Randomised Controlled Trial of a Multi-faceted Community-based Intervention to Improve Asthma in Children
1 other identifier
interventional
298
1 country
1
Brief Summary
The objectives of this trials are to demonstrate, in children with poorly controlled asthma, that an intervention to increase the awareness and the impact of poor asthma control among parents and physicians of affected children and adolescents can reduce the rate of asthma emergency visits in the 12 months following the initiation of the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Aug 2002
Longer than P75 for phase_4 asthma
1 active site
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
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 12, 2005
CompletedFirst Posted
Study publicly available on registry
October 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 20, 2017
April 1, 2017
4.7 years
October 12, 2005
April 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of emergency department (ED) visits per person-month of observation, derived from Quebec provincial database (RAMQ) data.
rate of ED visit derived from provincial administrative databases
1 year
Secondary Outcomes (4)
Usage of asthma medication (refill rate of reliever drugs, ratio of reliever/preventer drugs; rate of rescue systemic steroids) as assessed from pharmacy records and RAMQ data
1 year after randomisation
Quality of life of the child and caregivers using Juniper's instruments
1 year after randomisation
Change in asthma control between baseline and 12 months
1 year after randomisation
Health care resources utilisation for asthma care (hospitalisation for asthma, hospitalisation for any cause, ratio of clinic to emergency department, as reflection of the ratio of preventive over curative care).
1 year after randomisation
Study Arms (2)
Asthma control awareness
EXPERIMENTALMultifaceted intervention to increase the patient awareness of the leve of asthma control
Usual care
ACTIVE COMPARATORUsual care
Interventions
Repeated assessments of the child's asthma control using the Asthma Quiz for Kidz, with recommendation for asthma education and medical visit
Recommendation for asthma education and/or follow-up at the physician's discretion
Eligibility Criteria
You may qualify if:
- Children between 6 and 17 years of
- acute asthma requiring emergency room visit or hospital admission
- understanding of French or English
You may not qualify if:
- the index exacerbation is the first episode of wheezing in the previous year,
- there is co-existence of other chronic pulmonary (such as Bronchopulmonary dysplasia (BPD), cystic fibrosis (CF)), renal or cardiac diseases;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ste-Justine Hospital
Montreal, Quebec, H3T 1C5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francine M. Ducharme, MD, MSc
CHUS-Ste Justine Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Francine Ducharme
Study Record Dates
First Submitted
October 12, 2005
First Posted
October 14, 2005
Study Start
August 1, 2002
Primary Completion
April 1, 2007
Study Completion
December 1, 2011
Last Updated
April 20, 2017
Record last verified: 2017-04