Clinical Trial to Assess Influence of MyCyFAPP Use on GI... | NCT03292718

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

NCT03292718

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Sep 25, 2017Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Cystic Fibrosis in Children

Interventions

MyCyFAPP

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2017Estimated

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Sep 20, 2017

First Submission Date that Met QC Criteria

Sep 20, 2017

First Posted Date

Sep 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2017

Last Update Posted Date

Sep 25, 2017Actual

Name	Class
Hospital Universitario La Fe	OTHER
European Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
use of MyCyFAPP	Experimental	use of MyCyFAPP during 6 months	Device: MyCyFAPP

Name	Type	Description	Arm Group Labels	Other Names
MyCyFAPP	Device	use of the MycyFAPP with all its features during 6 months	use of MyCyFAPP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in Modified PedsQL GI	Modified PedsQL GI will be assessed at month 0 and month 3 by applying questionnaires to children and their parents	3 months

Secondary Outcomes

Measure	Description	Time Frame
change in CFQ-R	CFQ-R will be assessed by questionnaires	3 months and 6 months
change in VAS	VAS will be assessed by questionnaires

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
Having pancreatic insufficiency (stool elastase < 200 mcg/g stool) and using PERT
Age ≥ 24 months and < 18 years at screening visit
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:

Acute infection associated with decreased appetite or fever at time of run-in visit
Acute abdominal pain necessitating an intervention at time of run-in visit
Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator
Investigational drug use within 30 days prior to run-in visit
Started with CFTR modulator treatment less than 3 months before start of run-in visit
Inability to use the APP due to patient specific factors such as language or learning difficulties

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided