers
Male
0 Participants5 Participants5 Participants
Sex: Female, Male
Patients
Female
16 Participants15 Participants31 Participants
Sex: Female, Male
Patients
Male
16 Participants18 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 32
other
Total, other adverse events
0 / 332 / 32
serious
Total, serious adverse events
0 / 330 / 32

Outcome results

Primary

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.

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Face-to-face ArmNumber of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems0 Participants
TOBI ArmNumber of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems0 Participants
Primary

Number of Participants Retained in the Study Over Time

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

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

Population: Parents/caregivers and patients were considered to be enrolled together as a dyad, but are reported here as caregiver and patient.

ArmMeasureValue (NUMBER)
Face-to-face ArmNumber of Participants Retained in the Study Over Time36 participants
TOBI ArmNumber of Participants Retained in the Study Over Time42 participants
Primary

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.

Time frame: At enrollment

Population: This includes caregivers and their children.

ArmMeasureValue (NUMBER)
Face-to-face ArmNumber of Participants Who Agree to Participate in the Study66 participants
TOBI ArmNumber of Participants Who Agree to Participate in the Study64 participants
Primary

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

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

Population: Only participants in the TOBI arm were evaluated for issues with technology as the face to face group did not interact with technology.

ArmMeasureValue (NUMBER)
TOBI ArmNumber of Times Problems With Technology Happened in the TOBI Condition1 number of technological problems
Primary

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.

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

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmWound Care Treatment Adherence76.8 percentage of wound care adherenceStandard Deviation 40.1
TOBI ArmWound Care Treatment Adherence84.9 percentage of wound care adherenceStandard Deviation 29.1
Secondary

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.

Time frame: Measured at baseline and 1-month follow-up

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmAttitudes Towards Technology and Telemedicine Questionnaire79.5 units on a scaleStandard Deviation 6.3
TOBI ArmAttitudes Towards Technology and Telemedicine Questionnaire78.0 units on a scaleStandard Deviation 8.4
Secondary

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.

Time frame: Measured during the treatment phase (week 1 clinic visit)

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmCaregiver's Perception of Child's Pain Scores3.1 score on a scaleStandard Deviation 3
TOBI ArmCaregiver's Perception of Child's Pain Scores1.8 score on a scaleStandard Deviation 1.7
Secondary

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.

Time frame: Measured at 1-month follow-up only

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmClient Satisfaction Questionnaire-8 (CSQ-8) Scores30.8 units on a scaleStandard Deviation 3
TOBI ArmClient Satisfaction Questionnaire-8 (CSQ-8) Scores30.5 units on a scaleStandard Deviation 3
Secondary

Direct Cost to Patient/Caregiver

Looking at the direct cost to patient/caregiver as reported by caregiver

Time frame: From enrollment through treatment phase (weeks 1-4)

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmDirect Cost to Patient/Caregiver339.10 dollarsStandard Deviation 568.14
TOBI ArmDirect Cost to Patient/Caregiver258.81 dollarsStandard Deviation 390.38
Secondary

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.

Time frame: Measured at 1-month follow-up only

Population: The face-to-face arm did not use the TOBI app at all, therefore they did not take the MAUQ to rate the app.

ArmMeasureValue (MEAN)Dispersion
TOBI ArmmHealth App Usability Questionnaire (MAUQ) Scores6.3 units on a scaleStandard Deviation 0.8
Secondary

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

Time frame: Measured during the treatment phase (2-4 weeks)

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmNumber of Days Until Wound is Healed11.5 days to wound healedStandard Deviation 4.3
TOBI ArmNumber of Days Until Wound is Healed11.4 days to wound healedStandard Deviation 3.9
Secondary

Number of Unscheduled ED or Clinic Visits

Looking at the number of times participants had unscheduled visits (in the ED or the clinic)

Time frame: Measured during the treatment phase (2-4 weeks)

ArmMeasureValue (NUMBER)
Face-to-face ArmNumber of Unscheduled ED or Clinic Visits0 number of unscheduled ED/clinic visits
TOBI ArmNumber of Unscheduled ED or Clinic Visits2 number of unscheduled ED/clinic visits
Secondary

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).

Time frame: Measured during the treatment phase (2-4 weeks)

ArmMeasureValue (NUMBER)
Face-to-face ArmNumber of Wound Complications0 number of wound complications
TOBI ArmNumber of Wound Complications0 number of wound complications
Secondary

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.

Time frame: Measured at baseline and 1-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Face-to-face ArmPatient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) ScoresBaseline50.7 T-scoreStandard Error 9.1
Face-to-face ArmPatient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores1 month follow up50.4 T-scoreStandard Error 6.8
TOBI ArmPatient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) ScoresBaseline47.8 T-scoreStandard Error 7.8
TOBI ArmPatient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores1 month follow up46.8 T-scoreStandard Error 7.6
Secondary

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.

