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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05019144
Other study ID # Pro00109037
Secondary ID K23HD098328-01A1
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date March 8, 2024

Study information

Verified date March 2024
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date March 8, 2024
Est. primary completion date March 8, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility Inclusion criteria: Participants will be eligible for enrollment if: 1. the patient (child) is < 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 burn is being treated with advanced burn dressing therapy (e.g., Silvadene™, Polysporin™, Acticoat™, Mepilex™, or Mepitel™); 4. the 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 patient/caregiver owns and is capable of using a smart device (an Android or iOS smartphone) with permission to download TOBI app from the Google Store or AppStore; 7. able to comply with outpatient clinic visits. Exclusion Criteria: - There are no exclusion criteria. All participants who meet inclusion criteria would be eligible to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Face-to-face burn care
If the participants are assigned to FTF care, they will receive standard burn care including a return follow-up in the burn clinic on a routine basis as prescribed by the clinical burn team (at least once per week) until the burn has healed.
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.

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants who agree to participate in the study Looking at the number of participants who agree to enroll in the study versus the total number of participants who are approached to participate in the study 24 months from the enrollment of the first participant or until the study number is reached
Primary Percentage of participants retained in the study over time Looking at the percentage or ratio of participants retained in the study versus those lost to attrition 24 months from the enrollment of the first participant or until the study number is reached
Primary TOBI treatment fidelity Looking at the percentage of TOBI providers' adherence to the treatment protocol. Will use a fidelity checklist at each visit. 24 months from the enrollment of the first participant or until the study number is reached
Primary Number of participants that experienced adverse events, serious adverse events, and unexpected problems Looking at the number of participants in each condition that experienced AE, SEA, and UPs. 24 months from the enrollment of the first participant or until the study number is reached
Primary Number of times problems with technology happened in the TOBI condition Looking at the number of times providers or participants experienced technological problems with TOBI 24 months from the enrollment of the first participant or until the study number is reached
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 Measured during the treatment phase (2-4 weeks)
Secondary Treatment adherence Looking at the number of deviations from the prescribed treatment Measured during the treatment phase (2-4 weeks)
Secondary Number of unscheduled ED/clinic and video visits Looking at the number of days participants had unscheduled visits Measured during the treatment phase (2-4 weeks)
Secondary Time to treatment of wound complication Looking at the amount of time between a wound complication (e.g., infection, conversion to deeper burn requiring surgery, conversion to deeper burn requiring a change in therapy) until treatment is sought Measured during the treatment phase (2-4 weeks)
Secondary Patient-Reported Outcomes Measurement Information System - Sleep (PROMIS-Sleep) (4-item form) scores Looking at average scores on the PROMIS-Sleep (4-item form) questionnaire (caregiver-reported) between the two conditions. Scores range from 4 to 20, with higher scores = greater sleep problems. Measured during the treatment phase (2-4 weeks)
Secondary Patient-reported pain scores Looking at average pain scores between the two conditions using the Wong-Baker Scale (0-10, with higher scores = more pain) Measured during the treatment phase (2-4 weeks)
Secondary Caregiver's perception of child's pain scores Looking at average pain scores between the two conditions using the caregivers' report (0-10 scale, with higher scores = more pain) Measured during the treatment phase (2-4 weeks)
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. Measured at baseline and 1-month follow-up
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. Measured at baseline and 1-month follow-up
Secondary Positive And Negative Affect Schedule (PANAS) scores Looking at the change in group average scores on the PANAS questionnaire measuring positive and negative affect (caregiver-reported). PANAS has two subscales - positive and negative affect. The scores on each subscale range between 10-50, with higher scores = higher levels of affect. Measured at baseline and 1-month follow-up
Secondary Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) (4-item form) scores Looking at the change in group average scores on the PROMIS-Depression (4-item form) questionnaire (caregiver-reported). Scores range between 4-20, with higher scores = more depression symptoms. Measured at baseline and 1-month follow-up
Secondary Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) (4-item form) scores Looking at the change in group average scores on the PROMIS-Anxiety (4-item form) questionnaire (caregiver-reported). Scores range between 4-20, with higher scores = more anxiety symptoms. Measured at baseline and 1-month follow-up
Secondary Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) (4-item form) scores Looking at average scores on the PROMIS-General-Self-Efficacy (4-item form) questionnaire (caregiver-reported). Scores range between 4-20, with higher scores = greater general self-efficacy. Measured at baseline only
Secondary Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) (4-item form) scores Looking at average scores on the PROMIS-Self-Efficacy-Manage-Emotions (4-item form) questionnaire (caregiver-reported). Scores range between 4-20, with higher scores = greater self-efficacy to manage emotions. Measured at baseline only
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. Measured at baseline only
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. Measured at 1-month follow-up only
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. Measured at 1-month follow-up only
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. Measured at 1-month follow-up only
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 average = higher usability of the app. Measured at 1-month follow-up only
Secondary Total number of face-to-face visits Looking at the total number of face-to-face visits 24 months from the enrollment of the first participant or until the study number is reached
Secondary Total number of TOBI visits Looking at the total number of TOBI visits 24 months from the enrollment of the first participant or until the study number is reached
Secondary Total travel time Looking at the total travel time in each condition 24 months from the enrollment of the first participant or until the study number is reached
Secondary Direct cost to patient/caregiver Looking at the direct cost to patient/caregiver 24 months from the enrollment of the first participant or until the study number is reached
Secondary Time to return to work/school Looking at the average time it took patient/caregiver to return to school/work 24 months from the enrollment of the first participant or until the study number is reached
Secondary App metrics (TOBI condition only) Looking at the TOBI app metrics (# of video-conferences, messages, & photos) 24 months from the enrollment of the first participant or until the study number is reached
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