Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05791513
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-03-17
Brief Title:
The Effectiveness of Using a Clinical Support Tool in Managing Adolescents With Non-Traumatic Knee Pain
Sponsor:
Aalborg University
Organization:
Aalborg University
Study Overview
Official Title:
The Effectiveness of Using a Clinical Support Tool in Managing Adolescents With Non-Traumatic Knee Pain The MAP-Knee Trial a Stepped-wedge Cluster Randomised Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
MAP-Knee
Brief Summary:
The aim of the stepped-wedge cluster randomised trial is to investigate the effectiveness of using a clinical support tool The MAP-Knee Tool in managing adolescents aged 10-19 years with non-traumatic knee pain compared to not using the tool Six participating hospitals will start to use the tool within 4 6 or 8 months after recruitment start in a randomised order We will investigate if using the tool is superior in terms of reducing symptoms compared to not using the tool
Detailed Description:
The trial will be designed as a stepped-wedge cluster randomised superiority trial to be conducted across 6 hospital departments across Denmark Any orthopaedic or similar hospital department in Denmark to which adolescents suffering from non-traumatic knee pain may be referred is eligible for participation Any medical doctor or physiotherapist employed at either of the study sites who regularly see adolescents with non-traumatic knee pain will be eligible to participate in the trial
Before crossover occurs at the study site the adolescents will be treated as usual which is at the discretion of the treating clinician Based on our current research on the usual care pathway this will be heterogenous and include advice to wait and see imaging most often MRI and x-ray or a rehabilitation plan for the municipality After crossing over to using the MAP-Knee Tool the treating clinician will use the MAP-Knee Tool together with the adolescent The tool was designed to support the entire consultation from diagnosing the condition patellofemoral pain Osgood-Schlatter Sinding-Larsson-Johansson growth pain patellar tendinopathy or iliotibial band syndrome to deciding on future management The MAP-Knee Tool includes four separate components 1 a tool for diagnosing the most common types of non-traumatic knee pain SMILE 2 credible explanations of the aetiology and pathogenesis specific to the diagnosis based on multiple methods with an iterative design 3 a presentation of prognostic factors based on an individual participant data meta-analysis and 4 an option grid that presents the users of the tool with pros and cons of commonly used management options based on a systematic literature search of systematic and narrative reviews within non-traumatic adolescent knee pain An overarching focus of all components was to support shared decision-making and base decisions on all three pillars of evidence-based medicine patient values clinical expertise and relevant research Therefore the tool should not provide the users with definitive answers simply based on available evidence After the initial prototype of the tool including all four components had been made the investigators performed end-user testing using think-aloud sessions with adolescents suffering from non-traumatic knee pain adolescents with no history of knee pain and medical doctors
Before crossover occurs at the study site the adolescents will be treated as usual which is at the discretion of the treating clinician Based on our current research on the usual care pathway this will be heterogenous and include advice to wait and see imaging most often MRI and x-ray or a rehabilitation plan for the municipality After crossing over to using the MAP-Knee Tool the treating clinician will use the MAP-Knee Tool together with the adolescent The tool was designed to support the entire consultation from diagnosing the condition patellofemoral pain Osgood-Schlatter Sinding-Larsson-Johansson growth pain patellar tendinopathy or iliotibial band syndrome to deciding on future management The MAP-Knee Tool includes four separate components 1 a tool for diagnosing the most common types of non-traumatic knee pain SMILE 2 credible explanations of the aetiology and pathogenesis specific to the diagnosis based on multiple methods with an iterative design 3 a presentation of prognostic factors based on an individual participant data meta-analysis and 4 an option grid that presents the users of the tool with pros and cons of commonly used management options based on a systematic literature search of systematic and narrative reviews within non-traumatic adolescent knee pain An overarching focus of all components was to support shared decision-making and base decisions on all three pillars of evidence-based medicine patient values clinical expertise and relevant research Therefore the tool should not provide the users with definitive answers simply based on available evidence After the initial prototype of the tool including all four components had been made the investigators performed end-user testing using think-aloud sessions with adolescents suffering from non-traumatic knee pain adolescents with no history of knee pain and medical doctors
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None