NCT01979224

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Feb 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
Last Updated

November 8, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

May 30, 2013

Last Update Submit

October 31, 2013

Conditions

Keywords

educational intervention, Asthma control, asthma knowledge

Outcome Measures

Primary Outcomes (1)

  • asthma control

    9 months

Study Arms (1)

treatment and routine counseling

NO INTERVENTION

Parents attend regular consultation and receive regular medical guidance

Other: Educational intervention for parents

Interventions

educational sessions once a week two hours for a month and later educational reinforcement and monitoring asthma control monthly for nine months

Also known as: Educational intervention for parents of children with asthma
treatment and routine counseling

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Blanca ZM master

    Universidad Autónoma de San Luis Potosí México

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Efficacy of educational intervention for parents of children with asthma in 4-11 years and their impact on the control as measured by childern Asthma Control Test (ACT). Randomized Controlled Clinical

Study Record Dates

First Submitted

May 30, 2013

First Posted

November 8, 2013

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2013

Last Updated

November 8, 2013

Record last verified: 2013-10