The Stop Osteoarthritis (SOAR) Hybrid Effectiveness-Implementation Type 1 Randomized Controlled Trial for Young People At-High-Risk of Early Onset Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- Incremental cost-utility ratio over 6 months (efficiency outcome)
研究概览
简要总结
By 2040, 25% of Canadians will have osteoarthritis, a disabling joint condition. Most people think osteoarthritis only affects older adults, but 50% of the 700,000 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.
详细描述
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.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently live in British Columbia, Canada
- •16-35 years of age (inclusive)
- •9-36-months past a first-time ACLR performed ≤12-months of first-time ACL tear
- •Currently not receiving knee care from a health or fitness provider and have no scheduled surgical procedures (any part of the body) that would interfere with exercise during the study.
- •Score below a KOOS4 PASS (<79 points)
- •Have daily access to an email address and a computer with internet
- •Are willing to wear an activity tracker during the study
排除标准
- •Inability to communicate in English
- •No medical attention (healthcare provider) time-loss (missed physical activity, sport or work ≥2 occasions) injury to the ACLR knee before the ACL tear
- •Previous physician diagnosis of index knee osteoarthritis
- •Inflammatory arthritis or other systemic condition
- •Lower limb injury, surgery, or intra-articular injection in the past 6-months
- •Current pregnancy
- •MRI contraindications (i.e., Weight over 400 lbs (MRI machine limit); Pacemaker or any other implanted medical device (i.e., wires, defibrillator, artificial heart valve, an electronic device like a drug infusion pump, electrical stimulator for nerves or bones, coil, catheter, or filter in any blood vessel, ear or eye implant, or stainless steel intrauterine device (IUD); Brain or ferromagnetic aneurysm clip; any other metallic prostheses or shrapnel, bullets, or other metal fragments; injury where a piece of metal lodged in the eye or orbit, or; surgery, medical procedure or tattoos (including tattooed eyeliner) in the last 6 weeks).
结局指标
主要结局
Incremental cost-utility ratio over 6 months (efficiency outcome)
时间窗: Incremental cost-utility ratio at 6 months
To assess SOARs value for money (health systems perspective) we will estimate the incremental cost/mean change in Quality-Adjusted Life Years (QALY) gained by SOAR versus CONTROL at 6 months. Costs will be estimated with the Health Resource Utilization questionnaire (HRU) as the study population often uses resources not captured in administrative data and evidence of good agreement between administrative and prospectively collected HRU data. The HRU captures provider visits, hospital admissions, lab and diagnostic tests and medication use. QALYs will be estimated from health-related quality of life (EQ-5D-5L) using area under the curve analysis. The EQ-5D-5L is widely used for cost-utility analyses in OA, and assesses 5 levels across 5 health domains to produce a health state profile using Canadian conversion tariffs.
Self-reported knee-related pain, symptoms, function in sport and quality of life over 6 months (effectiveness outcome) (ACL tear participants)
时间窗: Change from baseline KOOS score at 6 months (ACL tear participants)
Patient partners identify pain, function and quality of life, which can be impaired up to 10-years post-ACLR, as priority outcomes. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a valid and reliable patient-reported outcome measure (PROM) with sub-scales for knee pain (9-items), other symptoms (7-items), function in daily living (ADL; 17-items), function in sport/recreation (5-items), and quality of life (4-items) across injury and OA populations. Each subscale item is scored on a 5-point scale and individual subscale items summed and transformed to a 0-100 scale with higher scores indicating better outcome. The KOOS4 which is an average of 4 sub-scales (excluding ADL) is a recommended and accepted primary outcome for ACLR RCTs and was responsive in our proof of concept RCT.
Provider adoption of SOAR over 6 months (implementation outcome) (physiotherapist participants)
时间窗: Percent fidelity at 6 months (physiotherapist participants)
A 40-item fidelity checklist, refined in our proof-of-concept RCT, will be applied to all video-recorded 1:1 counseling sessions for 4 participants per PT, and the median % fidelity for each PT and checklist item reported. Items reaching ≤70% will be identified and inform the development of PT training modules to facilitate future evaluation and implementation.
次要结局
- Patient Acceptable Symptom State over 6 months (ACL tear participants)(Change from baseline patient acceptable symptom state score at 6 months (ACL tear participants))
- Intervention delivery costs over 6 months(Intervention delivery costs over 6 months)
- Participant perceived barriers and facilitators of program delivery over 6 months (ACL tear participants)(Follow-up surveys will take place at 6 months (ACL tear participants))
- Provider perceived barriers and facilitators of program delivery over 6 months (physiotherapist participants)(Follow-up surveys will take place at 6 months (physiotherapist participants))
- Osteoarthritis MRI features over 24 months (ACL tear participants)(Change from baseline MRI at 24 months (ACL tear participants))
- Health resource use costs over 24 months(Health resource use costs over 24 months)
- Self-reported perceived self-management over 6 months (ACL tear participants)(Change from baseline self-reported perceived self-management at 6 months (ACL tear participants))
- Features of PT counselling that promote self-management over 6 months (ACL tear participants)(1:1 interviews will be conducted at 6 months (ACL tear participants))
研究者
Jackie Whittaker
Associate Professor
University of British Columbia