Effect of a mHealth exercise intervention compared with supervised exercise therapy in osteoarthritis management: protocol of the DigiOA trial

INTRODUCTION: Soaring prevalence of hip and knee osteoarthritis (OA) inflicts high costs on the healthcare system. A further rise in the OA incidence is expected, generating increased demand of care potentially challenging accessibility and threatening to overwhelm the healthcare system. Innovative solutions that may improve accessibility to recommended OA care for patients in primary care and maintain healthcare sustainability are warranted. Digitalising home exercise therapy may be one such solution. The primary aim of this study is to evaluate the effectiveness of a mobile health app providing digitalised home exercises, compared with supervised exercise therapy in patients with OA. Second, we will evaluate the cost-efficiency of the intervention and explore potential differences in outcome and adherence to exercises in the experimental treatment group. METHODS AND ANALYSIS: A two-armed non-inferiority randomised controlled trial will be conducted. In total, 156 patients with hip and/or knee OA will be recruited from physiotherapy clinics in primary care in Norway. Following patient education, patients will be randomised to either 6 weeks of standard treatment (2 weekly sessions of supervised exercise therapy) or experimental treatment (home exercises via the Virtual Training (VT) app). Primary outcome is the proportion of Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responders at 6 weeks. Secondary outcomes include physical performance, patient-reported outcomes related to pain, fatigue, disease activity, physical function, mental health, health related quality of life, self-efficacy, utilisation of healthcare services and medication, digital competence and use of apps. ETHICS AND DISSEMINATION: Patients will sign an informed consent form before participating in the trial. Approval has been granted by the Regional Ethics Committee (201105) and Data Protection Officer at Diakonhjemmet Hospital (00221). Patient research partners will contribute in all parts of the study. TRIAL REGISTRATION NUMBER: NCT04767854.