DragONE Study: Acquisition and Maintenance of Paediatric... | NCT03273933

Studies
DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices

NCT03273933

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Status

Completed

Last Update Posted

Jun 9, 2020Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Asthma

Interventions

DragONE
SmartOne

Countries

Italy

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 8, 2018Actual

Primary Completion Date

Feb 26, 2020Actual

Completion Date

Feb 26, 2020Actual

First Submitted Date

Sep 5, 2017

First Submission Date that Met QC Criteria

Sep 5, 2017

First Posted Date

Sep 6, 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

Jun 5, 2020

Last Update Posted Date

Jun 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stefania La Grutta, MD, Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy., Istituto per la Ricerca e l'Innovazione BiomedicaPrincipal Investigator

Lead Sponsor

Istituto per la Ricerca e l'Innovazione BiomedicaOTHER

Collaborators

Not provided

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

Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control through innovative devices supporting usual care. In the first study arm, a new application (DragONE) for iOS and Android will be only used for patient monitoring. In the second study arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every 4 weeks for 12 weeks.

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
10 children with DragONE only	Active Comparator		Device: DragONE
10 children with DragONE and SmartOne	Experimental		Device: DragONE Device: SmartOne

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DragONE	Device	The DragONE application for iOS and Android, developed in collaboration with the Institute for Educational Technologies of the National Research Council of Palermo, allow children to daily fill electronically the C-ACT questionnaire and the symptom diary card.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acquisition and maintenance of the control status	mean C-ACT score	Once every 4 weeks, for 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Quality of life in asthma children	PAQLQ score	12 weeks
Adherence to asthma treatment	MARS score	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of moderate persistent asthma
Uncontrolled symptoms (C-ACT≤ 19)
Treated for at least 3 months
FEV1 between 60% and 90% of predicted value

Exclusion Criteria:

Symptoms of acute respiratory infection
Immunological or metabolic systemic disease
Major malformations of the upper airways
Active smoker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo		Palermo		90146	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided