Designing Multimedia Patient Education for Adolescent Idiopathic Scoliosis (PEMAIS)

Designing Multimedia Patient Education Materials for Adolescent Idiopathic Scoliosis: a Feasibility Randomised Controlled Trial of Patient Education Videos

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.

Study Overview

• Status: Completed
• Conditions: Patient Engagement; Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Other: Traditional video format; Other: Evidence-informed video format

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin 4
    • Belfield, Dublin 4, Ireland, D04 V1W8
      • University College Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Usual care from healthcare providers
Experimental: Traditional video format; Multimedia videos formatted as traditionally found online	Other: Traditional video format; 6 x 3 minute videos designed in the same format as traditionally found on the internet
Experimental: Evidence-informed video format; Multimedia videos formatted as per evidence advice	Other: Evidence-informed video format; 6 x 3 minute videos designed in the format recommended by advice in the literature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number recruited, rejected, randomised, dropped off, completed	Number of participants enrolled at each stage of recruitment, rejection, randomisation, during study, and upon completion	Week 0,1,2,3,4,5,6,7,8
Dropout reasons	Participant reasons for dropping out (if provided)	Week 1,2,3,4,5,6,7,8
Outcomes completed	Percentage of outcomes completed	Week 1,2,3,4,5,6,7,8
Satisfaction with study procedures	Patient response to tailored question about satisfaction with intervention & study process. Question will read "How satisfied were you with the study process?" and participants will score on a 5-point scale with 1 being Very Unsatisfied and 5 being Very Satisfied	Week 8
Number and type of adverse events	Adverse events	Week 2,3,4,5,6,7,8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scoliosis Research Society 22-revised	Scoliosis Research Society 22-item revised questionnaire of health-related quality of life. The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The maximum score in each domain is 5 and minimum score is 1, with higher scores representing greater patient quality of life.	Week 0, 8
YouTube Average Watch Duration	Duration of video view	Week 1,2,3,4,5,6
Knowledge Translation	5-item multiple choice quiz immediately after video watching	Week 1,2,3,4,5,6
Knowledge Retention	40-item multiple choice quiz after 8 weeks	Week 8
YouTube Watch Percentage	Watch time / Total time	Week 1,2,3,4,5,6,7,8
YouTube Behavioural Engagement	Percent of time on specific segments	Week 1,2,3,4,5,6,7,8
YouTube Time to Complete	Time relative to completion	Week 1,2,3,4,5,6,7,8
YouTube Visits	Number of views for the video	Week 1,2,3,4,5,6,7,8
YouTube Affective Engagement	Selecting thumbs up (like) or down (dislike) using like buttons	Week 1,2,3,4,5,6
European Quality of Life 5-Dimension Youth Version	The EQ-5D-Y descriptive system comprises the following five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems. A higher score indicates higher quality of health.	Week 0, 8
Physical Activity Questionnaire - older Children	Physical Activity Questionnaire for older Children is a a seven-day recall self-administered questionnaire to evaluate moderately to vigorous physical activity in child. A higher score indicates a higher level of physical activity.	Week 0, 8
State Trait Anxiety Index (Children)	State Trait Anxiety Index for Children is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety.	Week 0, 8

Collaborators and Investigators

• Sponsor: University College Dublin
• Investigators: Study Chair: Cailbhe Doherty, PhD, BSc, University College Dublin

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Scoliosis; Health Education; Patient Education; Adolescent Idiopathic Scoliosis; Multimedia
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: LS-23-15-VanOirschot-Doherty

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All anonymised data will be available for viewing on OSF
• IPD Sharing Time Frame: Available from 2025 when data is expected to be compiled and written up and submitted for publication
• IPD Sharing Access Criteria: All those with the Open Science Framework link will be able to access the anonymised patient data on the project's Open Science Framework page
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No