Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

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.
    

Intervention name(s): Therapeutic Education to the Patient (TEP)
Intervention type(s): Other
Intervention description(s): 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 name(s): TEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Asthma; Children