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OpenTrials
Completed

NCT Number: NCT02122289

Muco Smartphone Exacerbation

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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Key information

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

CRCM, Giens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application of Smartphone

Device

Weekly questionnaire on smartphone

No application Smartphone

Other

No weekly questionnaire on smartphone

Primary outcomes

  1. Frequency of exacerbation

    Time frame: up to 6 months

Secondary outcomes

  1. Satisfactory status and compliance

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: MUSE

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 24, 2014
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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