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Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children (TEP)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Therapeutic Education to the Patient (TEP)
Sponsored by
Stefania La Grutta, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma, Children

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

TEP-CASES

TEP-CONTROLS

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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)
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).
Presence of Cotinine and Nicotine from Hair and Urine analysis respectively
Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis

Full Information

First Posted
October 30, 2015
Last Updated
December 16, 2020
Sponsor
Stefania La Grutta, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02636920
Brief Title
Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children
Acronym
TEP
Official Title
Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stefania La Grutta, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEP-CASES
Arm Type
Other
Arm Description
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)
Arm Title
TEP-CONTROLS
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Therapeutic Education to the Patient (TEP)
Other Intervention Name(s)
TEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
Description
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
Secondary Outcome Measure Information:
Title
Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children
Description
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
Title
Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children
Description
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
Title
Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children
Description
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
Title
Presence of Cotinine and Nicotine from Hair and Urine analysis respectively
Time Frame
2 YEARS
Title
Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis
Time Frame
2 YEARS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
City
Palermo
State/Province
Sicily
ZIP/Postal Code
90146
Country
Italy

12. IPD Sharing Statement

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Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children

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