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NCT05555134 Clinical Trial

INHALATION CHAMBER MANAGEMENT IN PEDIATRICS: EFFICACY OF AN EDUCATIONAL INTERVENTION IN PATIENTS DIAGNOSED WITH BRONCHOSPASM AND THEIR FAMILY CAREGIVERS.

Bronchospasm Clinical Trial

Official title:
INHALATION CHAMBER MANAGEMENT IN PEDIATRICS: EFFICACY OF AN EDUCATIONAL INTERVENTION IN PATIENTS DIAGNOSED WITH BRONCHOSPASM AND THEIR FAMILY CAREGIVERS.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05555134
Other study ID # PuertadeHierro.
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 1, 2021
Est. completion date October 2024

Study information
Verified date September 2022
Source Puerta de Hierro University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Several studies show that unnecessary and frequent visits to the emergency department for bronchospasm care are associated with inadequate management of inhalers and poor education on the approach to respiratory distress. Main objective: To determine the degree of frequentation to the pediatric emergency department for bronchospasm at 1, 3 and 6 months after the educational intervention. Design: Randomized controlled clinical trial with two groups: EXPERIMENTAL will receive the educational intervention, along with usual care, and CONTROL will receive usual care. Subjects: pediatric patients (2-15 years) diagnosed with bronchospasm; in home treatment with inhalation chambers; and their parents. Emergency Department recruitment. Follow-up at home

Recruitment information / eligibility
Status Recruiting
Enrollment 121
Est. completion date October 2024
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 15 Years
Eligibility Inclusion Criteria: - Patients between 2-15 years of age attending the Pediatric Emergency Department of the Hospital Universitario Puerta de Hierro Majadahonda (HUPHM) with a mild, moderate or severe bronchospasm crisis and who have used the inhalation chambers on at least one occasion; with autonomy in the use of the inhalation chambers at home Exclusion Criteria: - Not understanding Spanish

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• educational intervention
will also have an extra educational intervention, a group intervention (4-6 people) through a one-hour training session via zoom, which will be given by the PI (extensive experience in the subject) a week after discharge from the ER. Information will be reinforced and doubts will be solved

Locations
Country Name City State
Spain Belén de la Rosa Majadahonda Madrid

Sponsors (1)
Lead Sponsor Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary degree of frequentation to the emergency department 6 months
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