Adolescent Idiopathic ScoliosisPEMAISNCT06090344
Designing Multimedia Patient Education for Adolescent Idiopathic Scoliosis
A study testing Traditional video format and Evidence-informed video format in people with Adolescent Idiopathic Scoliosis and Patient Engagement, run by University College Dublin at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Patient Engagement
- What is being tested?
- Traditional video format and Evidence-informed video format
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIreland
- Study dates
- 30 Jan 2024to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- scoliosis due to non-AIS conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Designing Multimedia Patient Education Materials for Adolescent Idiopathic Scoliosis: a Feasibility Randomised Controlled Trial of Patient Education Videos
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.
Read the detailed 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.
- Being tested
- Traditional video format, Evidence-informed video format
- Keywords
- Scoliosis, Multimedia, Patient Education, Health Education, Adolescent Idiopathic Scoliosis
- Medical subject headings
- Patient Participation, Scoliosis, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional video formatOther
6 x 3 minute videos designed in the same format as traditionally found on the internet
Evidence-informed video formatOther
6 x 3 minute videos designed in the format recommended by advice in the literature
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual care from healthcare providers |
| Traditional video format | Experimental | Multimedia videos formatted as traditionally found online Receives: Other: Traditional video format |
| Evidence-informed video format | Experimental | Multimedia videos formatted as per evidence advice Receives: Other: Evidence-informed video format |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number recruited, rejected, randomised, dropped off, completed
Number of participants enrolled at each stage of recruitment, rejection, randomisation, during study, and upon completion
Measured: Week 0,1,2,3,4,5,6,7,8
Dropout reasons
Participant reasons for dropping out (if provided)
Measured: Week 1,2,3,4,5,6,7,8
Outcomes completed
Percentage of outcomes completed
Measured: 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
Measured: Week 8
Number and type of adverse events
Adverse events
Measured: Week 2,3,4,5,6,7,8
Secondary outcomes (12)
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.
Measured: Week 0, 8
YouTube Average Watch Duration
Duration of video view
Measured: Week 1,2,3,4,5,6
Knowledge Translation
5-item multiple choice quiz immediately after video watching
Measured: Week 1,2,3,4,5,6
Knowledge Retention
40-item multiple choice quiz after 8 weeks
Measured: Week 8
YouTube Watch Percentage
Watch time / Total time
Measured: Week 1,2,3,4,5,6,7,8
YouTube Behavioural Engagement
Percent of time on specific segments
Measured: Week 1,2,3,4,5,6,7,8
YouTube Time to Complete
Time relative to completion
Measured: Week 1,2,3,4,5,6,7,8
YouTube Visits
Number of views for the video
Measured: Week 1,2,3,4,5,6,7,8
YouTube Affective Engagement
Selecting thumbs up (like) or down (dislike) using like buttons
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start30 Jan 2024
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garett Van Oirschot, University College Dublin
- Investigators
- Cailbhe Doherty, PhD, BSc, Study chair, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090344
- Sponsor's protocol ID
- LS-23-15-VanOirschot-Doherty
- Acronym
- PEMAIS
- Status last verified
- Dec 2024
- First submitted
- 9 Oct 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymised data will be available for viewing on OSF
Publications
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.
PubMed 38781168
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing Multimedia Patient Education Materials for Adolescent Idiopathic Scoliosis: a Feasibility Randomised Controlled Trial of Patient Education Videos
- ClinicalTrials.gov ID
- NCT06090344
- Acronym / sponsor ID
- PEMAIS / LS-23-15-VanOirschot-Doherty
- Keywords
- Scoliosis, Multimedia, Patient Education, Health Education, Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care from healthcare providers |
| Traditional video format | Experimental | Other: Traditional video formatMultimedia videos formatted as traditionally found online |
| Evidence-informed video format | Experimental | Other: Evidence-informed video formatMultimedia videos formatted as per evidence advice |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- scoliosis due to non-AIS conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional video format6 x 3 minute videos designed in the same format as traditionally found on the internet | Other | Traditional video format |
| Evidence-informed video format6 x 3 minute videos designed in the format recommended by advice in the literature | Other | Evidence-informed video format |
Primary outcome
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
Dropout reasons
Time frame: Week 1,2,3,4,5,6,7,8
Participant reasons for dropping out (if provided)
Outcomes completed
Time frame: Week 1,2,3,4,5,6,7,8
Percentage of outcomes completed
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
Number and type of adverse events
Time frame: Week 2,3,4,5,6,7,8
Adverse events
12 secondary outcomes
Scoliosis Research Society 22-revised
Time frame: Week 0, 8
YouTube Average Watch Duration
Time frame: Week 1,2,3,4,5,6
Knowledge Translation
Time frame: Week 1,2,3,4,5,6
Knowledge Retention
Time frame: Week 8
YouTube Watch Percentage
Time frame: Week 1,2,3,4,5,6,7,8
YouTube Behavioural Engagement
Time frame: Week 1,2,3,4,5,6,7,8
YouTube Time to Complete
Time frame: Week 1,2,3,4,5,6,7,8
YouTube Visits
Time frame: Week 1,2,3,4,5,6,7,8
YouTube Affective Engagement
Time frame: Week 1,2,3,4,5,6
European Quality of Life 5-Dimension Youth Version
Time frame: Week 0, 8
Physical Activity Questionnaire - older Children
Time frame: Week 0, 8
State Trait Anxiety Index (Children)
Time frame: Week 0, 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 38781168Van 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.
- Individual participant dataSharing planned: Yes. All anonymised data will be available for viewing on OSF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cailbhe Doherty, PhD, BSc study chair
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional video format and Evidence-informed video format in people with Adolescent Idiopathic Scoliosis and Patient Engagement, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number recruited, rejected, randomised, dropped off, completed (time frame: Week 0,1,2,3,4,5,6,7,8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.