Collaborative Model of Care Between Orthopaedics and Allied Healthcare Professionals Trial (CONnACT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcomes Score (KOOS4)
研究概览
简要总结
Osteoarthritis knee is the leading cause of chronic disability among older adults. Our current model of care is doctor-centric and inefficient leading to suboptimal use of allied health intervention for effective lifestyle and behaviour changes resulting in potentially, unnecessary surgery.
The study is designed using an effectiveness-implementation hybrid study design utilizing a mixed methods approach. The hybrid study has dual aims. The primary aim is to evaluate the clinical effectiveness (pain, function and quality of life) of a 12-week multidisciplinary (Orthopaedics, Physiotherapy, Dietetics, Psychology) personalized, community-based program for patients with knee osteoarthritis through a randomized-controlled trial. The secondary aim is to obtain data that will inform the context for implementation and guide future wider scale application. The investigators hypothesize that this multidisciplinary program is clinically more effective in the treatment of knee osteoarthritis at 12 months compared to standard care.
详细描述
BACKGROUND With a rapidly aging population, osteoarthritis is expected to become the 4th leading cause of global disability by 2020. Established guidelines for knee osteoarthritis strongly advocate lifestyle changes, such with exercises and weight loss as first line of treatment, whilst reserving surgery as the last resort. Our current model of care is doctor-centric and inefficient leading to suboptimal use of allied health intervention for effective lifestyle and behaviour changes resulting in potentially, unnecessary surgery. Redesigning the model of care by moving away from costly surgical treatment through the optimization and synergizing of proven non-surgical treatments is key to deliver value-based care.
AIMS AND HYPOTHESIS Primary Aim and Hypothesis. Evaluate the clinical effectiveness (pain, function and quality of life) at 12 months of a personalized, community based 3-month multidisciplinary program (Orthopaedics, Physiotherapist, Dietitian and Psychologist) as compared with usual care for patients with knee osteoarthritis. The investigators hypothesize that patients with knee osteoarthritis who undergo a personalized, community based 3-month multidisciplinary program will have better pain, function and quality of life scores at 12 months post initiation of program compared to patients who undergo usual care.
Secondary Aim. Evaluate the cost effectiveness of a personalized, community based 3-month multidisciplinary program (Orthopaedic, Physiotherapist, Dietitian and Psychologist) for patients with knee osteoarthritis. Qualitative assessment of the acceptability, feasibility and scalability of such a program
METHODOLOGY The study will be conducted as a single centre, single-blinded, gender stratified, block permutated randomized controlled trial using a mixed method approach (quantitative and qualitative), comparing a proposed new multidisciplinary personalized community-based model of care and the current model of care.
Patients with suspected knee osteoarthritis who are referred from the Polyclinics in the primary healthcare setting to the Tan Tock Seng Hospital Orthopaedic Specialist Outpatient Clinic. Patients will then be evaluated based on the inclusion and exclusion criteria and subsequently invited to join the study if eligible. Consent for participation into the study will be obtained prior to randomization. Randomization will be done via gender stratified permutated block randomization.
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
- 45 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •National Institute for Health and Care Excellence (NICE) clinical criteria for knee osteoarthritis
- •Radiographic severity of knee osteoarthritis - Kellgren Lawrence Score > 1
- •Knee Injury and Osteoarthritis Outcome Score (KOOS4) ≤ 75
- •Independent community ambulator with or without walking aid
- •Age ≥ 45 years old
- •Conversant in English/Chinese
- •Subject will need to fulfill all the inclusion criteria for eligibility.
排除标准
- •Alternative diagnosis to knee osteoarthritis e.g. referred pain from the spine or hip
- •Secondary arthritis e.g. inflammatory, post-traumatic
- •Inability to comply with study protocol e.g. cognitive impairment
- •Previous knee arthroplasty on the symptomatic knee
- •Wheelchair bound patients
- •Any other medical condition that study team determines may interfere with study involvement
结局指标
主要结局
Knee Injury and Osteoarthritis Outcomes Score (KOOS4)
时间窗: Assessed at baseline, 3 months, 6 months, 12 months
Change in disease specific pain and functional outcome scores between patients undergoing the multidisciplinary community program and the current model of care will be evaluated. A composite score of the following subscales will be calculated using the averaged score - Pain, Symptoms, Activities of Daily Living and Quality of Life will be calculated. Scores between 0 and 100 represent the percentage of total possible score achieved, with zero representing extreme knee problems and 100 representing no knee problems.
次要结局
- Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Symptoms, Activities of Daily Living, Sports/Recreational Activities, Quality of Life(Assessed at baseline, 3 months, 6 months, 12 months)
- Total Knee Replacement(Assessed at 3 months, 6 months, 12 months)
- Functional Assessment - 40m fast-paced walk test(Assessed at baseline, 3 months, 6 months, 12 months)
- Patient Activation Measure (PAM)(Assessed at baseline, 3 months, 6 months, 12 months)
- Functional Assessment - 30s chair stand test(Assessed at baseline, 3 months, 6 months, 12 months)
- Patient Health Questionnaire 4 (PHQ-4)(Assessed at baseline, 3 months, 6 months, 12 months)
- EuroQol-5 Dimensions (EQ-5D)(Assessed at baseline, 3 months, 6 months, 12 months)
- Functional Assessment - 4 stairs climb test(Assessed at baseline, 3 months, 6 months, 12 months)
- Functional Assessment - Timed up and go test(Assessed at baseline, 3 months, 6 months, 12 months)
- Pain, Enjoyment, General Activity Scale (PEG)(Assessed at baseline, 3 months, 6 months, 12 months)
- Body Mass Index (BMI)(Assessed at baseline, 3 months, 6 months, 12 months)
研究者
Bryan Tan
Senior Resident
Tan Tock Seng Hospital