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临床试验/NCT04199416
NCT04199416Unknown不适用

Effectiveness of an Interactive, Multi-functional Mobile App-based Technology in Endogenous Healthcare for Individuals With or at Risk of Knee Osteoarthritis: A 12-month Randomized Controlled Trial

The University of Hong Kong3 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
320
试验地点
3
主要终点
Changes in knee pain

研究概览

简要总结

To develop and examine an interactive, multi-functional mobile app-based technology designed to encourage endogenous health care using a 12-month randomized controlled trial to demonstrate whether knee osteoarthritis (KOA)-at-risk individuals and KOA-diagnosed patients can improve their knee pain, physical function, and other relevant outcomes by using the technology to support knee/KOA self-management.

详细描述

Knee osteoarthritis (KOA), the most common degenerative condition affecting the peripheral weight-bearing joints, leads to pain, restricted mobility, and financial and moral burden. These effects will increase with rising numbers of incidents, exacerbated by population aging and obesity. Zhang et al. found KOA in 43% and 22% (15% and 6% in symptomatic individuals) of Chinese women and men, respectively, 60 years or older. In the United States, KOA affects 12% of the elderly population, and it is projected that the need for total knee replacement (TKR) to treat end-stage KOA will grow by 673% to 3.48 million procedures a year from 2005 to 2030, with the demand for TKR revision doubling from 2005 to 2015. Hong Kong's public hospitals performed 6658 TKRs from 2011 to 2014, with 10,000 cases wait-listed for 2016. These figures suggest that KOA will impose significant and increasing pressure on Hong Kong's healthcare system.

As quadriceps muscle weakness increases the risk of KOA, its symptoms should be alleviated by leg muscle strengthening. Land-based exercise has been effective under close monitoring and supervision. A recent Cochrane Review involving 54 studies concluded that there is moderate to high-quality evidence that land-based exercises significantly improve muscle strength, physical function, and quality of life and reduce pain in KOA patients. The effect of such exercises is comparable to that of nonsteroidal anti-inflammatory drugs with no significant adverse effects. However, therapist-delivered exercise is costly and often impractical, especially in a public-health context, and Internet-delivered exercise regimes represent an alternative approach. In today's information technology (IT)-enabled environment, mobile apps are readily accessible to users of untethered devices (e.g., smartphones). The "any-where, any-time" mobile IT could be exploited to more effectively manage KOA by encouraging self-motivation to substitute for direct monitoring. This study will present "IT-centered endogenous healthcare" as a public policy to boost self-help in primary care and test its practicability and efficacy in KOA management in Hong Kong. The word "endogenous" suggests that self-motivation is a form of self-insurance in primary care. It is further suggested that demand-side incentives will be needed to induce individuals to incrementally allocate more resources (particularly time and effort) to incrementally self-insure health at the primary level.

On the supply side, IT-based healthcare products have been mainly designed for commercial considerations such as marketing and are insufficiently focused on function for purposes of public health and policy. We follow Liao-Cheung's approach to reify demand-side incentives in the form of a publicly funded (and hence free) mobile app, the adoption of which could encourage self-insurance among individuals with knee problems or KOA. The users' time and effort will initially be rewarded by the app's user-friendliness and lack of a fee. The study's technology intervention, "mobile rehabilitation (mRehab) app", will link smartphones to videos of evidence-based, physiotherapist-prescribed exercises to alleviate knee/KOA symptoms, together with educational (e.g., diet and behavioral modifications) and motivational components. This mobile IT platform will have easier and wider accessibility than exercises delivered via tethered devices (e.g., desktop computers), and it can engage the users' interest whenever and wherever KOA effects are felt. Over time, self-motivation is also enhanced by high-frequency prompts, periodic upgrades with feedback, support from Internet KOA-awareness groups, the possibility of accumulating one's own health-data to facilitate queries and dialogue, and (most importantly) monitoring the health progression predicted by the exercise regimen.

A natural research sample follows in the form of IT-enabled individuals with knee/KOA problems. The proposed hypothesis is then offered that sustained use of the mRehab app will significantly reduce the symptoms and improve functions of individuals with quadriceps weakness and knee pain or KOA over time and compared to a sham app (the analytical control). The effectiveness of the mRehab app regarding this hypothesis will be tested in two samples: (1) KOA-at-risk individuals and (2) KOA-diagnosed patients, in a randomized controlled trial (RCT).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Changes in knee pain

时间窗: from baseline to 3, 6, 9, and 12 months

Knee pain will be assessed on a 11-point Numerical Pain Rating Scale, with 0 representing no pain and 10 representing the worst possible pain.

Changes in physical function of the knee

时间窗: from baseline to 3, 6, 9, and 12 months

Physical function will be measured with the 17-item physical function for daily living subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). A 5-point Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems).

次要结局

  • Changes in lower limb function(from baseline to 3, 6, 9, and 12 months)
  • Changes in lower limb muscle strength(from baseline to 3, 6, 9, and 12 months)
  • Changes in health-related physical activity(from baseline to 3, 6, 9, and 12 months)
  • Changes in self-efficacy for coping with knee problems(from baseline to 3, 6, 9, and 12 months)
  • Changes in health-related quality of life(from baseline to 3, 6, 9, and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Calvin Or

Associate professor

The University of Hong Kong

研究点 (3)

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