Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children (TEP)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Sicily
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Palermo, Sicily, Itália, 90146
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: TEP-CASES
25 Case Patients will follow the Therapeutic Education to the Patient (TEP). In addition the following procedures will be performed:
|
Outros nomes:
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Sem intervenção: TEP-CONTROLS
25 Control Patients will follow the usual care program:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
Prazo: 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. |
2 YEARS
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children
Prazo: 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 YEARS
|
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Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children
Prazo: 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) |
2 YEARS
|
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Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children
Prazo: 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). |
2 YEARS
|
|
Presence of Cotinine and Nicotine from Hair and Urine analysis respectively
Prazo: 2 YEARS
|
2 YEARS
|
|
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Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis
Prazo: 2 YEARS
|
2 YEARS
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 8/2014-
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