Designing Multimedia Patient Education for Adolescent Idiopathic Scoliosis

NCT06090344 | Completed

• 1 other identifier: LS-23-15-VanOirschot-Doherty
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis; Patient Engagement

Keywords

Scoliosis; Multimedia; Patient Education; Health Education; Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• Scoliosis Research Society 22-revised

  Week 0, 8

• YouTube Average Watch Duration

  Week 1,2,3,4,5,6

• Knowledge Translation

  Week 1,2,3,4,5,6

• Knowledge Retention

  Week 8

• YouTube Watch Percentage

  Week 1,2,3,4,5,6,7,8

Study Arms (3)

Usual care

NO INTERVENTION

Usual care from healthcare providers

Traditional video format

EXPERIMENTAL

Multimedia videos formatted as traditionally found online

Other: Traditional video format

Evidence-informed video format

EXPERIMENTAL

Multimedia videos formatted as per evidence advice

Other: Evidence-informed video format

Interventions

Traditional video format OTHER

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

Traditional video format

Evidence-informed video format OTHER

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

Evidence-informed video format

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- scoliosis due to non-AIS conditions

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

University College Dublin

Belfield, Dublin 4, D04 V1W8, Ireland

Location

Related Publications (1)

• 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.

  PMID: 38781168 DERIVED

MeSH Terms

Conditions

Patient Participation; Scoliosis; Health Education

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Adherence Interventions; Medication Adherence; Patient Compliance

Study Officials

• Cailbhe Doherty, PhD, BSc

  University College Dublin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 19, 2023
• Study Start: January 30, 2024
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available from 2025 when data is expected to be compiled and written up and submitted for publication
• 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

Locations

IE (1)