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

• Sponsor: Stefania La Grutta, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT02636920
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 8.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Other: Therapeutic Education to the Patient (TEP)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Aug 31, 2017
• Actual Study Completion Date: Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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)	Other: 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 Names: TEP
No Intervention: 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)

Outcome Measures

Primary Outcome Measures

1. Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children [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.

Secondary Outcome Measures

1. Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children [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. Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children [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)

3. Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children [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).

4. Presence of Cotinine and Nicotine from Hair and Urine analysis respectively [2 YEARS]

5. Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis [2 YEARS]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council	Palermo	Sicily	Italy	90146

Sponsors and Collaborators

• Stefania La Grutta, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 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., Istituto per la Ricerca e l'Innovazione Biomedica
• ClinicalTrials.gov Identifier: NCT02636920
• Other Study ID Numbers: 8/2014-
• First Posted: Dec 22, 2015
• Last Update Posted: Dec 19, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by 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., Istituto per la Ricerca e l'Innovazione Biomedica: Asthma; Children
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Dec 19, 2020