Muco Smartphone Exacerbation

Study Overview
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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.

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.

Official Title
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Interest of the New Technologies to Detect précocément a Respiratory Exacerbation at Patients Reached by Cystic Fibrosis.

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: Application of Smartphone
* Other: No application Smartphone


Participation Criteria
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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 Exclusion criteria: Patients who are include in an interventional study Patient who is not able to read French language Patients with psychological disorder

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Application of Smartphone<br>Weekly questionnaire on Smartphone | Device: Application of Smartphone<br>* Weekly questionnaire on smartphone<br>|
| Placebo Comparator: No application Smartphone<br>No Weekly questionnaire on Smartphone | Other: No application Smartphone<br>* No weekly questionnaire on smartphone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of exacerbation |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfactory status and compliance |  | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exacerbation, QoL