Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Data collection about asthma control, quality of life and spirometry will be managed through DragONE, a downloadable APP for smartphones.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEP-CASES | Other | 25 Case Patients will follow the Therapeutic Education to the Patient (TEP). In addition the following procedures will be performed:
|
|
| TEP-CONTROLS | No Intervention | 25 Control Patients will follow the usual care program:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Education to the Patient (TEP) | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council | Palermo | Sicily | 90146 | Italy |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C072829 | tetraethylpyrazine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| 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 |
| Presence of Cotinine and Nicotine from Hair and Urine analysis respectively | 2 YEARS |
| Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis | 2 YEARS |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |