NCT02636920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

October 30, 2015

Last Update Submit

December 16, 2020

Conditions

Asthma

Keywords

AsthmaChildren

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 YEARS

Secondary Outcomes (5)

  • Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children

    2 YEARS

  • Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children

    2 YEARS

  • Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children

    2 YEARS

  • Presence of Cotinine and Nicotine from Hair and Urine analysis respectively

    2 YEARS

  • Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis

    2 YEARS

Study Arms (2)

TEP-CASES

OTHER

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)

Other: Therapeutic Education to the Patient (TEP)

TEP-CONTROLS

NO INTERVENTION

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)

Interventions

Therapeutic Education to the Patient (TEP)OTHER

* 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.

Also known as: TEP
TEP-CASES

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of asthma

You may not qualify if:

  • Acute respiratory infection signs
  • Immunologic and metabolic systemic disease
  • Major malformation of upper respiratory tract
  • Active smokers patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Palermo, Sicily, 90146, Italy

Location

MeSH Terms

Conditions

Asthma

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
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.

Study Record Dates

First Submitted

October 30, 2015

First Posted

December 22, 2015

Study Start

March 1, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

December 19, 2020

Record last verified: 2020-12

Locations

IT(1)