- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02636920
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Sicily
-
Palermo, Sicily, Italia, 90146
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: TEP-CASES
25 Case Patients will follow the Therapeutic Education to the Patient (TEP). In addition the following procedures will be performed:
|
Andre navn:
|
Ingen inngripen: TEP-CONTROLS
25 Control Patients will follow the usual care program:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 2 YEARS
|
2 YEARS
|
|
Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis
Tidsramme: 2 YEARS
|
2 YEARS
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 8/2014-
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