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Completed

NCT Number: NCT06090344

Designing Multimedia Patient Education for Adolescent Idiopathic Scoliosis

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis Adherence Interventions Behavior Bone Diseases Health Behavior Health Education Medication Adherence Musculoskeletal Diseases Patient Acceptance of Health Care Patient Compliance Patient Engagement Patient Participation Scoliosis Spinal Curvatures Spinal Diseases Treatment Adherence and Compliance

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Belfield, Dublin 4, D04 V1W8, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional video format

Other

6 x 3 minute videos designed in the same format as traditionally found on the internet

Evidence-informed video format

Other

6 x 3 minute videos designed in the format recommended by advice in the literature

Primary outcomes

  1. Number recruited, rejected, randomised, dropped off, completed

    Time frame: Week 0,1,2,3,4,5,6,7,8

    Number of participants enrolled at each stage of recruitment, rejection, randomisation, during study, and upon completion

  2. Dropout reasons

    Time frame: Week 1,2,3,4,5,6,7,8

    Participant reasons for dropping out (if provided)

  3. Outcomes completed

    Time frame: Week 1,2,3,4,5,6,7,8

    Percentage of outcomes completed

  4. Satisfaction with study procedures

    Time frame: Week 8

    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

  5. Number and type of adverse events

    Time frame: Week 2,3,4,5,6,7,8

    Adverse events

Secondary outcomes

  1. Scoliosis Research Society 22-revised

    Time frame: Week 0, 8

    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.

  2. YouTube Average Watch Duration

    Time frame: Week 1,2,3,4,5,6

    Duration of video view

  3. Knowledge Translation

    Time frame: Week 1,2,3,4,5,6

    5-item multiple choice quiz immediately after video watching

  4. Knowledge Retention

    Time frame: Week 8

    40-item multiple choice quiz after 8 weeks

  5. YouTube Watch Percentage

    Time frame: Week 1,2,3,4,5,6,7,8

    Watch time / Total time

  6. YouTube Behavioural Engagement

    Time frame: Week 1,2,3,4,5,6,7,8

    Percent of time on specific segments

  7. YouTube Time to Complete

    Time frame: Week 1,2,3,4,5,6,7,8

    Time relative to completion

  8. YouTube Visits

    Time frame: Week 1,2,3,4,5,6,7,8

    Number of views for the video

  9. YouTube Affective Engagement

    Time frame: Week 1,2,3,4,5,6

    Selecting thumbs up (like) or down (dislike) using like buttons

  10. European Quality of Life 5-Dimension Youth Version

    Time frame: Week 0, 8

    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.

  11. Physical Activity Questionnaire - older Children

    Time frame: Week 0, 8

    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.

  12. State Trait Anxiety Index (Children)

    Time frame: Week 0, 8

    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.

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Official study title

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

Acronym: PEMAIS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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