Trials / Unknown
UnknownNCT03292718
Clinical Trial to Assess Influence of MyCyFAPP Use on GI Related QOL in Children With Cystic Fibrosis
Innovative Approach for Self-management and Social Welfare of Cystic Fibrosis Patients in Europe: Development, Validation and Implementation of a Telematics Tool. WP6.2: Impact Assessment Through a European Multicentre Clinical Trial: Validation of MyCyFAPP as a Portable System for Self-management in Children With CF
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MyCyFAPP | use of the MycyFAPP with all its features during 6 months |
Timeline
- Start date
- 2017-10-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2017-09-25
- Last updated
- 2017-09-25
Source: ClinicalTrials.gov record NCT03292718. Inclusion in this directory is not an endorsement.