Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-27 @ 4:24 PM
Study NCT ID:
NCT06744257
Status:
RECRUITING
Last Update Posted:
2025-01-23
First Post:
2024-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Online Patient EducatioN Feasible in People With Patellofemoral Pain Whilst They Wait for Physiotherapy
Sponsor:
East Suffolk and North Essex NHS Foundation Trust
Organization:
Study Overview
Official Title:
Is Online Patient EducatioN Feasible in People With Patellofemoral Pain Whilst They Wait for Physiotherapy
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPEN
Brief Summary:
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.
Detailed Description:
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:
1. 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.
The feasibility outcomes, adapted from those used in recent trials and mapped to trial quality appraisal scales, are designed to inform us on the willingness of clinicians to recruit participants, the willingness of participants to be randomised, if participants will accept and adhere to patient education intervention, if sufficient data can be collected, and potential effects of online education. Outcomes informing intervention effects have been optimised after discussion with participants from two pre-trial PPI focus groups. Outcome measures will be collected using the good data protection regulations (GDPR) compliant REDCap system (https://www.project-redcap.org/). Participants will receive regular prompts and paper versions with stamped/addressed envelopes will be available to those who are digitally illiterate, supported by a research assistant.
1. Recruitment and eligibility; a recruitment rate of four eligible participants per month is targeted, with consent rate (eligible/consenting participants) calculated
2. Randomisation and blinding; broad equality of baseline characteristics between groups and acceptable outcome assessor blinding will be targeted
3. Adherence and acceptability; \>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
4. A maximum 20% attrition rate in either arm
5. Data collection; with \>85% of participants completing all outcome measures at six-week follow up targeted.
6. The 7-point Likert global rating of change (GROC) scale will be used to allow comparison to recent RCTs involving people with PFP. Categories will be: \[1\] 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 at six-weeks follow up.
7. An eleven-point numerical pain rating scale (NPRS) will assess worst pain in the past week, which is valid and responsive in people with PFP 9.
8. The reliable and responsive EQ-5D-5L will assess health-related quality of life; important for future cost-effectiveness analyses 16. The final question of EQ-5D-5L relates to anxiety/depression. If participants select severely or extremely anxious or depressed, the investigators will inform the participant's GP.
Investigators will invite a subset of participants randomised to the online education arm to participate in a maximum of two semi-structured focus groups (n=6 per group) or 1:1 interviews post-trial. The aim of these focus groups will be to explore their perspectives on participating in our feasibility trial and receiving our online patient education intervention. Investigators will specifically explore the factors that affected if participants felt they had benefitted from receiving online patient education, and whether further physiotherapy input was still required. These semi-structured focus groups will be conducted by co-applicant Dr Katharine Fowler.
Participants will first attend a face-to-face eligibility assessment to validate their diagnosis of PFP, before being randomised to one of two arms:
1. 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.
The feasibility outcomes, adapted from those used in recent trials and mapped to trial quality appraisal scales, are designed to inform us on the willingness of clinicians to recruit participants, the willingness of participants to be randomised, if participants will accept and adhere to patient education intervention, if sufficient data can be collected, and potential effects of online education. Outcomes informing intervention effects have been optimised after discussion with participants from two pre-trial PPI focus groups. Outcome measures will be collected using the good data protection regulations (GDPR) compliant REDCap system (https://www.project-redcap.org/). Participants will receive regular prompts and paper versions with stamped/addressed envelopes will be available to those who are digitally illiterate, supported by a research assistant.
1. Recruitment and eligibility; a recruitment rate of four eligible participants per month is targeted, with consent rate (eligible/consenting participants) calculated
2. Randomisation and blinding; broad equality of baseline characteristics between groups and acceptable outcome assessor blinding will be targeted
3. Adherence and acceptability; \>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
4. A maximum 20% attrition rate in either arm
5. Data collection; with \>85% of participants completing all outcome measures at six-week follow up targeted.
6. The 7-point Likert global rating of change (GROC) scale will be used to allow comparison to recent RCTs involving people with PFP. Categories will be: \[1\] 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 at six-weeks follow up.
7. An eleven-point numerical pain rating scale (NPRS) will assess worst pain in the past week, which is valid and responsive in people with PFP 9.
8. The reliable and responsive EQ-5D-5L will assess health-related quality of life; important for future cost-effectiveness analyses 16. The final question of EQ-5D-5L relates to anxiety/depression. If participants select severely or extremely anxious or depressed, the investigators will inform the participant's GP.
Investigators will invite a subset of participants randomised to the online education arm to participate in a maximum of two semi-structured focus groups (n=6 per group) or 1:1 interviews post-trial. The aim of these focus groups will be to explore their perspectives on participating in our feasibility trial and receiving our online patient education intervention. Investigators will specifically explore the factors that affected if participants felt they had benefitted from receiving online patient education, and whether further physiotherapy input was still required. These semi-structured focus groups will be conducted by co-applicant Dr Katharine Fowler.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: