Designing Multimedia Patient Education for Adolescent Idiopathic Scoliosis

NCT ID: NCT06090344

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-30

Study Completion Date

2024-05-30

Brief Summary

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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:

* 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.

Detailed Description

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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.

Conditions

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Adolescent Idiopathic Scoliosis Patient Engagement

Keywords

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Scoliosis Multimedia Patient Education Health Education Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Usual care

Usual care from healthcare providers

Group Type NO_INTERVENTION

No interventions assigned to this group

Traditional video format

Multimedia videos formatted as traditionally found online

Group Type EXPERIMENTAL

Traditional video format

Intervention Type OTHER

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

Evidence-informed video format

Multimedia videos formatted as per evidence advice

Group Type EXPERIMENTAL

Evidence-informed video format

Intervention Type OTHER

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

Interventions

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Traditional video format

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

Intervention Type OTHER

Evidence-informed video format

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Garett Van Oirschot

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cailbhe Doherty, PhD, BSc

Role: STUDY_CHAIR

University College Dublin

Locations

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University College Dublin

Belfield, Dublin 4, Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type DERIVED
PMID: 38781168 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LS-23-15-VanOirschot-Doherty

Identifier Type: -

Identifier Source: org_study_id