NCT02636920

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Stefania La Grutta, MD · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Therapeutic Education to the Patient (TEP)	* Educational Diagnosis, asking what patient has, what he knows, what he is doing, what he would like to do. * Therapeutic Contract, to define objectives to reach at the end of educational path, integrating new knowledges and replacing wrong cognitive-behavior models with new schemes. * Educational Therapeutic Intervention, with individual or group methodologies (Role Playing, Brain Storming) and a disease diary in which patients could describe symptoms, therapies, behaviors and benefits. * Assessing of the knowledges acquired by patients.

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2015-12-22
• Last updated: 2020-12-19

Locations

1 site across 1 country: Italy