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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03292718
Recruitment Status : Not yet recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment
Cystic Fibrosis in Children Device: MyCyFAPP

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group, open label, with intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Anticipated Study Start Date : October 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: use of MyCyFAPP
use of MyCyFAPP during 6 months
Device: MyCyFAPP
use of the MycyFAPP with all its features during 6 months


Outcome Measures

Primary Outcome Measures :
  1. change in Modified PedsQL GI [ Time Frame: 3 months ]
    Modified PedsQL GI will be assessed at month 0 and month 3 by applying questionnaires to children and their parents


Secondary Outcome Measures :
  1. change in CFQ-R [ Time Frame: 3 months and 6 months ]
    CFQ-R will be assessed by questionnaires

  2. change in VAS [ Time Frame: 3 months and 6 months ]
    VAS will be assessed by questionnaires

  3. change in Modified PedsQL GI [ Time Frame: 6 months ]
    Modified PedsQL GI will be assessed at month 0 and month 6 by applying questionnaires to children and their parents

  4. change in lung function [ Time Frame: 3 and 6 months ]
    spirometry will be performed


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following 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:

  1. Acute infection associated with decreased appetite or fever at time of run-in visit
  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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292718


Contacts
Contact: Mieke Boon, MD PhD +3216343820 mieke.boon@uzleuven.be

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Hospital Universitario La Fe
European Commission
More Information

Additional Information:
Responsible Party: Mieke Boon, MD PhD, Mieke Boon, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03292718     History of Changes
Other Study ID Numbers: s60787
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mieke Boon, MD PhD, Universitaire Ziekenhuizen Leuven:
PERT
mobile application

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases