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

Asthma Clinical Trial

— TEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636920
• Other study ID #: 8/2014-
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: December 2020
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council	Palermo	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
Stefania La Grutta, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children	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.	2 YEARS
Secondary	Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children	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)	2 YEARS
Secondary	Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children	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)	2 YEARS
Secondary	Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children	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).	2 YEARS
Secondary	Presence of Cotinine and Nicotine from Hair and Urine analysis respectively		2 YEARS
Secondary	Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis		2 YEARS