Evaluation of a digital platform for osteoarthritis treatment: study protocol for a randomised clinical study

Håkan Nero, Jonas Ranstam, Aliasghar Ahmad Kiadaliri, Leif E Dahlberg, Håkan Nero, Jonas Ranstam, Aliasghar Ahmad Kiadaliri, Leif E Dahlberg

Abstract

Introduction: Despite favourable results from structured face-to-face treatment of osteoarthritis (OA) in Sweden through the Better management of patients with OsteoArthritis (BOA) initiative, only around 20% of people with knee or hip OA receive the primary treatment recommended by international guidelines (ie, information, exercise, weight management). In 2014, a digital treatment programme named Joint Academy was introduced in Sweden, based on the same concept as the face-to-face BOA programme. In line with BOA, Joint Academy follows national and international guidelines and best practice for OA treatment. Results from observational studies suggest that this digital treatment is a valuable alternative to the traditional treatment approach and can positively impact patients' function and pain. However, conclusions from such studies commonly suggest that more rigorous testing is necessary to ascertain the benefits of digital treatment delivery for people with OA.

Methods and analysis: A randomised clinical trial will be performed, comparing regular face-to-face care according to BOA with the digital version, Joint Academy. A total of 270 participants with clinically diagnosed knee OA will be recruited at primary care centres and randomised to either standard treatment (BOA) for 3 months, or the experimental group (digital intervention programme). Both groups will receive educational sessions and exercises yet with a difference in programme deliverance. The objective of the trial is to evaluate the effectiveness of the online treatment programme, in comparison with BOA. The two treatment groups will be compared with respect to the number of repetitions of the 30 s chair stand test at 3, 6 and 12 months, using a mixed model repeated measures analysis of variance.

Ethics and dissemination: Ethical approval has been attained from the Regional Board of Ethics in Lund, Sweden (Dnr 2017/719). Results will be published in peer-reviewed journals.

Trial registration number: NCT03328741.

Keywords: adult orthopaedics; knee; telemedicine.

Conflict of interest statement

Competing interests: HN is hired as a part-time consultant for Arthro, the corporation behind JA, and LED is the unemployed CMO of Arthro.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart of the study design. BOA, Better management of patients with OsteoArthritis; HRQoL, health-related quality of life; OA, osteoarthritis; PT, physiotherapist.

References

    1. American Academy of Orthopedic Surgeons. Treatment of Osteoarthritis of the Knee. Evidence-based guideline. 2nd edition, 2013. .
    1. National Institute for Health and Care Excellence - Osteoarthritis: care and management. Clinical guideline.
    1. Better management of patients with OsteoArthritis (BOA).
    1. Zhang W, Nuki G, Moskowitz RW, et al. . OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage 2010;18:476–99. 10.1016/j.joca.2010.01.013
    1. Thorstensson CA, Garellick G, Rystedt H, et al. . Better Management of Patients with Osteoarthritis: Development and Nationwide Implementation of an Evidence-Based Supported Osteoarthritis Self-Management Programme. Musculoskeletal Care 2015;13:67–75. 10.1002/msc.1085
    1. Jönsson T, Ekvall Hansson E, Thorstensson C, et al. . The effect of education and supervised exercise on physical activity, pain, quality of life and self-efficacy - an intervention study with a reference group. Submitted to BMC Musculoskeletal in December 2017, 2017.
    1. Dahlberg LE, Grahn D, Dahlberg JE, et al. . A Web-Based Platform for Patients With Osteoarthritis of the Hip and Knee: A Pilot Study. JMIR Res Protoc 2016;5:e115 10.2196/resprot.5665
    1. Joint Academy.
    1. Nero H, Dahlberg J, Dahlberg LE. A 6-week web-based osteoarthritis treatment program: Observational quasi-experimental study. J Med Internet Res 2017;19:e422 10.2196/jmir.9255
    1. Bossen D, Veenhof C, Van Beek KE, et al. . Effectiveness of a web-based physical activity intervention in patients with knee and/or hip osteoarthritis: randomized controlled trial. J Med Internet Res 2013;15:e257 10.2196/jmir.2662
    1. Garg S, Garg D, Turin TC, et al. . Web-Based Interventions for Chronic Back Pain: A Systematic Review. J Med Internet Res 2016;18:e139 10.2196/jmir.4932
    1. Lynch SM, Stricker CT, Brown JC, et al. . Evaluation of a web-based weight loss intervention in overweight cancer survivors aged 50 years and younger. Obes Sci Pract 2017;3:83–94. 10.1002/osp4.98
    1. Smittenaar P, Erhart-Hledik JC, Kinsella R, et al. . Translating comprehensive conservative care for chronic knee pain into a digital care pathway: 12-week and 6-month outcomes for the hinge health program. JMIR Rehabil Assist Technol 2017;4:e4 10.2196/rehab.7258
    1. Altman R, Asch E, Bloch D, et al. . Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and therapeutic criteria committee of the american rheumatism association. Arthritis Rheum 1986;29:1039–49.
    1. ACR Diagnostic guidelines.
    1. European Medicines Agency - Clinical investigation of medicinal products used in the treatment of osteoarthritis. 2010. .
    1. Wright AA, Cook CE, Baxter GD, et al. . A comparison of 3 methodological approaches to defining major clinically important improvement of 4 performance measures in patients with hip osteoarthritis. J Orthop Sports Phys Ther 2011;41:319–27. 10.2519/jospt.2011.3515
    1. Centers for Disease Control and Prevention - the 30 second chair stand test.
    1. Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs 2005;14:798–804. 10.1111/j.1365-2702.2005.01121.x
    1. Rolfson O, Wissig S, van Maasakkers L, et al. . Defining an International Standard Set of Outcome Measures for Patients With Hip or Knee Osteoarthritis: Consensus of the International Consortium for Health Outcomes Measurement Hip and Knee Osteoarthritis Working Group. Arthritis Care Res 2016;68:1631–9. 10.1002/acr.22868
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x
    1. Perruccio AV, Stefan Lohmander L, Canizares M, et al. . The development of a short measure of physical function for knee OA KOOS-Physical Function Shortform (KOOS-PS) – an OARSI/OMERACT initiative. Osteoarthritis Cartilage 2008;16:542–50. 10.1016/j.joca.2007.12.014
    1. Olsson SJ, Ekblom Ö, Andersson E, et al. . Categorical answer modes provide superior validity to open answers when asking for level of physical activity: A cross-sectional study. Scand J Public Health 2016;44:70–6. 10.1177/1403494815602830
    1. Ingelsrud LH, Granan LP, Terwee CB, et al. . Proportion of patients reporting acceptable symptoms or treatment failure and their associated KOOS values at 6 to 24 months after anterior cruciate ligament reconstruction: A study from the norwegian knee ligament registry. Am J Sports Med 2015;43:1902–7. 10.1177/0363546515584041
    1. Sassi F, QALYs C, comparing Q. and DALY calculations. Health Policy Plan 2006;21:402–8.
    1. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353–65. 10.2165/00019053-199304050-00006

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다