Muco Smartphone Exacerbation

Cystic Fibrosis Clinical Trial

— MUSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122289
• Other study ID #: 9172
• Status: Completed
• Phase: Phase 0
• First received: April 22, 2014
• Last updated: April 11, 2016
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Application of Smartphone
Weekly questionnaire on smartphone

Other:
• No application Smartphone
No weekly questionnaire on smartphone

Locations

Country	Name	City	State
France	CRCM	Giens
France	CRCM	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of exacerbation		up to 6 months	No
Secondary	Satisfactory status and compliance		up to 6 months	No