Effectiveness of a Mobile App for Individuals With or at Risk of Knee Osteoarthritis
NCT ID: NCT04199416
Last Updated: 2020-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
320 participants
INTERVENTIONAL
2021-01-01
2023-03-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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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.
mRehab app
The mRehab app will be an interactive system with a user-friendly graphical user interface to provide multiple motivational functions that engage individuals in their prescribed home exercises. The app will contain video-based lower limb strengthening and aerobic exercise materials, health information, and motivational functions to increase their access to rehabilitation and care resources to augment their self-management ability.
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.
Sham app
The sham app will only contain educational components and text-based exercise recommendations.
Interventions
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mRehab app
The mRehab app will be an interactive system with a user-friendly graphical user interface to provide multiple motivational functions that engage individuals in their prescribed home exercises. The app will contain video-based lower limb strengthening and aerobic exercise materials, health information, and motivational functions to increase their access to rehabilitation and care resources to augment their self-management ability.
Sham app
The sham app will only contain educational components and text-based exercise recommendations.
Eligibility Criteria
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Inclusion Criteria
* a regular smartphone user,
* able to speak Cantonese and read Chinese,
* able to perform the exercises required in the physical assessments,
* able to provide written informed consent.
* with subnormal quadriceps strength (as defined by the inability to complete five repetitions of a sit-to-stand test in less than 8 seconds \[50 to 70 years of age\], 10 seconds \[70 to 79 years of age\], or 12 seconds \[80 years or older\])
* with significant chronic knee pain (i.e., ≥2/10 on the 11-point Numerical Pain Rating Scale for more than 3 months on most days of the previous month, aggravated by weight-bearing or movement)
* without regular medical follow-up for knee problems
* with symptomatic radiographic KOA and being followed-up in hospitals
* have radiographic evidence of grade 2 to 3 KOA on the Kellgren-Lawrence scale in the posteroanterior and/or skyline view or the presence of lateral/posterior osteophytes.
Exclusion Criteria
* have nonambulatory status,
* have systemic inflammatory arthritis (e.g., gout),
* have a history of knee or hip replacement surgery,
* have a history of trauma or surgical arthroscopy of either knee within the past 6 months,
* involve in a similar study,
* participate in a knee exercise program within the past 6 months,
* have an intra-articular injection to the knee within the past 3 months,
* have recent or imminent surgery (within 3 months),
* have medical co-morbidities that preclude participation in exercise
50 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Dr. Calvin Or
Associate professor
Locations
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Hong Kong East Cluster, Hospital Authority
Hong Kong, , Hong Kong
Hong Kong West Cluster, Hospital Authority
Hong Kong, , Hong Kong
New Territories East Cluster, Hospital Authority
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Yin Chun Loretta YAM
Role: primary
Ping-keung CHAN, PhD
Role: primary
Kevin Ki-wai HO, PhD
Role: primary
References
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Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
Zhang Y, Xu L, Nevitt MC, Aliabadi P, Yu W, Qin M, Lui LY, Felson DT. Comparison of the prevalence of knee osteoarthritis between the elderly Chinese population in Beijing and whites in the United States: The Beijing Osteoarthritis Study. Arthritis Rheum. 2001 Sep;44(9):2065-71. doi: 10.1002/1529-0131(200109)44:93.0.CO;2-Z.
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
Lee QJ, Mak WP, Wong YC. Mortality following primary total knee replacement in public hospitals in Hong Kong. Hong Kong Med J. 2016 Jun;22(3):237-41. doi: 10.12809/hkmj154712. Epub 2016 May 6.
Oiestad BE, Juhl CB, Eitzen I, Thorlund JB. Knee extensor muscle weakness is a risk factor for development of knee osteoarthritis. A systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Feb;23(2):171-7. doi: 10.1016/j.joca.2014.10.008. Epub 2014 Nov 1.
Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
Bennell KL, Nelligan R, Dobson F, Rini C, Keefe F, Kasza J, French S, Bryant C, Dalwood A, Abbott JH, Hinman RS. Effectiveness of an Internet-Delivered Exercise and Pain-Coping Skills Training Intervention for Persons With Chronic Knee Pain: A Randomized Trial. Ann Intern Med. 2017 Apr 4;166(7):453-462. doi: 10.7326/M16-1714. Epub 2017 Feb 21.
Case MA, Burwick HA, Volpp KG, Patel MS. Accuracy of smartphone applications and wearable devices for tracking physical activity data. JAMA. 2015 Feb 10;313(6):625-6. doi: 10.1001/jama.2014.17841. No abstract available.
Yingyongyudha A, Saengsirisuwan V, Panichaporn W, Boonsinsukh R. The Mini-Balance Evaluation Systems Test (Mini-BESTest) Demonstrates Higher Accuracy in Identifying Older Adult Participants With History of Falls Than Do the BESTest, Berg Balance Scale, or Timed Up and Go Test. J Geriatr Phys Ther. 2016 Apr-Jun;39(2):64-70. doi: 10.1519/JPT.0000000000000050.
Bohannon RW, Bubela DJ, Magasi SR, Wang YC, Gershon RC. Sit-to-stand test: Performance and determinants across the age-span. Isokinet Exerc Sci. 2010;18(4):235-240. doi: 10.3233/IES-2010-0389.
KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
Or C, Tao D. A 3-Month Randomized Controlled Pilot Trial of a Patient-Centered, Computer-Based Self-Monitoring System for the Care of Type 2 Diabetes Mellitus and Hypertension. J Med Syst. 2016 Apr;40(4):81. doi: 10.1007/s10916-016-0437-1. Epub 2016 Jan 22.
Other Identifiers
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HMRF 17181291
Identifier Type: -
Identifier Source: org_study_id