Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381355
Status:
COMPLETED
Last Update Posted:
2014-03-27
First Post:
2006-09-25
Brief Title:
RCT of a Written Action Plan vs Usual Care in Children With Acute Asthma
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Does the Use of a New Written Action Plan Increase Short-term Adherence to Prescribed Medication and Asthma Control in Children Treated for an Asthma Attack in the Emergency Department A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the proposed large high-intensity randomised controlled trial is to evaluate the real-life effectiveness of providing a written action plan to asthmatic children discharged from the emergency department ED or hospital on the short-term adherence to written recommendations including medication attendance to asthma education and medical follow-up main outcome is adherence to prescribed inhaled preventive medication measured by an electronic counter Secondary outcomes include attendance to asthma education and to medical follow-up serving by pharmacy of prescription of oral steroids as well as asthma control measured by questionnaire Asthma Quiz for Kidz2 use of rescue ß2-agonists relapse to emergency room
Detailed Description:
The objective of the proposed large high-intensity randomised controlled trial is to evaluate the real-life effectiveness of providing a written action plan to asthmatic children discharged from the emergency department ED or hospital on the short-term adherence to written recommendations including medication attendance to asthma education and medical follow-up Contrary to the traditional definition of a written action plan1 ie a set of written instructions to follow in case of an exacerbation we propose to test a new written action plan based on the innovative concept that emphasises the key elements associated with good asthma care 1 use of preventive medication 2 need for asthma education 3 need for regular medical review 4 environmental control and 5 instructions for use of rescue medication The main outcome is adherence to prescribed inhaled preventive medication measured by an electronic counter Secondary outcomes include attendance to asthma education and to medical follow-up serving by pharmacy of prescription of oral steroids as well as asthma control measured by questionnaire Asthma Quiz for Kidz2 use of rescue ß2-agonists relapse to emergency room Because of the recommended medical follow-up where primary care physicians may recommend a change in the preventive treatment initiated in hospital only short-term outcomes occurring within 28 days of the index visit will be considered as associated with the use of the written action plan We have purposely designed this trial to test the additional benefit of the intervention over the usual care recognizing the heterogeneity in the amount of asthma information provided within the time constraints of the emergency room by our 90 physicians To provide clinically meaningful and generalisable information the eligibility criteria for study entry have been limited to the bare necessity to confirm the diagnosis of asthma The randomisation will be stratified on age to reflect the target interlocutor of the written action plan namely the parents for the 60 children aged 6 years the child and parent pair for the 40 children aged 7 to 12 years old and the adolescents for the 10 patients aged 13-17 years old We anticipate important variations in the characteristics of enrolled patients reflecting the real heterogeneity of the emergency department attendees namely in the severity of baseline exacerbation 55 mild 35 moderate 10 severe ownership of a written action plan 15 prior asthma education 30 use of daily preventive medicine 25 etc all of which may influence the adherence rate to the written action plan To compensate this heterogeneity in patients characteristics and provided instructions the power of the trial to identify a clinically important difference in the main outcome has been set at 90 rather than the traditional 80 The strength of the proposed study is clearly the assessment the real-life effectiveness of providing a new concept written action plan to a high-risk population to improve the main obstacles to good asthma control namely adherence to preventive medication and attendance to asthma education and regular review
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None