An interventional study of Face-to-face burn care and Telemedicine enhanced burn care in Burns and Pediatric ALL, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 0 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Diagnostic
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 130 is above the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Caregiver parents and their children (patients) will be considered as participants and will be eligible for enrollment if:
Exclusion Criteria:
Standard face-to-face burn care.
Procedure: Face-to-face burn care
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
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.
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.
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
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).
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
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
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
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)
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)
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)
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)
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)
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
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
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.
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
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
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
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
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
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
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
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
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
Total Number of Face-to-face Visits
Looking at the total number of face-to-face visits
Time frame: Treatment phase (weeks 2-4)
Total Number of TOBI Visits
Looking at the total number of TOBI visits
Time frame: Treatment phase (weeks 2-4)
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)
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)
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.
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.
| Milestone | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Started | 66 | 64 |
| Caregivers | 33 | 32 |
| Children | 33 | 32 |
| Completed | 36 | 42 |
| Not completed | 30 | 22 |
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.
| participants | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Number of Participants Who Agree to Participate in the Study | 66 | 64 |
Looking at the number of participants retained in the study versus those lost to attrition
| participants | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Number of Participants Retained in the Study Over Time | 36 | 42 |
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.
| percentage of wound care adherence | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Wound Care Treatment Adherence | 76.8 ± 40.1 | 84.9 ± 29.1 |
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.
| Participants | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems | 0 | 0 |
Looking at the number of times providers or participants experienced and reported technological problems with TOBI
| number of technological problems | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Number of Times Problems With Technology Happened in the TOBI Condition | — | 1 |
Looking at the number of days it takes for wound to heal following burn injury in both conditions
| days to wound healed | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Number of Days Until Wound is Healed | 11.5 ± 4.3 | 11.4 ± 3.9 |
Looking at the number of times participants had unscheduled visits (in the ED or the clinic)
| number of unscheduled ED/clinic visits | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Number of Unscheduled ED or Clinic Visits | 0 | 2 |
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).
| number of wound complications | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Number of Wound Complications | 0 | 0 |
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.
| units on a scale | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Patient-reported Pain Scores | 3.1 ± 3 | 1.8 ± 1.7 |
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.
| score on a scale | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Caregiver's Perception of Child's Pain Scores | 3.1 ± 3.0 | 1.8 ± 1.7 |
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.
| units on a scale | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Attitudes Towards Technology and Telemedicine Questionnaire | 79.5 ± 6.3 | 78.0 ± 8.4 |
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.
| units on a scale | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Perception of Healthcare Access | 64.5 ± 25.5 | 72.6 ± 20.3 |
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.
| units on a scale | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Baseline Positive Affect | 37 ± 7 | 32 ± 8 |
| Baseline Negative Affect | 14 ± 4 | 13 ± 5 |
| 1 month follow up Positive Affect | 35 ± 8 | 33 ± 7 |
| 1 month follow up Negative Affect | 13 ± 4 | 11 ± 5 |
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.
| T-score | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Baseline | 47.5 ± 7.6 | 47.5 ± 6.2 |
| 1 month follow up | 47.5 ± 8.0 | 44.9 ± 6.1 |
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.
| T-score | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Baseline | 50.7 ± 9.1 | 47.8 ± 7.8 |
| 1 month follow up | 50.4 ± 6.8 | 46.8 ± 7.6 |
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.
| T-score | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores | 53.5 ± 10.1 | 53.2 ± 8.8 |
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.
| T-score | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores | 50.2 ± 9.1 | 50.7 ± 6.6 |
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.
| units on a scale | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Peritraumatic Distress Inventory (PDI) Sores | 11.9 ± 8.1 | 13.8 ± 8.3 |
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.
| units on a scale | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Perceived Stress Scale (PSS) Scores | 18.6 ± 2.7 | 19.4 ± 3.0 |
Average scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth.
| units on a scale | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Posttraumatic Growth Inventory (PTGI) Scores | 54.7 ± 31.9 | 39.5 ± 35.6 |
Looking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction.
| units on a scale | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Client Satisfaction Questionnaire-8 (CSQ-8) Scores | 30.8 ± 3 | 30.5 ± 3 |
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.
| units on a scale | Face-to-face Arm | TOBI Arm |
|---|---|---|
| mHealth App Usability Questionnaire (MAUQ) Scores | — | 6.3 ± 0.8 |
Looking at the total number of face-to-face visits
| number of visits | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Total Number of Face-to-face Visits | 2.1 ± 0.8 | 1.1 ± 0.3 |
Looking at the total number of TOBI visits
| number of visits | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Total Number of TOBI Visits | — | 1.1 ± 0.6 |
Looking at the total travel time in each condition as reported by the caregiver.
| hours | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Total Travel Time | 4.0 ± 3.1 | 2.3 ± 2.5 |
Looking at the direct cost to patient/caregiver as reported by caregiver
| dollars | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Direct Cost to Patient/Caregiver | 339.10 ± 568.14 | 258.81 ± 390.38 |
Looking at the average time it took patient/caregiver to return to work after burn wound injury.
| days | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Time to Return to Work | 2.0 ± 2.2 | 1.3 ± 1.5 |
Collected over For each child participant dyad, adverse event data was only collected on the child participant up to 46 days after burn wound injury.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Face-to-face Arm | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| TOBI Arm | 0/32 (0%) | 0/32 (0%) | 2/32 (6.3%) |
| Event | Face-to-face Arm | TOBI Arm |
|---|---|---|
| Unscheduled visit to the ED or ClinicSkin and subcutaneous tissue disorders | 0/33 | 2/32 |
Parents/caregivers and patients were considered to be enrolled so baseline characteristics will be listed for both patients and their caregivers.
| Age, Categorical(Participants) | Face-to-face Arm | TOBI Arm | Total |
|---|---|---|---|
| Parents/Caregivers — <=18 years | 0 | 0 | 0 |
| Parents/Caregivers — Between 18 and 65 years | 33 | 32 | 65 |
| Parents/Caregivers — >=65 years | 0 | 0 | 0 |
| Patients — <=18 years | 33 | 32 | 65 |
| Patients — Between 18 and 65 years | 0 | 0 | 0 |
| Patients — >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Face-to-face Arm | TOBI Arm | Total |
|---|---|---|---|
| Parents/Caregivers | 34 (23.2 to 44.8) | 35 (25.2 to 44.8) | 34 (23 to 45) |
| Patients | 5 (1 to 8) | 8 (2.25 to 15) | 6 (1 to 10) |
| Sex: Female, Male(Participants) | Face-to-face Arm | TOBI Arm | Total |
|---|---|---|---|
| Parents/Caregivers — Female | 28 | 32 | 60 |
| Parents/Caregivers — Male | 5 | 0 | 5 |
| Patients — Female | 15 | 16 | 31 |
| Patients — Male | 18 | 16 | 34 |
| Race (NIH/OMB)(Participants) | Face-to-face Arm | TOBI Arm | Total |
|---|---|---|---|
| Parents/Caregivers — American Indian or Alaska Native | 0 | 0 | 0 |
| Parents/Caregivers — Asian | 0 | 0 | 0 |
| Parents/Caregivers — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Parents/Caregivers — Black or African American | 13 | 13 | 26 |
| Parents/Caregivers — White | 15 | 18 | 33 |
| Parents/Caregivers — More than one race | 0 | 0 | 0 |
| Parents/Caregivers — Unknown or Not Reported | 5 | 1 | 6 |
| Patients — American Indian or Alaska Native | 0 | 0 | 0 |
| Patients — Asian | 0 | 0 | 0 |
| Patients — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Patients — Black or African American | 13 | 13 | 26 |
| Patients — White | 15 | 18 | 33 |
| Patients — More than one race | 0 | 0 | 0 |
| Patients — Unknown or Not Reported | 5 | 1 | 6 |
| Region of Enrollment(participants) | Face-to-face Arm | TOBI Arm | Total |
|---|---|---|---|
| United States | 66 | 64 | 130 |
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