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Terminated
NCT03304028
MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique
Conditions: Cystic Fibrosis
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Location: CF adults center - Hopital Albert Calmette Lille
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT03304028). StuddyBuddy aggregates publicly available trial information.