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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.
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online exercise program | Experimental | 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. |
|
| Standard of Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Education tool | Other | An online education tool that contains 4 modules |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment and eligbility | A recruitment rate of four eligible participants per month is targeted, with consent rate (eligible/consenting participants) calculated. | From recruitment until end of follow up at 6 weeks. |
| 7-point likert scale | 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. | From recruitment until end of follow up at 6 weeks. |
| Adherence and acceptability rate | >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. | From recruitment until end of follow-up at 6 weeks |
| Attrition rate | A maximum 20% attrition rate in either arm. | From recruitment until end of follow-up at 6 weeks |
| Data collection | With >85% of participants completing all outcome measures at six-week follow up targeted. | From recruitment until end of follow up at 6 weeks |
| NPRS scoring | An eleven-point numerical pain rating scale (NPRS) will assess worst pain in the past week. | From recruitment until end of follow up at 6 weeks. |
| EQ-5D-5L (EuroQol Group-5 dimensions-5 levels) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bradley Neal | Contact | 01473 704343 | R&D@esneft.nhs.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Suffolk and North Essex NHS Foundation Trust | Recruiting | Colchester | CO4 5JL | United Kingdom |
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| ID | Term |
|---|---|
| D046788 | Patellofemoral Pain Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
The reliable and responsive EQ-5D-5L will assess health-related quality of life. |
| From recruitment until end of follow up at 6 weeks. |