Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

16. desember 2020 oppdatert av: Stefania La Grutta, MD

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Sicily
      • Palermo, Sicily, Italia, 90146
        • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år til 11 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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)
  • 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.
Andre navn:
  • TEP
Ingen inngripen: 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)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children
Tidsramme: 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
Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children
Tidsramme: 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
Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children
Tidsramme: 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
Tidsramme: 2 YEARS
2 YEARS
Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis
Tidsramme: 2 YEARS
2 YEARS

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2017

Primær fullføring (Faktiske)

31. august 2017

Studiet fullført (Faktiske)

31. august 2017

Datoer for studieregistrering

Først innsendt

30. oktober 2015

Først innsendt som oppfylte QC-kriteriene

18. desember 2015

Først lagt ut (Anslag)

22. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. desember 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. desember 2020

Sist bekreftet

1. desember 2020

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

3
Abonnere