Is Online Patient EducatioN Feasible in People With Patellofemoral Pain Whilst They Wait for Physiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment and eligbility
研究概览
简要总结
The primary aim is to determine if online patient education is a feasible intervention for people with PFP awaiting physiotherapy. The secondary aim is to provide outcome data to inform a future substantiative trial.
详细描述
Participants will take part in a feasibility trial whilst they are on the ESNEFT physiotherapy waiting list to avoid disrupting their routine care.
Participants will first attend a face-to-face eligibility assessment to validate their diagnosis of PFP, before being randomised to one of two arms:
- The online education arm will be provided with password access to our online patient education platform (https://www.teampfp.com/my-knee-cap-pain) that contains four modules; [a] Understand your pain; [b] How do I start to exercise; [c] Treatment options; [d] Case studies. The aim of each module is to provide people with knowledge they can put into practice (experiential learning) and facilitating their self-management. A short quiz at the end of each module assesses user engagement and knowledge retention.
Investigators developed these modules alongside members of the International Patellofemoral Research Network, and people with PFP that attended a PPI event at Queen Mary University London (QMUL) that aimed to understand what information people with PFP wanted to help them self-manage their condition.
Participants randomised to the online education group will be instructed to consume the content at their own pace (with one module/week advised) and that their adherence will be determined by monitoring their completion of each end of module quiz. Participants with no access to a device or the internet, will be given a paper version. 2. The control arm will receive no additional care whilst on the ESNEFT physiotherapy waiting list. Their involvement in the trial will end at six-weeks follow up and they will then be provided with access to the online education platform if they request it.
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
- Single (Investigator)
盲法说明
The Prinicipal Investigator of the study will be blinded to all individual participant information and only have access to unique pseudonymised study numbers/ data and which group they are assigned too.
入排标准
- 年龄范围
- 16 Years 至 44 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-44 years
- •Gradual onset retro-and/or peri-patellar pain
- •Symptoms reproduced during one or more of running; jumping; stair ambulation; squatting
- •Referred to East Suffolk and North Essex NHS Foundation Trust for outpatient physiotherapy at Colchester hospital
- •Able to read and understand written/spoken English
排除标准
- •Aged 45 years and older
- •Symptoms of concomitant knee pathology
- •Symptoms commencing after trauma or knee surgery
- •Presentation inconsistent with patellofemoral pain during clinical examination
- •Unable to understand written/spoken English
- •Unable to give informed consent
研究组 & 干预措施
Online exercise program
The online education arm will be provided with password access to our online patient education platform (https://www.teampfp.com/my-knee-cap-pain) that contains four modules; [a] Understand your pain; [b] How do I start to exercise; [c] Treatment options; [d] Case studies. The aim of each module is to provide people with knowledge they can put into practice (experiential learning) and facilitating their self-management. A short quiz at the end of each module assesses user engagement and knowledge retention.
干预措施: Online Education tool (Other)
Standard of Care
The control arm will receive no additional care whilst on the ESNEFT physiotherapy waiting list. Their involvement in the trial will end at six-weeks follow up and they will then be provided with access to the online education platform if they request it.
结局指标
主要结局
Recruitment and eligbility
时间窗: From recruitment until end of follow up at 6 weeks.
A recruitment rate of four eligible participants per month is targeted, with consent rate (eligible/consenting participants) calculated.
7-point likert scale
时间窗: From recruitment until end of follow up at 6 weeks.
We will use the 7-point Likert global rating of change (GROC) scale with categories: \[1\] much better, \[2\] better, \[3\] a little better, \[4\] no change, \[5\] a little worse \[6\] much worse, and \[7\] markedly worse. Successful outcome will be dichotomised and defined a priori as \[1\] much better or \[2\] better.
Adherence and acceptability rate
时间窗: From recruitment until end of follow-up at 6 weeks
\>75% of participants in the online education arm attempting the end of education module quizzes and acceptability meaningfully greater than remaining on a waiting list.
Attrition rate
时间窗: From recruitment until end of follow-up at 6 weeks
A maximum 20% attrition rate in either arm.
Data collection
时间窗: From recruitment until end of follow up at 6 weeks
With \>85% of participants completing all outcome measures at six-week follow up targeted.
NPRS scoring
时间窗: From recruitment until end of follow up at 6 weeks.
An eleven-point numerical pain rating scale (NPRS) will assess worst pain in the past week.
EQ-5D-5L (EuroQol Group-5 dimensions-5 levels)
时间窗: From recruitment until end of follow up at 6 weeks.
The reliable and responsive EQ-5D-5L will assess health-related quality of life.
次要结局
未报告次要终点