None listed
Conditions
Brief summary
This study aims to determine whether there is measurement equivalence between traditional paper-and-pen and electronic delivery of disease-specific patient-reported outcome measures (PROMs) in paediatric burn scar patients and their caregivers. Determining the equivalence of these delivery methods will provide evidence regarding the ability to transition from paper-based administration to electronic based administration of patient-reported outcome measures involving children and caregivers in research and clinical practice based on the comparability of psychometric properties and conceptual base of the measures. We hypothesise that there will be acceptable equivalence between pen-and-paper and electronic completion methods.
Interventions
Patients will be asked to answer the following patient-reported outcome measure questionnaires in addition to basic demographic information: the Brisbane Burn Scar Impact Profile (BBSIP), patient report on the Patient and Observer Scar Assessment Scale (POSAS) and a 0-10 scale for rating satisfaction with treatment. Participants will also be asked to answer questions relating to their daily technology use. Participants will be asked to complete the PROMs twice, with total completion time (includ
Patients will be asked to answer the following patient-reported outcome measure questionnaires in addition to basic demographic information: the Brisbane Burn Scar Impact Profile (BBSIP), patient report on the Patient and Observer Scar Assessment Scale (POSAS) and a 0-10 scale for rating satisfaction with treatment. Participants will also be asked to answer questions relating to their daily technology use. Participants will be asked to complete the PROMs twice, with total completion time (including the wait period) expected to take between 30 to 45 minutes. The delivery method of the questionnaires will be compared. Questionnaire delivery method and order will be randomised into four parallel arms; two treatment and two control arms. The treatment arms are: Arm 1 – Paper-Tablet Delivery: Patients will be asked to complete pen-and-paper copies of the questionnaires. On completion, participants will be asked to wait for a minimum of 10 minutes, before completing the questionnaires again, this time using a tablet (iPad). Participants will be timed as they complete the questionnaires. Arm 2 – Tablet-Paper Delivery: Patients will be presented with a tablet (iPad) to complete electronic copies of the questionnaires. Once complete, and after a minimum wait of 10 minutes, participants will be asked to complete the questionnaires again, this time using paper-and-pen methods. Participants will be timed as they complete the questionnaires Participants in both arms will be asked to complete 6 orientation questions before completing the questionnaires on the tablet to help them become familiar with answering questions on the tablet. Additional questions will ask participants to rate the usefulness of electronic PROM delivery and their preferences for paper-and-pen or electronic delivery. Participants will be monitored by researchers while completing the questionnaires as part of the 'time to complete' assessment. This will also allow participants to ask researchers questions about the questionnaires.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Caregivers of children with hypertrophic burn scars, and children aged over 8 years old with hypertrophic burn scarring. Participants must not have answered burn-scar specific patient-reported outcome measures within one month of attending clinic, using either electronic or pen-and-paper methods.
Exclusion criteria
Patients and parents who: - are unable to read and/or understand written English. - have a cognitive disorder or delay. - have a visual impairment that may impair their ability to complete the patient-reported outcome measure questionnaires. - have physical deformities that would impact their ability to write or use a technological device to complete the questionnaires
Outcome results
None listed