Muco Smartphone Exacerbation

NCT02122289 | Completed Early Phase 1

• 1 other identifier: 9172
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis

Keywords

Exacerbation, QoL

Outcome Measures

Primary Outcomes (1)

• Frequency of exacerbation

  up to 6 months

Secondary Outcomes (1)

• Satisfactory status and compliance

  up to 6 months

Study Arms (2)

Application of Smartphone

EXPERIMENTAL

Weekly questionnaire on Smartphone

Device: Application of Smartphone

No application Smartphone

PLACEBO COMPARATOR

No Weekly questionnaire on Smartphone

Other: No application Smartphone

Interventions

Application of Smartphone DEVICE

Weekly questionnaire on smartphone

Application of Smartphone

No application Smartphone OTHER

No weekly questionnaire on smartphone

No application Smartphone

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients who are include in an interventional study
• Patient who is not able to read French language
• Patients with psychological disorder

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

CRCM

Giens, France

Location

CRCM

Montpellier, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Raphael CHIRON

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 24, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

FR (2)