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MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Summary
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.
Official title: Use of Home-based Connected Devices to Early Detect and Treat Pulmonary Exacerbations: Feasibility and Clinical Validity in CF Patients
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2017-10-20
Completion Date
2020-06-18
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
Connected Devices for 3 months
Inclusion will be proposed at a follow-up visit by the child's or adult's referring doctor. A written informed consent form will be obtained. Quality of Life and Anxiety-Depression will be collected. Then, each included patient will be equipped with CDs-spirometer, oxymeter, scale and watch during 3 months for base-line.
Educationnal Intervention
After a first statistical analysis and interpretation (5 months), alert parameters for each patient are then fixed. An educational visit will be scheduled with patients and a personnalized action plan will be defined..
Connected Devices for 12 months
Each included patient will be re-equipped with CDs-spirometer, oxymeter, scale and watch during 12 months. If alerts occur, patients will be informed by email or SMS, with data transmission to the medical team who will not interfere. Patients should apply the shared action plan they learned. Quality of Life and Anxiety-Depression will be collected.
Interviews
At the end, semi-structured interviews will be completed to explore confidence on the CDs, impact on the doctor-patient relationship, change in the workload of medical team…etc.
Refusal Questionnaires
Clinic staff will email all patients or parents (pediatric settings) to introduce the study. A qualitative interview with 10 patients who declined to participate in the study will be conducted to identify the reason of refusal
Locations (7)
CF adults center - Hopital Albert Calmette
Lille, France
CF adults center - Institut du Thorax
Nantes, France
CF pediatrics center - Hopital Mère-Enfant
Nantes, France
CF pediatrics center - Hopital Robert Debré
Paris, France
CF adults and pediatrics center - American Memorial Hospital
Reims, France
CF adults and pediatrics center- Perharidy
Roscoff, France
CF pediatrics center - Hopital André Mignot
Versailles, France