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
About this trial
This is an interventional supportive care trial for Cystic Fibrosis focused on measuring Exacerbation, QoL
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
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
NCT ID
NCT02122289
First Posted
April 22, 2014
Last Updated
April 11, 2016
Sponsor
University Hospital, Montpellier
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
Learn more about this trial
Muco Smartphone Exacerbation
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