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

June 5, 2020 updated by: Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90146
        • Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 10 children with DragONE only
Device: DragONE
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.
EXPERIMENTAL: 10 children with DragONE and SmartOne
Device: DragONE
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.
Device: SmartOne
A little portable spirometer connected to DragONE allows daily PEF monitoring.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in asthma children
Time Frame: 12 weeks
PAQLQ score
12 weeks
Adherence to asthma treatment
Time Frame: 12 weeks
MARS score
12 weeks
Lung function: FEV1
Time Frame: 12 weeks
Forced expiratory volume in the first second
12 weeks
Lung function: FVC
Time Frame: 12 weeks
Forced vital capacity
12 weeks
Lung function: FEF 25-75
Time Frame: 12 weeks
Forced expiratory flow at 25-75%
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 8, 2018

Primary Completion (ACTUAL)

February 26, 2020

Study Completion (ACTUAL)

February 26, 2020

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (ACTUAL)

September 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 5, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7/2017_B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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