Clinical trial NCT02636920: Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children
Official title: Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Children
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: It is an interventional prospective study. The study will assess the intervention of the "Therapeutic Education to the Patient (TEP)" on the quality of life in asthmatic children.

The patients will be enrolled from the 1st of May 2016 to the 31st of December 2016 in the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

Detailed description: It is an interventional prospective study. The study will assess the intervention of the "Therapeutic Education to the Patient (TEP)" on the quality of life in asthmatic children.

The patients will be enrolled from the 1st of May 2016 to the 31st of December 2016 in the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

25 Case Patients will follow the Therapeutic Education to the Patient (TEP) and 25 Control Patients will follow the usual care program.

The following procedures will be performed:

* Pediatric Asthma Quality of Life Questionnaire (PAQLQ);
* Children Asthma Control Test (C-ACT);
* Pediatric Caregiver Asthma Quality of Life Questionnaire (PCAQLQ);
* Familiar Empowerment Scale (FES);
* Functional respiratory tests: forced expiratory volume in one second (FEV1), forced expiratory flow between 25% and 75% (FEF 25-75), forced vital capacity (FVC) and Peak expiratory flow (PEF); in addition, FEV1 and PEF will be daily recorded through the SmartOne device (Medical International Research s.r.l.), a portable flow peak meter for smartphones;
* Evaluation of the presence of Cotinine and Nicotine from Hair and Urine analysis respectively;
* Evaluation of levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis.

Data collection about asthma control, quality of life and spirometry will be managed through DragONE, a downloadable APP for smartphones.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma

Exclusion Criteria:

* Acute respiratory infection signs
* Immunologic and metabolic systemic disease
* Major malformation of upper respiratory tract
* Active smokers patients

Primary outcomes:
measure: Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
timeFrame: 2 YEARS
Secondary outcomes:
measure: Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children
timeFrame: 2 YEARS
measure: Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children
timeFrame: 2 YEARS
measure: Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children
timeFrame: 2 YEARS
measure: Presence of Cotinine and Nicotine from Hair and Urine analysis respectively
timeFrame: 2 YEARS
measure: Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis
timeFrame: 2 YEARS
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
state: Sicily
Study officials:
References: