Adopting a multidisciplinary telemedicine intervention for fall prevention in Parkinson’s disease. Protocol for a longitudinal, randomized clinical trial
Esther Cubo, Álvaro García‐Bustillo, Álvar Arnaiz‐González, José Miguel Ramírez‐Sanz, José Luis Garrido‐Labrador, Florita Valiñas, Marta Allende, Jerónimo J. González‐Bernal, Josefa González‐Santos, José-Francisco Díez-Pastor, Maha Jahouh, Jana Arribas, José M. Trejo
Abstract
BACKGROUND: Approximately 40-70% of people with Parkinson's disease (PD) fall each year, causing decreased activity levels and quality of life. Current fall-prevention strategies include the use of pharmacological and non-pharmacological therapies. To increase the accessibility of this vulnerable population, we developed a multidisciplinary telemedicine program using an Information and Communication Technology (ICT) platform. We hypothesized that the risk for falling in PD would decrease among participants receiving a multidisciplinary telemedicine intervention program added to standard office-based neurological care. OBJECTIVE: To determine the feasibility and cost-effectiveness of a multidisciplinary telemedicine intervention to decrease the incidence of falls in patients with PD. METHODS: Ongoing, longitudinal, randomized, single-blinded, case-control, clinical trial. We will include 76 non-demented patients with idiopathic PD with a high risk of falling and limited access to multidisciplinary care. The intervention group (n = 38) will receive multidisciplinary remote care in addition to standard medical care, and the control group (n = 38) standard medical care only. Nutrition, sarcopenia and frailty status, motor, non-motor symptoms, health-related quality of life, caregiver burden, falls, balance and gait disturbances, direct and non-medical costs will be assessed using validated rating scales. RESULTS: This study will provide a cost-effectiveness assessment of multidisciplinary telemedicine intervention for fall reduction in PD, in addition to standard neurological medical care. CONCLUSION: In this challenging initiative, we will determine whether a multidisciplinary telemedicine intervention program can reduce falls, as an alternative intervention option for PD patients with restricted access to multidisciplinary care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04694443.