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Muco Smartphone Exacerbation (MUSE)

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Application of Smartphone
No application Smartphone
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cystic Fibrosis focused on measuring Exacerbation, QoL

Eligibility Criteria

14 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CRCM
  • CRCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Application of Smartphone

No application Smartphone

Arm Description

Weekly questionnaire on Smartphone

No Weekly questionnaire on Smartphone

Outcomes

Primary Outcome Measures

Frequency of exacerbation

Secondary Outcome Measures

Satisfactory status and compliance

Full Information

First Posted
April 22, 2014
Last Updated
April 11, 2016
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02122289
Brief Title
Muco Smartphone Exacerbation
Acronym
MUSE
Official Title
Interest of the New Technologies to Detect précocément a Respiratory Exacerbation at Patients Reached by Cystic Fibrosis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Exacerbation, QoL

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Application of Smartphone
Arm Type
Experimental
Arm Description
Weekly questionnaire on Smartphone
Arm Title
No application Smartphone
Arm Type
Placebo Comparator
Arm Description
No Weekly questionnaire on Smartphone
Intervention Type
Device
Intervention Name(s)
Application of Smartphone
Intervention Description
Weekly questionnaire on smartphone
Intervention Type
Other
Intervention Name(s)
No application Smartphone
Intervention Description
No weekly questionnaire on smartphone
Primary Outcome Measure Information:
Title
Frequency of exacerbation
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Satisfactory status and compliance
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael CHIRON
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRCM
City
Giens
Country
France
Facility Name
CRCM
City
Montpellier
Country
France

12. IPD Sharing Statement

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Muco Smartphone Exacerbation

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