System Integrated Digital Empowerment and Rehabilitation to promote patient Activation and well-Being (SIDERA^B): Protocol for a Randomized Crossover Trial on Effectiveness and Implementation

CONTEXT the current increasing demand for rehabilitation among people with Non-Communicable Diseases (NCDs) requires the identification of home-based digital solutions alternative to conventional in-clinic interventions. OBJECTIVE this protocol proposes to test the effectiveness of an individualized telerehabilitation platform (SIDERA^B), with respect to the traditional face-to-face rehabilitation, in ensuring the continuity of care in patients with NCDs. DESIGN, SETTING, AND SUBJECTS this randomized, single-blind, controlled two-period crossover trial will involve about 150 outpatients with NCDs (N=40 with Chronic Heart Failure – CHF, N=60 with Chronic Obstructive Pulmonary Disease – COPD, and N=50 with Parkinson’s Disease – PD) from the rehabilitation units of IRCCS Fondazione Don Carlo Gnocchi of Milan. Each participant will experience, consequently, two different types of interventions: rehabilitation with the SIDERA^B system (SIDERA^B – S), which allow for both tele-rehabilitation activities and tele-monitoring of vital parameters, and rehabilitation as usual (Usual Care – U) including a manual of rehabilitative exercises and self-monitoring of vital parameters. INTERVENTIONS subjects will be randomly assigned to one of the two specified sequences of interventions: U/S/U (the USU group), and S/U (the SU group). Both groups will be assessed at the baseline (T1), after the first intervention (T2), and after the second intervention (T3), with a follow-up evaluation (T4) scheduled only for the USU group. MAIN OUTCOME MEASURES a multifaceted evaluation including quality of life and clinical/functional measures will be conducted at each time-point of assessment. The primary outcome measures will be 1) change in activation of patients measured by the Patient Activation Measure scale, and 2) change in subject’s level of activity and participation measured by the WHO Disability Assessment Schedule 2.0. CONCLUSION SIDERA^B could represent a promising innovative digital solution able to support the ongoing migration of rehabilitation care from the clinic to the patient’s home, for the optimal long-term management of NCDs. Trial registration The SIDERA^B trial was registered in the clinicaltrials.gov database (identifier NCT04041193 ) on August 1, 2019.