Time frame: Measured at baseline and 1-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Face-to-face ArmPatient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) ScoresBaseline47.5 T-scoreStandard Error 7.6
Face-to-face ArmPatient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores1 month follow up47.5 T-scoreStandard Error 8
TOBI ArmPatient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) ScoresBaseline47.5 T-scoreStandard Error 6.2
TOBI ArmPatient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores1 month follow up44.9 T-scoreStandard Error 6.1
Secondary

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.

Time frame: Measured at baseline only

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmPatient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores53.5 T-scoreStandard Error 10.1
TOBI ArmPatient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores53.2 T-scoreStandard Error 8.8
Secondary

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.

Time frame: Measured at baseline only

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmPatient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores50.2 T-scoreStandard Error 9.1
TOBI ArmPatient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores50.7 T-scoreStandard Error 6.6
Secondary

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.

Time frame: Measured during the treatment phase (week 1 clinic visit)

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmPatient-reported Pain Scores3.1 units on a scaleStandard Deviation 3
TOBI ArmPatient-reported Pain Scores1.8 units on a scaleStandard Deviation 1.7
Secondary

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.

Time frame: Measured at 1-month follow-up only

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmPerceived Stress Scale (PSS) Scores18.6 units on a scaleStandard Deviation 2.7
TOBI ArmPerceived Stress Scale (PSS) Scores19.4 units on a scaleStandard Deviation 3
Secondary

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.

Time frame: Measured at baseline and 1-month follow-up

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmPerception of Healthcare Access64.5 units on a scaleStandard Deviation 25.5
TOBI ArmPerception of Healthcare Access72.6 units on a scaleStandard Deviation 20.3
Secondary

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.

Time frame: Measured at baseline only

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmPeritraumatic Distress Inventory (PDI) Sores11.9 units on a scaleStandard Deviation 8.1
TOBI ArmPeritraumatic Distress Inventory (PDI) Sores13.8 units on a scaleStandard Deviation 8.3
Secondary

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.

Time frame: Measured at baseline/enrollment and 1-month follow-up.

ArmMeasureGroupValue (MEAN)Dispersion
Face-to-face ArmPositive And Negative Affect Schedule (PANAS) ScoresBaseline Positive Affect37 units on a scaleStandard Deviation 7
Face-to-face ArmPositive And Negative Affect Schedule (PANAS) ScoresBaseline Negative Affect14 units on a scaleStandard Deviation 4
Face-to-face ArmPositive And Negative Affect Schedule (PANAS) Scores1 month follow up Positive Affect35 units on a scaleStandard Deviation 8
Face-to-face ArmPositive And Negative Affect Schedule (PANAS) Scores1 month follow up Negative Affect13 units on a scaleStandard Deviation 4
TOBI ArmPositive And Negative Affect Schedule (PANAS) Scores1 month follow up Negative Affect11 units on a scaleStandard Deviation 5
TOBI ArmPositive And Negative Affect Schedule (PANAS) ScoresBaseline Positive Affect32 units on a scaleStandard Deviation 8
TOBI ArmPositive And Negative Affect Schedule (PANAS) Scores1 month follow up Positive Affect33 units on a scaleStandard Deviation 7
TOBI ArmPositive And Negative Affect Schedule (PANAS) ScoresBaseline Negative Affect13 units on a scaleStandard Deviation 5
Secondary

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.

Time frame: Measured at 1-month follow-up only

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmPosttraumatic Growth Inventory (PTGI) Scores54.7 units on a scaleStandard Deviation 31.9
TOBI ArmPosttraumatic Growth Inventory (PTGI) Scores39.5 units on a scaleStandard Deviation 35.6
Secondary

Time to Return to Work

Looking at the average time it took patient/caregiver to return to work after burn wound injury.

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.

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmTime to Return to Work2.0 daysStandard Deviation 2.2
TOBI ArmTime to Return to Work1.3 daysStandard Deviation 1.5
Secondary

Total Number of Face-to-face Visits

Looking at the total number of face-to-face visits

Time frame: Treatment phase (weeks 2-4)

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmTotal Number of Face-to-face Visits2.1 number of visitsStandard Deviation 0.8
TOBI ArmTotal Number of Face-to-face Visits1.1 number of visitsStandard Deviation 0.3
Secondary

Total Number of TOBI Visits

Looking at the total number of TOBI visits

Time frame: Treatment phase (weeks 2-4)

Population: This outcome only pertains to the TOBI arm as the face-to-face arm did not have any TOBI visits.

ArmMeasureValue (MEAN)Dispersion
TOBI ArmTotal Number of TOBI Visits1.1 number of visitsStandard Deviation 0.6
Secondary

Total Travel Time

Looking at the total travel time in each condition as reported by the caregiver.

Time frame: From enrollment through treatment phase (weeks 1-4)

ArmMeasureValue (MEAN)Dispersion
Face-to-face ArmTotal Travel Time4.0 hoursStandard Deviation 3.1
TOBI ArmTotal Travel Time2.3 hoursStandard Deviation 2.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026