Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children
NCT ID: NCT02636920
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2017-03-01
2017-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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TEP-CASES
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)
Therapeutic Education to the Patient (TEP)
* Educational Diagnosis, asking what patient has, what he knows, what he is doing, what he would like to do.
* Therapeutic Contract, to define objectives to reach at the end of educational path, integrating new knowledges and replacing wrong cognitive-behavior models with new schemes.
* Educational Therapeutic Intervention, with individual or group methodologies (Role Playing, Brain Storming) and a disease diary in which patients could describe symptoms, therapies, behaviors and benefits.
* Assessing of the knowledges acquired by patients.
TEP-CONTROLS
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)
No interventions assigned to this group
Interventions
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Therapeutic Education to the Patient (TEP)
* Educational Diagnosis, asking what patient has, what he knows, what he is doing, what he would like to do.
* Therapeutic Contract, to define objectives to reach at the end of educational path, integrating new knowledges and replacing wrong cognitive-behavior models with new schemes.
* Educational Therapeutic Intervention, with individual or group methodologies (Role Playing, Brain Storming) and a disease diary in which patients could describe symptoms, therapies, behaviors and benefits.
* Assessing of the knowledges acquired by patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Immunologic and metabolic systemic disease
* Major malformation of upper respiratory tract
* Active smokers patients
6 Years
11 Years
ALL
No
Sponsors
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Stefania La Grutta, MD
OTHER
Responsible Party
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Stefania La Grutta, MD
Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Locations
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Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, Italy
Countries
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Other Identifiers
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8/2014-
Identifier Type: -
Identifier Source: org_study_id