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Clinical Trial

MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique

NCT: NCT03304028 · TERMINATED

NCT IDNCT03304028
StatusTERMINATED
Start Date2017-10-20
Completion2020-06-18
SponsorInstitut National de la Santé Et de la Recherche Médicale, France (OTHER_GOV)
First posted
Last updated

Brief 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.

Frequently Asked Questions

What is MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique?

MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique is a clinical trial registered under NCT03304028. Current status: TERMINATED.

What is the status of NCT03304028?

The current status of NCT03304028 (MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique) is: TERMINATED.

When did MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique start?

MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique started on 2017-10-20.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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