Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, 90146, Italy
NCT Number: NCT02636920
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.
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Notify Me6 year–11 year
All sexes
Interventional
Not applicable
Palermo, Sicily, 90146, 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: TEP
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 2 YEARS
Time frame: 2 YEARS
Stefania La Grutta, MD
Other
Acronym: TEP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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