Clinical trial NCT05019144: Telemedicine Optimized Burn Intervention
Official title: A Novel Telemedicine Optimized Burn Intervention (TOBI) for Pediatric Burn-injured Patients and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Pediatric ALL
Keywords: Pediatrics
Telemedicine
Mobile health
Burns
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-08-24
Enrollment: 64
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who agree to participate in the study
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
measure: Percentage of participants retained in the study over time
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
measure: TOBI treatment fidelity
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
measure: Number of participants that experienced adverse events, serious adverse events, and unexpected problems
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
measure: Number of times problems with technology happened in the TOBI condition
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
Secondary outcomes:
measure: Number of days until wound is healed
timeFrame: Measured during the treatment phase (2-4 weeks)
measure: Treatment adherence
timeFrame: Measured during the treatment phase (2-4 weeks)
measure: Number of unscheduled ED/clinic and video visits
timeFrame: Measured during the treatment phase (2-4 weeks)
measure: Time to treatment of wound complication
timeFrame: Measured during the treatment phase (2-4 weeks)
measure: Patient-Reported Outcomes Measurement Information System - Sleep (PROMIS-Sleep) (4-item form) scores
timeFrame: Measured during the treatment phase (2-4 weeks)
measure: Patient-reported pain scores
timeFrame: Measured during the treatment phase (2-4 weeks)
measure: Caregiver's perception of child's pain scores
timeFrame: Measured during the treatment phase (2-4 weeks)
measure: Attitudes Towards Technology and Telemedicine Questionnaire
timeFrame: Measured at baseline and 1-month follow-up
measure: Perception of Healthcare Access
timeFrame: Measured at baseline and 1-month follow-up
measure: Positive And Negative Affect Schedule (PANAS) scores
timeFrame: Measured at baseline and 1-month follow-up
measure: Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) (4-item form) scores
timeFrame: Measured at baseline and 1-month follow-up
measure: Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) (4-item form) scores
timeFrame: Measured at baseline and 1-month follow-up
measure: Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) (4-item form) scores
timeFrame: Measured at baseline only
measure: Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) (4-item form) scores
timeFrame: Measured at baseline only
measure: Peritraumatic Distress Inventory (PDI) sores
timeFrame: Measured at baseline only
measure: Perceived Stress Scale (PSS) scores
timeFrame: Measured at 1-month follow-up only
measure: Posttraumatic Growth Inventory (PTGI) scores
timeFrame: Measured at 1-month follow-up only
measure: Client Satisfaction Questionnaire-8 (CSQ-8) scores
timeFrame: Measured at 1-month follow-up only
measure: mHealth App Usability Questionnaire (MAUQ) Scores
timeFrame: Measured at 1-month follow-up only
measure: Total number of face-to-face visits
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
measure: Total number of TOBI visits
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
measure: Total travel time
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
measure: Direct cost to patient/caregiver
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
measure: Time to return to work/school
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
measure: App metrics (TOBI condition only)
timeFrame: 24 months from the enrollment of the first participant or until the study number is reached
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: