Clinical Trial to Assess Influence of MyCyFAPP Use on GI Related QOL in Children With Cystic Fibrosis
NCT ID: NCT03292718
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2017-10-31
2018-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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use of MyCyFAPP
use of MyCyFAPP during 6 months
MyCyFAPP
use of the MycyFAPP with all its features during 6 months
Interventions
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MyCyFAPP
use of the MycyFAPP with all its features during 6 months
Eligibility Criteria
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Inclusion Criteria
1. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
2. A documented genotype with two disease-causing mutations in the CFTR gene
2. Having pancreatic insufficiency (stool elastase \< 200 mcg/g stool) and using PERT
3. Age ≥ 24 months and \< 18 years at screening visit
4. Informed consent by parent or legal guardian; assent for children from age 12 years on
6\. Inclusion visit coincides with scheduled routine clinic visit 7. Ability and willingness to comply with APP use and evaluations at time of routine clinic visits as judged by the site investigator 8. Availability of wifi connection at home so that connection to the internet is feasible at home at least weekly.
Exclusion Criteria
2. Acute abdominal pain necessitating an intervention at time of run-in visit
3. Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator
4. Investigational drug use within 30 days prior to run-in visit
5. Started with CFTR modulator treatment less than 3 months before start of run-in visit
6. Inability to use the APP due to patient specific factors such as language or learning difficulties
2 Years
18 Years
ALL
No
Sponsors
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Hospital Universitario La Fe
OTHER
European Commission
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Mieke Boon, MD PhD
Mieke Boon
Central Contacts
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Related Links
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Related Info
Other Identifiers
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s60787
Identifier Type: -
Identifier Source: org_study_id