RIabilitazione di Pazienti COvid e Loro Monitoraggio IN Casa Con la pIattaforma ARc-IntEllicare - (RICOMINCIARE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Device-related adverse events
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A) Post-Covid-19 people: at home post-COVID-19 volunteers 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 (e.g., Parkinson's Disease) or respiratory syndrome (e.g., COPD, pulmonary fibrosis)
- •All subjects have to meet the following criteria:
- •Men and women> 18 years,
- •Moderate dyspnea in activities of daily living (ADL) (Barthel's dyspnea score ≤55) or walking difficulties or upper limb disabilities due to central or peripheral neurological lesions that, eventually, emerged following Covid-19 or Walking Handicap Scale (Perry and Garrett '95) ≤ 5
- •Informed consent signed
排除标准
- •Fever (TC ≥ 37 ° C)
- •Cough, cold, sore throat, diarrhoea or pneumonia signs and diagnosis
- •People with moderate to severe cognitive impairment (MoCA <20)
- •Formal rehabilitation performed in the last month
- •Pre-existing disability related to neurodegenerative disorders or severe stroke (TACI); epilepsy, seizures and a history of severe dizziness and falls.
- •Severe non-stabilized comorbidities: oncological diseases in the active phase; NYHA stage IV congestive heart failure; severe respiratory failure requiring cough and support for breathing; life expectancy of less than 6 months.
- •Moderate or severe dependence in activities of daily living for any medical reason (such as the participant's inability to notice or suspect to comply with the protocol procedure) or other reason the investigator believes the participant is ineligible to study (Rankin mod. ≤
- •Women of childbearing potential who are not using suitable valid methods of contraception
结局指标
主要结局
Device-related adverse events
时间窗: Through study completion (8 months)
Number and type of device-related adverse events reported
Attrition rate
时间窗: Through study completion (8 months)
% of patients who discontinue the study before the 30-day intervention period
Adherence Rate
时间窗: Daily evaluation performed on each patient using ARC during 30-day study period
Adherence to home rehabilitation program with ARC intellicare. The adherence rate is calculated as a percentage of the number of sessions performed at home by the patient compared to the maximum number of rehabilitation sessions prescribed with ARC.
次要结局
- Patient Satisfaction(Pre (baseline) and post-intervention (30 days after))
- Resource consumption(Through study completion (8 months))
- System Usability Scale (SUS)(Pre (baseline) and post-intervention (30 days after))