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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Usual care from healthcare providers | |
| Traditional video format | Experimental | Multimedia videos formatted as traditionally found online |
|
| Evidence-informed video format | Experimental | Multimedia videos formatted as per evidence advice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional video format | Other | 6 x 3 minute videos designed in the same format as traditionally found on the internet |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
- scoliosis due to non-AIS conditions
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| Name | Affiliation | Role |
|---|---|---|
| Cailbhe Doherty, PhD, BSc | University College Dublin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Dublin | Belfield | Dublin 4 | D04 V1W8 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38781168 | Derived | Van Oirschot G, Doherty C. Designing multimedia patient education materials for adolescent idiopathic scoliosis: A protocol for a feasibility randomized controlled trial of patient education videos. PLoS One. 2024 May 23;19(5):e0297394. doi: 10.1371/journal.pone.0297394. eCollection 2024. |
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All anonymised data will be available for viewing on OSF
Available from 2025 when data is expected to be compiled and written up and submitted for publication
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
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2023 | Oct 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| D012600 | Scoliosis |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Evidence-informed video format | Other | 6 x 3 minute videos designed in the format recommended by advice in the literature |
|
| 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 |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |