Telemedicine Optimized Burn Intervention

Burns Clinical Trial

— TOBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05019144
• Other study ID #: Pro00109037
• Secondary ID: K23HD098328-01A1
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Burns
• Pediatric ALL

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