A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol

Pablo Rodríguez-Sánchez-Laulhé, Luis Gabriel Luque-Romero, Jesús Blanquero, Alejandro Suero-Pineda, Ángela Biscarri-Carbonero, Francisco José Barrero-García, Alberto Marcos Heredia-Rizo, Pablo Rodríguez-Sánchez-Laulhé, Luis Gabriel Luque-Romero, Jesús Blanquero, Alejandro Suero-Pineda, Ángela Biscarri-Carbonero, Francisco José Barrero-García, Alberto Marcos Heredia-Rizo

Abstract

Background: Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA)-related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA.

Methods: The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programs, self-management, and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up.

Discussion: This study will evaluate the effectiveness of a tele-rehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient's status and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care.

Trial registration: ClinicalTrials.gov NCT04263974 . Registered on 7 March 2020. Date of last update 15 April 2020. Ethics committee code: PI_RH_2018.

Keywords: E-health; Education; Exercise therapy; Mobile applications; Protocol; Randomized controlled trial; Rheumatoid arthritis; Self-management; Tele-rehabilitation.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram template
Fig. 2
Fig. 2
The CareHand application
Fig. 3
Fig. 3
Standard Protocol Items Recommendation for Interventional Trials (SPIRIT) figure

References

    1. Zamanpoor M. The genetic pathogenesis, diagnosis and therapeutic insight of rheumatoid arthritis. Clin Genet. 2019;95:547–557.
    1. Williams MA, Williamson EM, Heine PJ, Nichols V, Glover MJ, Dritsaki M, et al. Strengthening and stretching for rheumatoid arthritis of the hand (SARAH). A randomised controlled trial and economic evaluation. Health Technol Assess. 2015;19:1–222.
    1. Minichiello E, Semerano L, Boissier MC. Time trends in the incidence, prevalence, and severity of rheumatoid arthritis: a systematic literature review. Joint Bone Spine. 2016;83:625–630.
    1. Sociedad Española de Reumatología. Estudio EPISER 2000. Prevalencia e impacto las enfermedades reumáticas en la población adulta española. . Accessed 2 Apr 2020.
    1. Croia C, Bursi R, Sutera D, Petrelli F, Alunno A, Puxeddu I. One year in review 2019: pathogenesis of rheumatoid arthritis. Clin Exp Rheumatol. 2019;37:347–357.
    1. Horsten NC, Ursum J, Roorda LD, van Schaardenburg D, Dekker J, Hoeksma AF. Prevalence of hand symptoms, impairments and activity limitations in rheumatoid arthritis in relation to disease duration. J Rehabil Med. 2010;42:916–921.
    1. Sharif K, Sharif A, Jumah F, Oskouian R, Tubbs RS. Rheumatoid arthritis in review: clinical, anatomical, cellular and molecular points of view. Clin Anat. 2018;31:216–223.
    1. Roubenoff R. Exercise and inflammatory disease. Arthritis Rheum. 2003;49:263–266.
    1. Rønningen A, Kjeken I. Effect of an intensive hand exercise programme in patients with rheumatoid arthritis. Scand J Occup Ther. 2008;15:173–183.
    1. O’Brien AV, Jones P, Mullis R, Mulherin D, Dziedzic K. Conservative hand therapy treatments in rheumatoid arthritis - a randomized controlled trial. Rheumatology (Oxford) 2006;45:577–583.
    1. Bergstra SA, Murgia A, Te Velde AF, Caljouw SR. A systematic review into the effectiveness of hand exercise therapy in the treatment of rheumatoid arthritis. Clin Rheumatol. 2014;33:1539–1548.
    1. Metsios GS, Kitas GD. Physical activity, exercise and rheumatoid arthritis: effectiveness, mechanisms and implementation. Best Pract Res Clin Rheumatol. 2018;32:669–682.
    1. Zhang W, Anis AH. The economic burden of rheumatoid arthritis: beyond health care costs. Clin Rheumatol. 2011;30(Suppl 1):S25–S32.
    1. Fazal SA, Khan M, Nishi SE, Alam F, Zarin N, Bari MT, et al. A clinical update and global economic burden of rheumatoid arthritis. Endocr Metab Immune Disord Drug Targets. 2018;18:98–109.
    1. Burmester GR, Pope JE. Novel treatment strategies in rheumatoid arthritis. Lancet. 2017;389:2338–2348.
    1. Williams MA, Srikesavan C, Heine PJ, Bruce J, Brosseau L, Hoxey-Thomas N, et al. Exercise for rheumatoid arthritis of the hand. Cochrane Database Syst Rev. 2018;7:CD003832.
