Effectiveness of a Mobile App for Individuals With or at Risk of Knee Osteoarthritis

Not Applicable

• Conditions: Digital Health; Knee Pain/Osteoarthritis
• Interventions: Device: mRehab app; Device: Sham app

• Registration Number: NCT04199416
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06
• Study Start: 2021-01-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mRehab app	mRehab app	Participants randomized to the intervention group will be given the mRehab app free of charge to perform self-management of their knees in their homes.
Sham app	Sham app	Participants randomized to the control group will receive a sham app free of charge to perform self-management of their knees in their homes.

Primary Outcome Measures

Name	Time	Method
Changes in knee pain	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	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).

Secondary Outcome Measures

Name	Time	Method
Changes in lower limb function	from baseline to 3, 6, 9, and 12 months	Lower limb function will be assessed by a 40-m fast-paced walking test, a 9-step stair-climb test, a five-repetition sit-to-stand test, active and passive ranges of motion of the hip and knee joints, and the mini-balance evaluation system test (mini-BESTest).
Changes in lower limb muscle strength	from baseline to 3, 6, 9, and 12 months	Maximal isometric strength of the quadriceps and hamstrings will be assessed by a handheld dynamometer.
Changes in health-related physical activity	from baseline to 3, 6, 9, and 12 months	Health-related physical activity will be assessed using the Chinese version of international physical activity questionnaire. This questionnaire asks participants to report the frequency and duration of walking, all vigorous and moderate activities lasting at least 10 min, plus time spent in sedentary activity (sitting and lying awake) during the past 7 days. The data were converted to metabolic equivalent scores for each type of activity, with higher score indicating more physical activity.
Changes in self-efficacy for coping with knee problems	from baseline to 3, 6, 9, and 12 months	Self-efficacy will be assessed using a 5-item self-efficacy scale modified from an existing validated scale, with scores ranging from 1 (not at all confident) to 10 (totally confident).
Changes in health-related quality of life	from baseline to 3, 6, 9, and 12 months	Health-related quality of life will be measured using the Chinese version of the EuroQoL 5-dimension 5-level (EQ-5D-5L) questionnaire, which consists of the EuroQoL 5-dimension (EQ-5D) descriptive system and the EQ visual analogue scale (VAS). The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension is rated on a 3-point scale (i.e., no problems, some problems, and extreme problems). The EQ VAS asks the subject to indicate his or her health state on a vertical, visual analog scale with end points of 0 (worst imaginable health state) and 100 (best imaginable health state).

Trial Locations

Locations (3)

New Territories East Cluster, Hospital Authority; 🇭🇰 Hong Kong, Hong Kong

Hong Kong West Cluster, Hospital Authority; 🇭🇰 Hong Kong, Hong Kong

Hong Kong East Cluster, Hospital Authority; 🇭🇰 Hong Kong, Hong Kong