Contribution of a Multimodal Digital Platform in the Management and Follow-up of Patients With Amyotrophic Lateral Sclerosis Treated With Non-invasive Ventilation: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Difference in change in functional abilities between the experimental and control groups over 6 months of follow-up.
研究概览
简要总结
The median survival of patients with amyotrophic lateral sclerosis (ALS) is 3 to 5 years and mortality is mainly related to respiratory failure. Non-invasive ventilation (NIV) and multidisciplinary management improve the quality of life and survival of patients. However, patients have mobility difficulties related to the progressive worsening of functional disabilities. The research team hypothesize that the use of a multimodal digital platform, including in particular telemonitoring of NIV and teleconsultation, will slow down the evolution of the disabilities of patients with ALS and improve their quality of life.
详细描述
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with a median life expectancy of 3 to 5 years. Respiratory failure due to alveolar hypoventilation is the main cause of mortality and respiratory impairment leads to a significant deterioration in quality of life.
Non-invasive ventilation (NIV) improves patient quality of life, improves gas exchange and improves patient survival. NIV should be initiated early, based on symptomatology and lung function, and monitored closely to adjust device parameters. NIV is a complex intervention that must be individualized for each patient.
In addition, multidisciplinary management involving different healthcare professionals, keeping the patient and caregivers at the center of the network, also allows for an improvement in the quality of life and survival of these patients.
However, patients with ALS have difficulty moving around and access to care becomes more complicated as the disease progresses. This phenomenon was increased during the COVID- 19 pandemic with a more rapid functional decline.
The development of new technologies should make it possible to rethink patient management, in particular through remote monitoring of NIV devices, teleconsultation, administration of questionnaires and better interprofessional organization. Several studies have confirmed the feasibility and acceptance of telemedicine solutions in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 30 and 85 years old
- •Diagnosis of ALS
- •Indication and acceptance of non-invasive ventilation
- •Patient equipped with suitable equipment (tablet, computer, telephone, etc.) with an internet connection at home
- •Patient able to read and understand the procedure, and able to express consent for the study protocol
排除标准
- •Treatment with non-invasive ventilation in the previous three months
- •Refusal/inability to use a smart phone or digital device
- •Patient currently participating or having participated in the month preceding inclusion in another clinical interventional research that could impact the study, this impact is left to the discretion of the investigator.
- •Subject under guardianship or curators
- •Subject not affiliated to a social security scheme, or not a beneficiary of such a scheme.
- •Subject deprived of liberty by judicial or administrative decision
- •Pregnant, parturient, breastfeeding women
- •Refusal to give consent
研究组 & 干预措施
Experimental
A group of 29 patients with ALS will be formed to the multimodal digital platform associated with Non Invasive Ventilation (NIV) and usual management
Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.
干预措施: Telerehabilitation solution (m-Rehab) (Other)
Experimental
A group of 29 patients with ALS will be formed to the multimodal digital platform associated with Non Invasive Ventilation (NIV) and usual management
Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.
干预措施: Usual management including NIV. (Other)
Control Comparator
A group of 29 patients with ALS will be formed : control group following usual management including NIV.
Patients will be treated with NIV equipment from the manufacturer LOWENSTEIN and will benefit from the usual follow-up carried out at the reference center of Montpellier University Hospital.
干预措施: Usual management including NIV. (Other)
结局指标
主要结局
Difference in change in functional abilities between the experimental and control groups over 6 months of follow-up.
时间窗: Between baseline and 6 months
Difference in variation of the functional capabilities assessed by the Amyotrophic lateral sclerosis functional rating scale (ALSFRS) score at Baseline (D0) and 6 months between the experimental group and the control group. A scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality
次要结局
- Evaluation of the NIV parameters between the 2 groups at 3 months(At 3 months)
- Evaluation of the quality and tolerance of NIV between the 2 groups at 3 months(At 3 months)
- Evaluation at 3 months in the experimental group of the Satisfaction of professionals with the digital solution(At 3 months)
- Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal capnography(At 6 months)
- Evaluation at 6 months in the experimental group of the Patient satisfaction with the digital solution(At 6 months)
- Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (BMI)(Between Baseline and 3 months)
- Evaluation of the quality and tolerance of NIV between the 2 groups at 6 months(At 6 months)
- Evaluation of the effectiveness of NIV between the 2 groups at 6 months assessed by nocturnal oximetry(At 6 months)
- Evaluation of the NIV parameters between the 2 groups at 6 months(At 6 months)
- Evaluation of survival between the 2 groups at 3 months(At 3 months)
- Evaluation at 6 months in the experimental group of the Satisfaction of professionals with the digital solution(At 6 months)
- Evaluation at 3 months in the experimental group of the Patient satisfaction with the digital solution(At 3 months)
- Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal oximetry(At 3 months)
- Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between 3 months and 6 months).(Between 3 months and 6 months)
- Evolution of dyspnea between the 2 groups between baseline and 6 months(Between Baseline and 6 months)
- Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 6 months(Between Baseline and 6 months)
- Evolution of Quality of life between the 2 groups between baseline and 3 months(Between Baseline and 3 months)
- Evolution of Patient satisfaction between the 2 groups between baseline and 3 months(Between Baseline and 3 months)
- Evolution of Caregivers satisfaction between the 2 groups between baseline and 6 months(Between Baseline and 6 months)
- Difference in change in functional abilities between the experimental and control groups during 3 months of follow-up (Between Baseline and 3 months).(Between Baseline and 3 months)
- Evolution of dyspnea between the 2 groups between baseline and 3 months(Between Baseline and 3 months)
- Evolution of evaluation of Anxiety and depression between the 2 groups between baseline and 3 months(Between Baseline and 3 months)
- Evolution of Caregivers satisfaction between the 2 groups between baseline and 3 months(Between Baseline and 3 months)
- Evolution of Anthropometric criteria between the 2 groups between baseline and 3 months (Weight measurements)(Between Baseline and 3 months)
- Evolution of Quality of life between the 2 groups between baseline and 6 months(Between Baseline and 6 months)
- Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (BMI)(Between Baseline and 6 months)
- Medico-economic evaluation: incremental cost-utility ratio(6 months)
- Evaluation at 3 months in the experimental group of the caregiver satisfaction with the digital solution(At 3 months)
- Evolution of Patient satisfaction between the 2 groups between baseline and 6 months(Between Baseline and 6 months)
- Evolution of Anthropometric criteria between the 2 groups between baseline and 6 months (weight measurements)(Between Baseline and 6 months)
- Evaluation of the effectiveness of NIV between the 2 groups at 3 months assessed by nocturnal capnography(At 3 months)
- Evaluation of time to first hospitalization between the 2 groups at 3 months(At 3 months)
- Evaluation of survival between the 2 groups at 6 months(At 6 months)
- Evaluation of time to first hospitalization between the 2 groups at 6 months(At 6 months)
- Evaluation at 6 months in the experimental group of the caregiver satisfaction with the digital solution(At 6 months)