At Home REhabilitation and Monitoring of People in poST-covid Condition Through ARc-inTellicare Platform (RESTART/RICOMINCIARE) — RICOMINCIARE  

Parkinson Disease Clinical Trial

Official title: RIabilitazione di Pazienti COvid e Loro Monitoraggio IN Casa Con la pIattaforma ARc-IntEllicare - (RICOMINCIARE)

Status Completed

Clinical Trial Summary

The RESTART/RICOMINCIARE study is a pilot single-center, not controlled prospective, pre-post intervention study aimed at verifying feasibility and safety of a device-supported home rehabilitation for people suffering from mild to moderate disabilities due to respiratory or neurological conditions, related to Covid-19 or frailty condition (i.e. Parkinson Disease).

Clinical Trial Description

The RICOMINCIARE project aims at contributing to the Covid-19 pandemic emergency by promoting the health and recovery of people recovering from Covid-19 and supporting frail people, providing an innovative telemedicine solution for the continuity of rehabilitation, able to promote and monitor remote physical rehabilitation activities in the elderly in isolation and remission from Covid-19, while containing the risk of spreading the infection. Between the people suffering from Covid-19, 80% show symptoms and 32% need hospitalization. It is estimated that the most severe cases (about 20%) have functional sequelae that persist for more than 6 months after diagnosis. In consideration of the absence of a vaccine or specific therapy, social distancing represents the main tool for limiting the infection. The use of tele-medicine is recommended and useful for everyone to ensure continuity of care in terms of monitoring, prevention and treatment

Primary objectives: to test the feasibility of integrating the ARC-Intellicare solution into the care pathway for Covid-19 survivors or frail people in terms of:

(i) adherence to the home rehabilitation program (ii) safety of rehabilitation therapy Secondary objectives: to investigate the (iiI) usability and acceptability of the intervention; (iv) the process and resources required for the new care pathway. The rehabilitation will take place according to the Good Clinical Practice (GCP) and the available guidelines regarding rehabilitation protocols and clinical and functional assessment for chronic respiratory syndromes, Post-Covid-19 conditions and neurological diseases related disabilities. Therefore, participants will undergo pre-post intervention monitoring of the clinical and functional status in terms of independence in the activities of daily life, endurance, fatigue, emotional state, quality of life following GCP.

Study design. The RICOMINCIARE study will be a pilot single-center, not controlled prospective, pre-post intervention study aimed at verifying feasibility and safety of a device supported home rehabilitation for people suffering from mild to moderate disabilities due to respiratory or neurological conditions possibly related to Covid-19.

Population. 5-10 people will be enrolled in the study between subjects who consecutively refers themselves to the study participating clinical center (Università Politecnica delle Marche, Dipartimento di Medicina Sperimentale e Clinica, Ancona) for rehabilitation management of a post-COVID-19 condition or in frailty.

A) Post-Covid-19 people: at home post-COVID-19 volunteers (discharged from hospital at home or treated at home) who have recovered from SARS-COV-2 infection (healing = two 24-hour consecutive oropharyngeal tampons negative for SARS-COV-2) from at least 15 days B) Frail people who score 9-12 on the Edmonton Frail Scale (EFS) due to neurological lesions of the motor system (i.e. Parkinson's Disease) or respiratory syndrome (COPD, pulmonary fibrosis...). Individuals should have no signs of ongoing pneumonia.

Intervention. The two-month study involves the recruitment of at least 20 patients who will use ARC-Intellicare at home, to perform usability tests and a collection of useful data in order to optimize the system.

Subsequently, the same patients will each receive an ARC-Intellicare unit for home use, to be used independently for the next 30 days.

45 minutes 5 days / week for 4 weeks of personalized training will be carried out by the enrolled subjects: 4 weekly sessions will be unsupervised, while one will be supervised remotely by a therapist in telepresence, thanks to the integrated audio-video channel.

Primary Endpoints. The primary endpoints are an adherence rate of 80% (+/- 5%) and a rate of participants' attrition (expected dropouts) of no more than 15%. The reasons for dropout or interruptions and side effects (number and types of adverse events related to the use of ARC) will also be monitored

Secondary endpoints. Secondary endpoints are a System Usability Scale (SUS) score administered to participants and informal health care workers or health care workers> 70 (i.e., the solution has a good level of usability) and a patient satisfaction of at least 80% on average on visual analog scale

Assessment timing. The entry variables and the clinical-functional data, according to the GCP, are acquired at enrolment / baseline assessment (T0) or within 7 days from the start of home intervention and at the end of the 30 days of intervention (T1), when monitoring of the primary and secondary outcome measures on adherence, acceptability and safety will be completed. ;

Related Conditions & MeSH terms

• COVID-19
• Parkinson Disease
• Post-COVID19

• NCT number: NCT05074771
• Study type: Interventional
• Source: Camlin Ltd
• Status: Completed
• Phase: N/A
• Start date: March 26, 2021
• Completion date: March 30, 2022