Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Therapeutic Education to the Patient (TEP)

• Registration Number: NCT02636920
• Lead Sponsor: Stefania La Grutta, MD

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.

Study Timeline

• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-12-18
• Study First Posted: 2015-12-22
• Study Start: 2017-03-01
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEP-CASES	Therapeutic Education to the Patient (TEP)	25 Case Patients will follow the Therapeutic Education to the Patient (TEP). In addition 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); * 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)

Primary Outcome Measures

Name	Time	Method
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children	2 YEARS	The main objective is to measure the impact of the program on the QOL of asthmatic primary-school aged children seen for the first time in consultation with a pediatric pulmonologist.; QOL of the children, will be assessed by Pediatric Asthma Quality of Life Questionnaire, PAQLQ.

Secondary Outcome Measures

Name	Time	Method
Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children	2 YEARS	The secondary objective is to assess the effects of the program on asthma management.; Asthma management will be assessed by Childhood Asthma Control Test (C-ACT)
Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children	2 YEARS	The secondary objective is to assess the effects of the program on parameters of functional respiratory tests.(FRT).; FRT will be assessed by forced expiratory volume in one second (FEV1), forced expiratory flow between 25% and 75% (FEF 25-75), the forced vital capacity (FVC) and Peak expiratory flow (PEF).
Presence of Cotinine and Nicotine from Hair and Urine analysis respectively	2 YEARS
Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children	2 YEARS	The secondary objective is to assess the effects of the program on the QOL of parents.; QOL of the accompanying parent will be assessed by the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis	2 YEARS

Trial Locations

Locations (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council; 🇮🇹 Palermo, Sicily, Italy