Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06195423
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-12-22
Brief Title:
Stopping OsteoARthritis After an ACL Tear
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
The Stop Osteoarthritis SOAR Hybrid Effectiveness-Implementation Type 1 Randomized Controlled Trial for Young People At-High-Risk of Early Onset Knee Osteoarthritis
Status:
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:
SOAR
Brief Summary:
By 2040 25 of Canadians will have osteoarthritis a disabling joint condition Most people think osteoarthritis only affects older adults but 50 of the 700000 Canadian youth who hurt their knee playing sports annually will develop osteoarthritis by 40 years of age These young people with old knees face knee pain and disability for much of their adult lives interfering with parenting work and recreation Yet most do not know about osteoarthritis or how to reduce their risk
In this clinical trial people who have torn the Anterior Cruciate ligament in their knee and had reconstruction surgery 9-36 months previously will be randomized to receive either a 6-month virtual education and exercise therapy program called Stop OsteoARthritis SOAR or a minimal intervention control program Researchers will test if those who received the SOAR program have larger gains in knee health including pain symptoms function and quality of life at 6 12 and 24 months Researchers will also use MRIs baseline and 24 months to assess how the SOAR program influences knee cartilage degeneration and its cost-effectiveness
In this clinical trial people who have torn the Anterior Cruciate ligament in their knee and had reconstruction surgery 9-36 months previously will be randomized to receive either a 6-month virtual education and exercise therapy program called Stop OsteoARthritis SOAR or a minimal intervention control program Researchers will test if those who received the SOAR program have larger gains in knee health including pain symptoms function and quality of life at 6 12 and 24 months Researchers will also use MRIs baseline and 24 months to assess how the SOAR program influences knee cartilage degeneration and its cost-effectiveness
Detailed Description:
PURPOSE Assess the effectiveness efficiency and implementation of a 6-month evidence-informed digital online education and exercise-therapy program SOAR - Stop OsteoARthritis versus a minimal intervention control for people aged 16-35 years at risk of early-onset knee osteoarthritis OA due to a first time Anterior Cruciate Ligament Reconstruction ACLR
OBJECTIVES
Primary Effectiveness Objective Assess if self-reported knee pain symptoms function and QoL average of the Knee injury and OA Outcome Score pain other symptoms function in sport and recreation and quality of life subscale scores KOOS4 of people at risk of knee OA who receive SOAR is superior to those receiving a minimal intervention CONTROL at 6 primary end-point 12 and 24 months
Primary Efficiency Objective Assess the incremental cost-utility ratio of SOAR compared CONTROL 6 12 24 months
Primary Implementation Objective Assess provider adoption of the SOAR program
Secondary Effectiveness Objectives
1 Assess if the perceived self-management of people at risk of knee OA who receive SOAR is superior to those receiving a minimal intervention CONTROL 6 12 24 months
2 Assess if the percentage of SOAR group participants who achieve a Patient Acceptable Symptom State PASS for knee-related pain other symptoms function in daily living function in sport and recreation and quality of life is superior to CONTROL 6 12 24 months
3 Assess if knee OA MRI features of SOAR group participants are superior to CONTROL 24 months
Secondary Efficiency Objectives
1 Describe the health resource use of SOAR and CONTROL participants 24 months
2 Describe SOAR program delivery costs
Secondary Implementation Objectives
1 Describe provider perceived barriers and facilitators of SOAR delivery
2 Describe participants perceived barriers and facilitators of SOAR delivery
3 Describe features of physiotherapy PT counseling that promote self-management
Exploratory Effectiveness Objectives Explore the superiority of SOAR to CONTROL on the following outcomes at 6 12 and 24 months
1 Patient-specific function
2 Knee-related self-efficacy
3 Knee-related fear of movement and re-injury
4 Knee extensor strength
5 Knee flexor strength
6 Physical activity
7 Health-related quality-of-life
8 Adiposity
9 Early cartilage degeneration at 24 months only
RESEARCH DESIGN
The proposed trial is a two-arm assessor-blinded superiority hybrid effectiveness-implementation type 1 randomized controlled trial with embedded cost-utility analyses and 11 interviews This multi-focus design effectiveness implementation efficacy can accelerate research translation to real-world settings Type 1 main focus-intervention effectiveness secondary focus-understand implementation context This design is appropriate as we have shown feasibility and indirect evidence of SOAR effect the intervention is minimal risk and there are no fully powered superiority trials to inform non-inferiority or equivalence designs
The nature of the interventions do not allow for full blinding physiotherapists cannot be blinded to treatment We will employ proven methods from our proof-of-concept RCT to reduce allocation online randomization module with schedule prepared by an arms-length statistician and confirmation bias outcome assessors and data analysts will be blinded to allocation
STATISTICAL ANALYSES
Primary analyses will be intent-to-treat by randomization Data missing more than 5 will be imputed using multiple imputations by chained equations to avoid bias To ensure best practice all outcome and demographicprognostic variables will be included in imputation equations
Demographics Descriptive statistics will be calculated for demographic and potentially prognostic variables time since injury and ACLR concomitant injury ACLR rehabilitation graft type reinjury co-intervention SES and observed differences considered or controlled for when interpreting findings
Effectiveness SOAR superiority will be assessed with a generalized linear mixed regression model GLMM for the primary outcome KOOS4 at 6 months adjusted for baseline measure time since ACLR and sex Adjusting for continuous time since ACLR versus stratifying improves power Similar GLMMs will assess SOAR superiority for continuous secondary PIH and exploratory knee extensor strength adiposity physical activity outcomes at stated time points Mixed effect logistic regression models adjusted for the same variables as GLMMs will assess SOAR superiority for binary secondary outcomes MRI lesion worsening achieving PASS at stated time points Analyses will yield valid results under the missing at random MAR assumption The robustness of estimates to potential MAR assumption violations will be assessed with state-of-art methods
SexGender To explore the effect of gender identity women man gender-diverse and sex female male intersex on outcome variables and intervention effect all outcomes will be described by treatment group stratified by gender KOOS4 Partner in Health Scale cost-utility physical activity quality of life or sex MRI knee extensor strength adiposity at all time points We will estimate GLMMs and report intervention effect estimates stratified by sex female male or gender woman man as exploratory analyses to inform future studies As 6 of our preliminary proof-of-concept randomized controlled trial participants identified gender diverse descriptive statistics will also explore differences by cis and diverse gender
Implementation The of physiotherapists achieving 85 on the fidelity checklist and checklist items with 70 fidelity will be reported Provider and participants responses to survey questions asking about barriers and facilitators of SOAR implementation will be summarized Interview recordings related to identifying features of participant-provider interactions that facilitate self-management will be transcribed and de-identified Data will be coded using a constant comparative approach and categories will be developed by comparing and identifying meaningful patterns across codes High-order themes will elucidate the relationship between categories We will look for uniqueness by gender and if found reanalyze the data with a gender lens Analysis trustworthiness and credibility will be fostered through data immersion memoing reflexive journaling and team discussions An audit of analytic decisions will be kept
Efficiency outcome Incremental cost-utility ratio will be estimated as Cost_SOAR - Cost_CONTROL QALY_SOAR - QALY_CONTROL for the intervention and 6-month post-intervention period using nested imputation and nonparametric bootstrapping to model uncertainty around cost and QALY estimates The contribution of each cost item to total healthcare resource use will be described by group gender and compliance full partial
OBJECTIVES
Primary Effectiveness Objective Assess if self-reported knee pain symptoms function and QoL average of the Knee injury and OA Outcome Score pain other symptoms function in sport and recreation and quality of life subscale scores KOOS4 of people at risk of knee OA who receive SOAR is superior to those receiving a minimal intervention CONTROL at 6 primary end-point 12 and 24 months
Primary Efficiency Objective Assess the incremental cost-utility ratio of SOAR compared CONTROL 6 12 24 months
Primary Implementation Objective Assess provider adoption of the SOAR program
Secondary Effectiveness Objectives
1 Assess if the perceived self-management of people at risk of knee OA who receive SOAR is superior to those receiving a minimal intervention CONTROL 6 12 24 months
2 Assess if the percentage of SOAR group participants who achieve a Patient Acceptable Symptom State PASS for knee-related pain other symptoms function in daily living function in sport and recreation and quality of life is superior to CONTROL 6 12 24 months
3 Assess if knee OA MRI features of SOAR group participants are superior to CONTROL 24 months
Secondary Efficiency Objectives
1 Describe the health resource use of SOAR and CONTROL participants 24 months
2 Describe SOAR program delivery costs
Secondary Implementation Objectives
