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Efficacy of Educational Intervention for Parents of Children With Asthma

31. oktober 2013 opdateret af: Blanca Nohemí Zamora Mendoza, Universidad Autonoma de San Luis Potosí

Efficacy of Educational Intervention for Parents of Children With Asthma in 4-11 Years and Their Impact on the Control Children as Measured by ACT. Randomized Controlled Clinical

Introduction. Asthma is a chronic inflammatory disorder of the airways, identified by airflow obstruction. Unfortunately only 2.4% of American asthmatics meet internationally recommended criteria for control. The lack of knowledge in parents of asthmatic children has been a direct result of minimum or no control at all, so the educational programs need to be assessed in terms of improvement of the control. Target. To determine whether an educational intervention aimed at parents of asthmatic children 4 to 11 years improved clinical control measured by Test Childhood Asthma Control. Material and Methods. Randomized controlled clinical trial in 42 patients randomly divided into two groups that were evaluated in the same time knowledge and control of asthma, a measurement was performed at baseline and monthly for nine months. The experimental group attended an educational intervention for individual reinforcements through this period, the control group was only monitored

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  • Recruitment of patients that attended hospital's emergency gate due to asthma issues, and phone calls to regular physicians patients.
  • Once recruited all parents of patients were asked to participate in the study where their children will be evaluated on an asthma control and asked informed consent
  • The clinical history, spirometry and / or basal peak flow Diagnostic concordance
  • With the collected data was performed a database clinical history, ACT score, FEV1 and PEF, results of each patient and personal data for future location, the base was used for the concordance of diagnosis.
  • Once the sample that met the selection criteria were formed experimental and control groups at random using "R Project Statistical Computing" 2.12.2 version performed by the statistical
  • The experimental group was invited to participate in educational sessions two hours at week in just one month and monthly individual reinforcements through the evaluation period.
  • Educational sessions were based on the Global Initiative for Asthma (GINA), Guía Española para el Manejo del Asma (GEMA) And Concenso Mexicano de Asma.
  • Those measurements were performed by an external partner or educators or the attending physician performed to avoid biased results.

The monthly ACT and peak flow of the attending physician were blinded

variables:

  • educational intervention, with and without intervention
  • asthma control: measured by infant ACT
  • time: 0 to 9 months
  • sex: female or male
  • Age: 4 to 11 years

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

4 år til 11 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Eligibility Criteria

  • Children 4-11 years with diagnosed asthma with parents attending the outpatient pediatric pneumology and pediatric emergency because of acute asthma in General Hospital de Soledad.
  • Patients with a baseline score less than 27 points in childhood ACT
  • Patients with Government Health Insurance. (to ensure access to medication and medical care)
  • Parents who can read and write
  • Parents willing and able to participate
  • Parents who do not belong or have been part of an educational program on asthma by asthma clinic.

Exclusion Criteria

- Parents with children having other comorbidities that prevent or hinder proper control of asthma, such as Cerebral Palsy, (PCI) psychomotor retardation, psychiatric Sd. Down, congenital malformations, which alter the chest wall, obesity, nasal polyp.

Elimination criteria

  • Parents who fail to attend 50% of the sessions given (since it does not allow parents to acquire sufficient knowledge to significantly improve the control of asthma as GEMA educational guidance)
  • Patients and parents who decide not to continue in the project.
  • Patients who develop pulmonary comorbidities over a month of evolution and lung tissue affecting significantly, as syncytial respiratory virus, pneumonia, tuberculosis, and asthma control difficulties.
  • Patients who leave or do not take the prescribed treatment by physician for a month.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: treatment and routine counseling
Parents attend regular consultation and receive regular medical guidance
Andet: Educational intervention for parents
educational sessions once a week two hours for a month and later educational reinforcement and monitoring asthma control monthly for nine months
Andre navne:
  • Educational intervention for parents of children with asthma

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
asthma control
Tidsramme: 9 months
9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad Autonoma de San Luis Potosí

Samarbejdspartnere

Hospital General de Soledad de Graciano Sánchez, SLP, MX

Efterforskere

  • Ledende efterforsker: Blanca ZM master, Universidad Autónoma de San Luis Potosí México

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2012

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

30. maj 2013

Først indsendt, der opfyldte QC-kriterier

31. oktober 2013

Først opslået (Skøn)

8. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A-001
  • UASLP-001 (Registry Identifier: UASLP-001)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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