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Efficacy of Educational Intervention for Parents of Children With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational intervention for parents
Sponsored by
Universidad Autonoma de San Luis Potosí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring educational intervention, Asthma control, asthma knowledge

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    treatment and routine counseling

    Arm Description

    Parents attend regular consultation and receive regular medical guidance

    Outcomes

    Primary Outcome Measures

    asthma control

    Secondary Outcome Measures

    Full Information

    First Posted
    May 30, 2013
    Last Updated
    October 31, 2013
    Sponsor
    Universidad Autonoma de San Luis Potosí
    Collaborators
    Hospital General de Soledad de Graciano Sánchez, SLP, MX
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01979224
    Brief Title
    Efficacy of Educational Intervention for Parents of Children With Asthma
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    October 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autonoma de San Luis Potosí
    Collaborators
    Hospital General de Soledad de Graciano Sánchez, SLP, MX

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    educational intervention, Asthma control, asthma knowledge

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment and routine counseling
    Arm Type
    No Intervention
    Arm Description
    Parents attend regular consultation and receive regular medical guidance
    Intervention Type
    Other
    Intervention Name(s)
    Educational intervention for parents
    Other Intervention Name(s)
    Educational intervention for parents of children with asthma
    Intervention Description
    educational sessions once a week two hours for a month and later educational reinforcement and monitoring asthma control monthly for nine months
    Primary Outcome Measure Information:
    Title
    asthma control
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Blanca ZM master
    Organizational Affiliation
    Universidad Autónoma de San Luis Potosí México
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Efficacy of Educational Intervention for Parents of Children With Asthma

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