Use of Home-based Connected Devices to Early Detect and Treat Pulmonary Exacerbations: Feasibility and Clinical Validity in CF Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 14
- 主要终点
- Exacerbations (ExR) concordance
研究概览
简要总结
Early detection of pulmonary exacerbations (PEx) in Cystic Fibrosis (CF) patients is important to quickly trigger treatment and reduce respiratory damage. The investigators hypothesize that using home-based connected devices (CDs) in educated patients applying Cumulative sum charts (CUSUM) to monitor physiological parameters (PP) and patients' perception reported (PRP), will allow early detection of PEx.
Objective: to study clinical validity of using CDs and evaluate adherence and satisfaction in CF patients and teams
Design: 3 phase multicenter study in 36 CF patients aged >=12 years. Phase 1, patients are equipped during 3 months with CDs. PP and PRP to estimate CUSUM parameters are collected. In phase 2, patient's personalized educational plan to manage alerts is built. In phase 3, PP and PRP are collected during 12 months. Clinical validity, change in patients clinical data, quality of Life/Anxiety-Depression/Satisfaction, patients and teams' acceptance and adherence are assessed.
详细描述
BACKGROUND
Pulmonary exacerbations (PEx) are the major cause of lung function decline in Cystic Fibrosis (CF) patients leading to respiratory failure. Identifying warning signs of PEx is a priority to trigger early treatment and reduce respiratory damage. Some authors tried to define scores based on symptoms to standardize treatment. However, lack of consensus led the Euro-Care-CF-Working-Group to recommend the use of medical antibiotic treatment decision (or treatment modification) associated with PEx-like symptoms as best definition of PEx for clinical trials.
A DELPHI study identified 10 signs frequently perceived by patients and 10 most often cited indicators by caregivers. Two studies have shown that a combination of physiological parameters (PP) and patient reported perceptions (PRP) such as weight loss, decreased spirometry , increased cough or increased sputum production reported daily, help diagnose PEx episodes and trigger early treatment. Clinical observations show that changes in PP and PRP related to PEx differ according to age and degree of lung function impairment. Currently, patients with CF do not routinely monitor their lung function at home, nor do they objectively track PP or PRP. Consequently, CF PEx can be diagnosed late when symptoms progress, in which they seek medical care. Thus, development of an effective approach that helps to monitor daily indicators of PEx to early identification and treatment is important.
- Home monitoring of PEx symptoms Several studies have been conducted with daily monitoring of PEx symptoms. Most of these studies monitored one or two respiratory parameters with data transmission to the medical staff who decide what course of action to take. In addition, these studies used for each parameter the same alert limit for all patients, as it is known that patients with CF have different thresholds of these indicators,some may present more frequently than others.
- CUSUM to monitor indicators of pulmonary exacerbation The use of statistical process control (SPC) shows promise for monitoring indicators of CF PEx and rapidly detecting unwanted changes in these indicators. SPC uses rigorous time-series analysis methods, with results reported as a graph of changes in indicators over time[9]. Moreover, SPC can help to determine whether these changes are real (related to a causative factor) or merely a manifestation of natural variability. Among SPC, cumulative sum (CUSUM) chart has been found effective for measuring and monitoring healthcare outcome. It detects changes rapidly, and can identify small shifts. Connected devices software programming integrating CUSUM alert limits can help to determine whether the changes in PP and PRT are due to real PEx episode.
STUDY HYPOTHESIS The investigators hypothesize that using home-based CDs applying CUSUM with patient's personalized alert limits to monitor physiological data and PRP combined with patient education allows early detection of PEx. Studying alerts can help clinicians to develop a patient's personalized educational plan allowing patients better management of PEx including ability to make informed choices. This study aims to assess clinical validity of using different CDs, acceptance and adherence of patients of data collection of physiological data and PRPs, and acceptance by the clinical teams of this process of care. It will lead a larger trial aiming to evaluate efficacy of this process of care on patient's clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 years and over
- •Cystic fibrosis confirmed by sweat test or genetic
- •Able to understand and respect the protocol and its requirements
- •Who signed the consent prior to any other procedure protocolFollowed in the same CF center during the study
- •In clinically stable condition - no pulmonary exacerbation requiring intravenous antibiotics - in the previous 4 weeks)
- •Prescribed at least one pulmonary medication (eg, inhaled mucolytic, inhaled or oral antibiotic therapy, hypertonic saline)
- •Not undergone solid organ transplants
- •With smartphone, computer or tablet connected to wifi access
排除标准
- •Patient undergoing solid organ transplant
- •Pregnancy or planned pregnancy during the period of the study
- •Patient on exclusion period because of other clinical research esearch
- •Patients who don't use connected devices during the 3 first months will be excluded from the study.
结局指标
主要结局
Exacerbations (ExR) concordance
时间窗: 2 Years
Assesses agreement between the ExR episodes detected by the connected objects and the ExR episodes detected by the start date of the antibiotic treatment noted in the patient's medical record
次要结局
- Medical data : FEV1(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Hospital Anxiety and Depression scale (HADS)(Inclusion ; month 3 ; month 10 ; month 22)
- Cystic Fibrosis Questionnaire-Revised (CFQ-R)(Inclusion ; month 3 ; month 10 ; month 22)
- Patients and professionals interviews(2 Years)
- Physiological parameters with connected devices (PP) : FEV1(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Physiological parameters with connected devices (PP) : Oxygen saturation(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Medical data: Weight(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Medical data: Height(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Perceptions identified by patients (PRP)(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Medical data: Heart rate(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Medical data: Oxygen saturation(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Physiological parameters with connected devices (PP) : Weight(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Traitements Duration(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Physiological parameters with connected devices (PP) : Heart rate(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Physiological parameters with connected devices (PP) : Duration of sleep(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Traitements Number(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Exacerbations Number(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Exacerbations Timing(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Physiological parameters with connected devices (PP) : Physical activity(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)
- Respiratory symptoms(Inclusion ; month 3 ; month 10 ; month 13 ; month 16 ; month 19 ; month 22)