Designing Multimedia Patient Education Materials for Adolescent Idiopathic Scoliosis: a Feasibility Randomised Controlled Trial of Patient Education Videos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Number recruited, rejected, randomised, dropped off, completed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •scoliosis due to non-AIS conditions
结局指标
主要结局
Number recruited, rejected, randomised, dropped off, completed
时间窗: 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
时间窗: Week 1,2,3,4,5,6,7,8
Participant reasons for dropping out (if provided)
Satisfaction with study procedures
时间窗: 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
Outcomes completed
时间窗: Week 1,2,3,4,5,6,7,8
Percentage of outcomes completed
Number and type of adverse events
时间窗: Week 2,3,4,5,6,7,8
Adverse events
次要结局
- Scoliosis Research Society 22-revised(Week 0, 8)
- 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)
- YouTube Visits(Week 1,2,3,4,5,6,7,8)
- YouTube Average Watch Duration(Week 1,2,3,4,5,6)
- YouTube Behavioural Engagement(Week 1,2,3,4,5,6,7,8)
- YouTube Time to Complete(Week 1,2,3,4,5,6,7,8)
- YouTube Affective Engagement(Week 1,2,3,4,5,6)
- European Quality of Life 5-Dimension Youth Version(Week 0, 8)
- State Trait Anxiety Index (Children)(Week 0, 8)
- Physical Activity Questionnaire - older Children(Week 0, 8)
研究者
Garett Van Oirschot
Principal Investigator
University College Dublin