    1. Joensuu JT, Huoponen S, Aaltonen KJ, Konttinen YT, Nordström D, Blom M. The cost-effectiveness of biologics for the treatment of rheumatoid arthritis: a systematic review. PLoS One. 2015;10:e0119683.
    1. Hammond A, Prior Y. The effectiveness of home hand exercise programmes in rheumatoid arthritis: a systematic review. Br Med Bull. 2016;119:49–62.
    1. Chaudhari P. The impact of rheumatoid arthritis and biologics on employers and payers. Biotechnol Healthc. 2008;5:37–44.
    1. Lamb SE, Williamson EM, Heine PJ, Adams J, Dosanjh S, Dritsaki M, et al. Exercises to improve function of the rheumatoid hand (SARAH): a randomised controlled trial. Lancet. 2015;385:421–429.
    1. Cole T, Robinson L, Romero L, O’Brien L. Effectiveness of interventions to improve therapy adherence in people with upper limb conditions: a systematic review. J Hand Ther. 2019;32:175–183.
    1. Roddy E, Zhang W, Doherty M, Arden NK, Barlow J, Birrell F, et al. Evidence-based recommendations for the role of exercise in the management of osteoarthritis of the hip or knee--the MOVE consensus. Rheumatology (Oxford) 2005;44:67–73.
    1. Manning VL, Hurley MV, Scott DL, Coker B, Choy E, Bearne LM. Education, self-management, and upper extremity exercise training in people with rheumatoid arthritis: a randomized controlled trial. Arthritis Care Res (Hoboken) 2014;66:217–227.
    1. Hale K, Capra S, Bauer J. A framework to assist health professionals in recommending high-quality apps for supporting chronic disease self-management: illustrative assessment of type 2 diabetes apps. JMIR mHealth uHealth. 2015;3:e87.
    1. Blanquero J, Cortés-Vega MD, García-Frasquet MA, Sánchez-Laulhé PR, de los Bernardos MI ND, Suero-Pineda A. Exercises using a touchscreen tablet application improved functional ability more than an exercise program prescribed on paper in people after surgical carpal tunnel release: a randomised trial. J Physiother. 2019;65:81–87.
    1. Dixon WG, Michaud K. Using technology to support clinical care and research in rheumatoid arthritis. Curr Opin Rheumatol. 2018;30:276–281.
    1. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum. 2002;46:328–346.
    1. Ellegaard K, Von Bülow C, Røpke A, Bartholdy C, Hansen IS, Rifbjerg-Madsen S, et al. Hand exercise for women with rheumatoid arthritis and decreased hand function: an exploratory randomized controlled trial. Arthritis Res Ther. 2019;21:158.
    1. Dritsaki M, Petrou S, Williams M, Lamb SE. An empirical evaluation of the SF-12, SF-6D, EQ-5D and Michigan Hand Outcome Questionnaire in patients with rheumatoid arthritis of the hand. Health Qual Life Outcomes. 2017;15:20.
    1. Kroon FPB, Boersma A, Boonen A, van Beest S, Damman W, van der Heijde D, et al. Performance of the Michigan Hand Outcomes Questionnaire in hand osteoarthritis. Osteoarthr Cartil. 2018;26:1627–1635.
    1. Waljee JF, Chung KC, Kim HM, Burns PB, Burke FD, Wilgis EF, et al. Validity and responsiveness of the Michigan Hand Questionnaire in patients with rheumatoid arthritis: a multicenter, international study. Arthritis Care Res. 2010;621:1569–1577.
    1. Shauver MJ, Chung KC. The minimal clinically important difference of the Michigan hand outcomes questionnaire. J Hand Surg Am. 2009;34:509–514.
    1. Miranda D, Ramírez J, Rueda L, García J, Wolf G, Lugo LH. Validación del “Michigan Hand Outcomes Questionnaire ” para población colombiana. Rev Colomb Reumatol. 2008;15:271–290.
    1. Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999;79:231–252.
    1. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for pain (VAS Pain), Numeric Rating Scale for pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) Arthritis Care Res. 2011;63(Suppl 11):240–252.
    1. Castarlenas E, de la Vega R, Jensen MP, Miró J. Self-report measures of hand pain intensity: current evidence and recommendations. Hand Clin. 2016;32:11–19.
    1. Wolfe F, Michaud K. Assessment of pain in rheumatoid arthritis: minimal clinically significant difference, predictors, and the effect of anti-tumor necrosis factor therapy. J Rheumatol. 2007;34:1674–1683.
