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Clinical Trial to Assess Influence of MyCyFAPP Use on GI Related QOL in Children With Cystic Fibrosis

NCT03292718 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-09-25

No results posted yet for this study

Summary

Interventional trial to study the influence of the use of MyCyFAPP (mobile application) on the gastro-intestinal related quality of life.

This mobile APP has been developed during previous workpackages of the Horizon2020 Project and contains several modules:

* mathematical prediction model to calculate the needed dose for pancreatic enzyme replacement therapy
* educational games and other educational material
* communication with doctor/dietician through professional webtool
* diary to register symptoms and data on nutrition.

The app will be introduced and used during 6 months. Primary outcome parameter will be change in modified PedsQL GI after 3 months. PedsQL GI is an existing questionnaire that evaluates gastro-intestinal related quality of life in children. We validated it for use in cystic fibrosis in a previous observational study.

Conditions

  • Cystic Fibrosis in Children

Interventions

DEVICE

MyCyFAPP

use of the MycyFAPP with all its features during 6 months

Sponsors & Collaborators

  • Hospital Universitario La Fe

    collaborator OTHER

  • European Commission

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-12-31
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03292718 on ClinicalTrials.gov