Designing Multimedia Patient Education for Adolescent Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis Clinical Trial

— PEMAIS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06090344
• Other study ID #: LS-23-15-VanOirschot-Doherty
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: May 28, 2024

Study information

• Verified date: May 2024
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: May 28, 2024
• Est. primary completion date: May 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Patient Engagement
• Scoliosis

Intervention

Other:
• Traditional video format
6 x 3 minute videos designed in the same format as traditionally found on the internet
• Evidence-informed video format
6 x 3 minute videos designed in the format recommended by advice in the literature

Locations

Country	Name	City	State
Ireland	University College Dublin	Belfield	Dublin 4

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Dropout reasons	Participant reasons for dropping out (if provided)	Week 1,2,3,4,5,6,7,8
Primary	Outcomes completed	Percentage of outcomes completed	Week 1,2,3,4,5,6,7,8
Primary	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
Primary	Number and type of adverse events	Adverse events	Week 2,3,4,5,6,7,8
Secondary	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
Secondary	YouTube Average Watch Duration	Duration of video view	Week 1,2,3,4,5,6
Secondary	Knowledge Translation	5-item multiple choice quiz immediately after video watching	Week 1,2,3,4,5,6
Secondary	Knowledge Retention	40-item multiple choice quiz after 8 weeks	Week 8
Secondary	YouTube Watch Percentage	Watch time / Total time	Week 1,2,3,4,5,6,7,8
Secondary	YouTube Behavioural Engagement	Percent of time on specific segments	Week 1,2,3,4,5,6,7,8
Secondary	YouTube Time to Complete	Time relative to completion	Week 1,2,3,4,5,6,7,8
Secondary	YouTube Visits	Number of views for the video	Week 1,2,3,4,5,6,7,8
Secondary	YouTube Affective Engagement	Selecting thumbs up (like) or down (dislike) using like buttons	Week 1,2,3,4,5,6
Secondary	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
Secondary	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
Secondary	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