    1. Higgins SC, Adams J, Hughes R. Measuring hand grip strength in rheumatoid arthritis. Rheumatol Int. 2018;38:707–714.
    1. Irwin CB, Sesto ME. Reliability and validity of the multiaxis profile dynamometer with younger and older participants. J Hand Ther. 2010;23:281–289.
    1. Kennedy D, Jerosch-Herold C, Hickson M. The reliability of one vs. three trials of pain-free grip strength in subjects with rheumatoid arthritis. J Hand Ther. 2010;23:384–391.
    1. Bohannon RW. Minimal clinically important difference for grip strength : a systematic review. J Phys Ther Sci. 2019;31:75–78.
    1. MacDermid JC, Kramer JF, Woodbury MG, Mcfarlane RM, Roth JH. Interrater reliability of pinch and grip strength measurements in patients with cumulative trauma disorders. J Hand Ther. 1994;7:10–14.
    1. Salaffi F, Di Carlo M, Carotti M, Farah S. Validity and interpretability of the QuickDASH in the assessment of hand disability in rheumatoid arthritis. Rheumatol Int. 2019;39:923–932.
    1. Smith-Forbes EV, Howell DM, Willoughby J, Pitts DG, Uhl TL. Specificity of the minimal clinically important difference of the quick Disabilities of the Arm Shoulder and Hand (QDASH) for distal upper extremity conditions. J Hand Ther. 2016;29:81–88.
    1. Carroll MB. The QuickDASH in the assessment of rheumatoid arthritis disease activity. Osteol Rheumatol Open J. 2016;1:23–29.
    1. Hammond A, Prior Y, Tyson S. Linguistic validation, validity and reliability of the British English versions of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and QuickDASH in people with rheumatoid arthritis. BMC Musculoskelet Disord. 2018;19:118.
    1. Gummesson C, Ward MM, Atroshi I. The shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH. BMC Musculoskelet Disord. 2006;7:44.
    1. Hervás MT, Navarro Collado MJ, Peiró S, Rodrigo Pérez JL, López Matéu P, Martínez TI. Spanish version of the DASH questionnaire. Cross-cultural adaptation, reliability, validity and responsiveness. Med Clin. 2006;127:441–447.
    1. London DA, Stepan JG, Calfee RP. Determining the Michigan Hand Outcomes Questionnaire minimal clinically important difference by means of three methods. Plast Reconstr Surg. 2014;133:616–625.
    1. Van Riel P, Alten R, Combe B, Abdulganieva D, Bousquet P, Courtenay M, et al. Improving inflammatory arthritis management through tighter monitoring of patients and the use of innovative electronic tools. RMD Open. 2016;2:1–9.
    1. de Thurah A, Stengaard-Pedersen K, Axelsen M, Fredberd U, Schougaard LMV, Hjollund NHI, et al. Tele-health follow up strategy for tight control of disease activity in rheumatoid arthritis: results of a randomized controlled trial. Arthritis Care Res (Hoboken) 2018;70:353–360.
    1. Seppen BF, L'ami MJ, Duarte Dos Santos Rico S, Ter Wee MM, Turkstra F, Roorda LD, et al. A smartphone app for self-monitoring of rheumatoid arthritis disease activity to assist patient-initiated care: protocol for a randomized controlled trial. JMIR Res Protoc. 2020;9:e15105.
    1. Kloppenburg M. Hand osteoarthritis--an increasing need for treatment and rehabilitation. Curr Opin Rheumatol. 2007;19:179–183.
    1. Porcheret M, Jordan K, Jinks C, Croft P, Primary Care Rheumatology Society Primary care treatment of knee pain--a survey in older adults. Rheumatology (Oxford) 2007;46:1694–1700.
    1. Hill S, Dziedzic KS, Ong BN. The functional and psychological impact of hand osteoarthritis. Chronic Illn. 2010;6:101–110.
    1. Dziedzic K, Thomas E, Hill S, Wilkie R, Peat G, Croft PR. The impact of musculoskeletal hand problems in older adults: findings from the North Staffordshire Osteoarthritis Project (NorStOP) Rheumatology (Oxford) 2007;46:963–967.
    1. Wessel J. The effectiveness of hand exercises for persons with rheumatoid arthritis: a systematic review. J Hand Ther. 2004;17:174–180.
    1. Booth J, Moseley GL, Schiltenwolf M, Cashin A, Davies M, Hübscher M. Exercise for chronic musculoskeletal pain: a biopsychosocial approach. Musculoskeletal Care. 2017;15:413–421.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner