Muco Smartphone Exacerbation
Information source: University Hospital, Montpellier
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: Application of Smartphone (Device)
Phase: Phase 0
Status: Recruiting
Sponsored by: University Hospital, Montpellier Official(s) and/or principal investigator(s): Raphael CHIRON, Principal Investigator, Affiliation: University Hospital, Montpellier
Overall contact: nicolas MOLINARI, Email: nicolas.molinari@inserm.fr
Summary
Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity.
Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship
between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments
present health costs burden leading to important physical psychological and social impact.
Preventing exacerbation and early detection of these exacerbations may decrease intensity
and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased
health cost.
Patients actually follow in CRCM track exacerbations when visits out patient clinic and
during phone call. If patients did not call or did not present regularly to out patient
clinic, exacerbation detection came later and so increasde the burden and therapeutic
pressure.
The objective of our study is to identify earlier the potential exacerbations and so
decreased the health costs and increased the patient's QoL. Forthis purpose we propose to
use modern technologiessuch as smartphone in order to create alert when patients report
weekly health satatus. We will compra patients randomize in control group with standart
follow-up to patients randomize in the smartphone group. Moreover we will study the
compliance and satisfactory degree of the use of this device in the interventional arm.
Clinical Details
Official title: Interest of the New Technologies to Detect précocément a Respiratory Exacerbation at Patients Reached by Cystic Fibrosis.
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Frequency of exacerbation
Secondary outcome: Satisfactory status and compliance
Detailed description:
Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity.
Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship
between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments
present health costs burden leading to important physical psychological and social impact.
Preventing exacerbation and early detection of these exacerbations may decrease intensity
and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased
health cost.
Eligibility
Minimum age: 14 Years.
Maximum age: 25 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- CF diagnosis
- Patient able to receive phone call
- Patient who use regulary a smartphone
- age from 14 to 25
- Patients with at least 2 exacerbations before the entry.
- Stable patient at V1
Exclusion criteria:
- Patients who are include in an interventional study
- Patient who is not able to read French language
- Patients with psychological disorder
Locations and Contacts
nicolas MOLINARI, Email: nicolas.molinari@inserm.fr
CRCM, Giens, France; Recruiting Laurent MELY, Email: laurent.mely@chu-lyon.fr
CRCM, Montpellier, France; Recruiting Raphael CHIRON, Email: r-chiron@chu-montpellier.fr
Additional Information
Starting date: April 2014
Last updated: November 14, 2014
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