Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children (TEP)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Sicily
-
Palermo, Sicily, Italia, 90146
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: TEP-CASES
25 Case Patients will follow the Therapeutic Education to the Patient (TEP). In addition the following procedures will be performed:
|
Altri nomi:
|
|
Nessun intervento: TEP-CONTROLS
25 Control Patients will follow the usual care program:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
Lasso di tempo: 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. |
2 YEARS
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children
Lasso di tempo: 2 YEARS
|
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
|
|
Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children
Lasso di tempo: 2 YEARS
|
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
Lasso di tempo: 2 YEARS
|
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
Lasso di tempo: 2 YEARS
|
2 YEARS
|
|
|
Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis
Lasso di tempo: 2 YEARS
|
2 YEARS
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 8/2014-
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .