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

NCT04199416 | Unknown

• 1 other identifier: HMRF 17181291
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 3

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.

Conditions

Knee Pain/Osteoarthritis; Digital Health

Outcome Measures

Primary Outcomes (2)

• Changes in knee pain

  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.

  from baseline to 3, 6, 9, and 12 months

• Changes in physical function of the knee

  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).

  from baseline to 3, 6, 9, and 12 months

Secondary Outcomes (5)

• 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

Study Arms (2)

mRehab app

EXPERIMENTAL

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.

Device: mRehab app

Sham app

SHAM COMPARATOR

Participants randomized to the control group will receive a sham app free of charge to perform self-management of their knees in their homes.

Device: Sham app

Interventions

mRehab app DEVICE

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.

mRehab app

Sham app DEVICE

The sham app will only contain educational components and text-based exercise recommendations.

Sham app

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 50 years of age,
• 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.

You may not qualify if:

• have a cognitive impairment,
• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (3)

Hong Kong East Cluster, Hospital Authority

Hong Kong, Hong Kong

Location

Hong Kong West Cluster, Hospital Authority

Hong Kong, Hong Kong

Location

New Territories East Cluster, Hospital Authority

Hong Kong, Hong Kong

Location

Related Publications (12)

• 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.

  PMID: 24553908 BACKGROUND

• 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.

  PMID: 11592368 BACKGROUND

• 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.

  PMID: 17403800 BACKGROUND

• 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.

  PMID: 27149975 BACKGROUND

• 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.

  PMID: 25450853 BACKGROUND

• 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.

  PMID: 26405113 BACKGROUND

• 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.

  PMID: 28241215 BACKGROUND

• 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.

  PMID: 25668268 BACKGROUND

• 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.

  PMID: 25794308 BACKGROUND

• 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.

  PMID: 25598584 BACKGROUND

• 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.

  PMID: 13498604 BACKGROUND

• 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.

  PMID: 26802011 BACKGROUND

Central Study Contacts

Kalun Or, PhD

CONTACT

852-39172587; klor@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 13, 2019
• Study Start: January 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)