Muco Smartphone Exacerbation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Application of Smartphone

Weekly questionnaire on Smartphone

Group Type EXPERIMENTAL

Application of Smartphone

Intervention Type DEVICE

Weekly questionnaire on smartphone

No application Smartphone

No Weekly questionnaire on Smartphone

Group Type PLACEBO_COMPARATOR

No application Smartphone

Intervention Type OTHER

No weekly questionnaire on smartphone

Interventions

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Application of Smartphone

Weekly questionnaire on smartphone

Intervention Type DEVICE

No application Smartphone

No weekly questionnaire on smartphone

Intervention Type OTHER

Eligibility Criteria

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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