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临床试验/NCT04942236
NCT04942236尚未招募不适用

Collaborative Model of Care Between Orthopaedics and Allied Health Care Professionals (CONNACT) OA Knee Cohort

Tan Tock Seng Hospital3 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
3
主要终点
Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)

研究概览

简要总结

CONNACT OA knee cohort is a prospective longitudinal cohort study where we aim to collect sociodemographic, psychosocial, clinical, health utilization and cost data in order to better understand the Asian OA knee cohort and investigate for prognostic variables that can potentially influence a patients clinical outcome and treatment decisions.

In addition, the CONNACT OA knee cohort will form the basis for a cohort multiple randomized control trial (cmRCT) study design where multiple interventions can be tested in a randomized fashion. Each intervention is offered to a randomly selected sample of patients eligible for that intervention, who are then compared with the rest of the eligible patients from the cohort that are still being treated as usual.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
46 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Knee Osteoarthritis (based on NICE guidelines)
  • Age > 45 years
  • Community ambulator with or without walking aid
  • Conversant in English or Chinese

排除标准

  • Alternative diagnosis to Knee OA e.g. referred pain from spine or hip
  • Other forms of knee arthritis e.g. inflammatory, post-traumatic
  • Moderate to severe cognitive impairment e.g. dementia
  • Previous knee arthroplasty
  • Wheelchair bound patients
  • Medical conditions that will medically interfere with rehabilitation involvement e.g. decompensated heart failure, stroke with significant deficit, end stage renal failure

结局指标

主要结局

Knee Injury and Osteoarthritis Outcomes Score (KOOS-12)

时间窗: Change from Baseline to 12 months

Derived from the original 42-item Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact. The KOOS sub scales are scored using the method of summated ratings and transformed to range from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problem. The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. It also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.

次要结局

  • Knee Injury and Osteoarthritis Outcomes Score (KOOS) subscales - Pain, Function, QoL(Change from Baseline to 12 months)
  • Patient Health Questionnaire 4 (PHQ-4)(Change from Baseline to 12 months)
  • EuroQol-5 Dimensions (EQ-5D)(Change from Baseline to 12 months)
  • Pain, Enjoyment, General Activity Scale (PEG)(Change from Baseline to 12 months)

研究者

发起方
Tan Tock Seng Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bryan Tan

Associate Consultant

Tan Tock Seng Hospital

研究点 (3)

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