Clinical trial NCT06090344: Designing Multimedia Patient Education for Adolescent Idiopathic Scoliosis
Official title: Designing Multimedia Patient Education Materials for Adolescent Idiopathic Scoliosis: a Feasibility Randomised Controlled Trial of Patient Education Videos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Patient Engagement
Keywords: Scoliosis
Multimedia
Patient Education
Health Education
Adolescent Idiopathic Scoliosis
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 46
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this triple-masked three-armed feasibility randomised controlled trial is to compare patient education materials for participants with adolescent idiopathic scoliosis. The main question it aims to answer are:

* Are educational videos superior to usual care?
* Are educational videos formatted in line with literature advice on multimedia design superior to videos formatted as traditionally found on scoliosis advisory websites Participants in the video groups will be asked to do view six educational videos and respond to a quiz. Researchers will compare the informed video group and traditional video group to usual care to see if there are differences in engagement, quality of life, physical activity and health-related anxiety.

Detailed description: Multimedia patient education materials are increasingly used in healthcare. This triple-masked three-armed feasibility randomised controlled trial will examine participants aged 10-18 with radiographically confirmed adolescent idiopathic scoliosis and their response to usual care or to receive multimedia educational videos with or without evidence-informed design principles. Primary outcomes will be patient knowledge measured by online quiz and engagement measured by YouTube analytics. Participants will be masked in the two video intervention arms, as will the therapist sending the educational videos. The results will outline the number of participants recruited and randomised, the number analysed post-intervention and at week eight, and the outcomes for baseline, post-intervention and week 8, which will include the effect size and level of precision. Adverse events will also be reported.

This feasibility randomised controlled trial will offer insight into the effectiveness of implementing advice from the literature in designing multimedia patient education materials for a population with adolescent idiopathic scoliosis.

Eligibility criteria: Inclusion Criteria:

* aged 10-18 years
* parent/guardian consent for those under 18 years of age
* adolescent Idiopathic Scoliosis (AIS) as confirmed by Cobb angle ≥10deg on plain film radiographs
* able to watch and listen to online educational materials as well as read and complete online surveys

Exclusion Criteria:

- scoliosis due to non-AIS conditions

Primary outcomes:
measure: Number recruited, rejected, randomised, dropped off, completed
timeFrame: Week 0,1,2,3,4,5,6,7,8
measure: Dropout reasons
timeFrame: Week 1,2,3,4,5,6,7,8
measure: Outcomes completed
timeFrame: Week 1,2,3,4,5,6,7,8
measure: Satisfaction with study procedures
timeFrame: Week 8
measure: Number and type of adverse events
timeFrame: Week 2,3,4,5,6,7,8
Secondary outcomes:
measure: Scoliosis Research Society 22-revised
timeFrame: Week 0, 8
measure: YouTube Average Watch Duration
timeFrame: Week 1,2,3,4,5,6
measure: Knowledge Translation
timeFrame: Week 1,2,3,4,5,6
measure: Knowledge Retention
timeFrame: Week 8
measure: YouTube Watch Percentage
timeFrame: Week 1,2,3,4,5,6,7,8
measure: YouTube Behavioural Engagement
timeFrame: Week 1,2,3,4,5,6,7,8
measure: YouTube Time to Complete
timeFrame: Week 1,2,3,4,5,6,7,8
measure: YouTube Visits
timeFrame: Week 1,2,3,4,5,6,7,8
measure: YouTube Affective Engagement
timeFrame: Week 1,2,3,4,5,6
measure: European Quality of Life 5-Dimension Youth Version
timeFrame: Week 0, 8
measure: Physical Activity Questionnaire - older Children
timeFrame: Week 0, 8
measure: State Trait Anxiety Index (Children)
timeFrame: Week 0, 8
Other outcomes:
Locations:
city: Belfield
country: Ireland
facility: University College Dublin
state: Dublin 4
Study officials:
affiliation: University College Dublin
name: Cailbhe Doherty, PhD, BSc
role: STUDY_CHAIR
References: