MUSE: Muco Smartphone Exacerbation

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT02122289
• Collaborator: (none)
• Enrollment: 45
• Locations: 2
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 22.5
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Device: Application of Smartphone; Other: No application Smartphone	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Interest of the New Technologies to Detect précocément a Respiratory Exacerbation at Patients Reached by Cystic Fibrosis.
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Application of Smartphone Weekly questionnaire on Smartphone	Device: Application of Smartphone; Weekly questionnaire on smartphone
Placebo Comparator: No application Smartphone No Weekly questionnaire on Smartphone	Other: No application Smartphone; No weekly questionnaire on smartphone

Outcome Measures

Primary Outcome Measures

1. Frequency of exacerbation [up to 6 months]

Secondary Outcome Measures

1. Satisfactory status and compliance [up to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRCM	Giens		France
2	CRCM	Montpellier		France

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

• Principal Investigator: Raphael CHIRON, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT02122289
• Other Study ID Numbers: 9172
• First Posted: Apr 24, 2014
• Last Update Posted: Apr 12, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by University Hospital, Montpellier: Exacerbation, QoL
• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of Apr 12, 2016