Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Stefania La Grutta, MD
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Stefania La Grutta, MD
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 Biomedica
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
Outcomes
Primary Outcomes
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
Time Frame: 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 Outcomes
- Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children(2 YEARS)
- Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children(2 YEARS)
- 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)
- Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis(2 YEARS)