1 Describe provider perceived barriers and facilitators of SOAR delivery
2 Describe participants perceived barriers and facilitators of SOAR delivery
3 Describe features of physiotherapy PT counseling that promote self-management
Exploratory Effectiveness Objectives Explore the superiority of SOAR to CONTROL on the following outcomes at 6 12 and 24 months
1 Patient-specific function
2 Knee-related self-efficacy
3 Knee-related fear of movement and re-injury
4 Knee extensor strength
5 Knee flexor strength
6 Physical activity
7 Health-related quality-of-life
8 Adiposity
9 Early cartilage degeneration at 24 months only
RESEARCH DESIGN
The proposed trial is a two-arm assessor-blinded superiority hybrid effectiveness-implementation type 1 randomized controlled trial with embedded cost-utility analyses and 11 interviews This multi-focus design effectiveness implementation efficacy can accelerate research translation to real-world settings Type 1 main focus-intervention effectiveness secondary focus-understand implementation context This design is appropriate as we have shown feasibility and indirect evidence of SOAR effect the intervention is minimal risk and there are no fully powered superiority trials to inform non-inferiority or equivalence designs
The nature of the interventions do not allow for full blinding physiotherapists cannot be blinded to treatment We will employ proven methods from our proof-of-concept RCT to reduce allocation online randomization module with schedule prepared by an arms-length statistician and confirmation bias outcome assessors and data analysts will be blinded to allocation
STATISTICAL ANALYSES
Primary analyses will be intent-to-treat by randomization Data missing more than 5 will be imputed using multiple imputations by chained equations to avoid bias To ensure best practice all outcome and demographicprognostic variables will be included in imputation equations
Demographics Descriptive statistics will be calculated for demographic and potentially prognostic variables time since injury and ACLR concomitant injury ACLR rehabilitation graft type reinjury co-intervention SES and observed differences considered or controlled for when interpreting findings
Effectiveness SOAR superiority will be assessed with a generalized linear mixed regression model GLMM for the primary outcome KOOS4 at 6 months adjusted for baseline measure time since ACLR and sex Adjusting for continuous time since ACLR versus stratifying improves power Similar GLMMs will assess SOAR superiority for continuous secondary PIH and exploratory knee extensor strength adiposity physical activity outcomes at stated time points Mixed effect logistic regression models adjusted for the same variables as GLMMs will assess SOAR superiority for binary secondary outcomes MRI lesion worsening achieving PASS at stated time points Analyses will yield valid results under the missing at random MAR assumption The robustness of estimates to potential MAR assumption violations will be assessed with state-of-art methods
SexGender To explore the effect of gender identity women man gender-diverse and sex female male intersex on outcome variables and intervention effect all outcomes will be described by treatment group stratified by gender KOOS4 Partner in Health Scale cost-utility physical activity quality of life or sex MRI knee extensor strength adiposity at all time points We will estimate GLMMs and report intervention effect estimates stratified by sex female male or gender woman man as exploratory analyses to inform future studies As 6 of our preliminary proof-of-concept randomized controlled trial participants identified gender diverse descriptive statistics will also explore differences by cis and diverse gender
Implementation The of physiotherapists achieving 85 on the fidelity checklist and checklist items with 70 fidelity will be reported Provider and participants responses to survey questions asking about barriers and facilitators of SOAR implementation will be summarized Interview recordings related to identifying features of participant-provider interactions that facilitate self-management will be transcribed and de-identified Data will be coded using a constant comparative approach and categories will be developed by comparing and identifying meaningful patterns across codes High-order themes will elucidate the relationship between categories We will look for uniqueness by gender and if found reanalyze the data with a gender lens Analysis trustworthiness and credibility will be fostered through data immersion memoing reflexive journaling and team discussions An audit of analytic decisions will be kept
Efficiency outcome Incremental cost-utility ratio will be estimated as Cost_SOAR - Cost_CONTROL QALY_SOAR - QALY_CONTROL for the intervention and 6-month post-intervention period using nested imputation and nonparametric bootstrapping to model uncertainty around cost and QALY estimates The contribution of each cost item to total healthcare resource use will be described by group gender and compliance full partial
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