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

Stefania La Grutta, MD

Status: Completed

Conditions: Asthma

Treatments: Other: Therapeutic Education to the Patient (TEP)

Study type: Interventional

Funder types: Other

Identifiers

NCT02636920

8/2014-

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

TEP-CASES

Other group

Description:

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)

Treatment:

Other: Therapeutic Education to the Patient (TEP)

TEP-CONTROLS

No Intervention group

Description:

25 Control Patients will follow the usual care program: * The Pediatric Asthma Quality of Life Questionnaire (PAQLQ); * The Children Asthma Control Test (C-ACT); * the 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)