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Muco Smartphone Exacerbation (MUSE)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status and phase

Completed
Early Phase 1

Conditions

Cystic Fibrosis

Treatments

Other: No application Smartphone
Device: Application of Smartphone

Study type

Interventional

Funder types

Other

Identifiers

NCT02122289
9172 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

14 to 25 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups, including a placebo group

Application of Smartphone
Experimental group
Description:
Weekly questionnaire on Smartphone
Treatment:
Device: Application of Smartphone
No application Smartphone
Placebo Comparator group
Description:
No Weekly questionnaire on Smartphone
Treatment:
Other: No application Smartphone

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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