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Randomised Controlled Trial of a Multi-faceted Community-based Intervention to Improve Asthma in Children

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
asthma control awareness
Usual care
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring asthma, children, adolescent, education, medical review, asthma control, questionnaire, quality of life, emergency department visit, use of medication, adherence to treatment

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children between 6 and 17 years of acute asthma requiring emergency room visit or hospital admission understanding of French or English Exclusion Criteria: 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;

Sites / Locations

  • Ste-Justine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Asthma control awareness

Usual care

Arm Description

Multifaceted intervention to increase the patient awareness of the leve of asthma control

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
use of medication based on data claims from provincial administrative databases
Quality of life of the child and caregivers using Juniper's instruments
QOL measured on the Juniper questionnaires, measured at 12 months.
Change in asthma control between baseline and 12 months
Change in Asthma Quiz for Kidz score between baseline and 12 months
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).
Use of healthcare services based on data claims from provincial administrative databases

Full Information

First Posted
October 12, 2005
Last Updated
April 18, 2017
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Fonds de la Recherche en Santé du Québec, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00238888
Brief Title
Randomised Controlled Trial of a Multi-faceted Community-based Intervention to Improve Asthma in Children
Official Title
Randomised Controlled Trial of a Multi-faceted Community-based Intervention to Improve Pediatric Morbidity: a PRIISME Project (Program to Integrate Information Service and Manage Education)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Fonds de la Recherche en Santé du Québec, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In the philosophy of the "Programs to integrate information service and manage education(PRIISME)", the proposed randomised controlled trial will examine a novel approach based on education to trigger practice changes in community physicians and pharmacists as well as behavioural changes in parents of poorly controlled asthmatic children and in adolescents. Poorly controlled asthmatic children will be identified among those who present to the emergency department of the Montreal Children's Hospital for an acute asthma exacerbation. The novel approach hinges on alerting parents, physicians, pharmacists, and, for adolescents, the patients themselves, of the actual degree of asthma control and its impact on usual activities. The instrument used, the Asthma Quiz for Kidz, is a brief 5-item questionnaire based on the Canadian Asthma Consensus statement. The tested intervention is comprised of (1) notifying by mail the treating physician of: the index emergency department or hospital admission, the results on the Asthma Quiz for Kidz in the month preceding the index exacerbation, the orientation of the patient to his/her local Asthma Education Centre (AEC), and the treatment protocol of the Canadian Asthma Consensus statement and providing a prescription pad containing the Asthma Impact Checklist; (2) referring the parents and child or adolescent to a personalised educational session with a highly trained asthma educator approved by the AEC, at a site identified closest to home or work; giving them a refrigerator magnet of the Asthma Quiz for Kidz; trimestrial mailing the 5-item Asthma Quiz for Kidz with a simple guide to interpret the degree of control, re-enforcing the message that control can be improved, and reminding them to consult their physician; (3) providing the identified AEC educator with a standard form, to be mailed to the treating physician and the co-ordinating centre, on which to record the results on the Asthma Quiz for Kidz, the interventions and recommendations made to the parents pertaining to environment, drug use, need to consult MD for an action plan; (4) providing pharmacists with a pad of the Asthma Quiz for Kidz to administer to identified patients at each request to refill asthma drugs. The control intervention is the current usual care with referral of all hospitalised patients to the Montreal Children's Hospital (MCH) asthma educator (current attendance rate of 30%) and referral of non-hospitalised children to the MCH Asthma Centre, at the discretion of the emergency physicians. The primary outcome is the rate of emergency department visits in the 12 months post-randomisation. Secondary outcomes include others measures of health care resources utilisation (hospital admission, physician's visits), measures of appropriateness of asthma drug use (refill rate of reliever drugs, ratio of inhaled preventer/reliever drugs, rate of rescue systemic steroids), and quality of life measures (for the school-aged child and the caregiver). If proven effective in reducing asthma morbidity, the current strategy may be implemented at relatively low cost, relative to the savings in health care expenditures for poorly controlled asthmatic children. This intervention could then be tested in other populations and settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, children, adolescent, education, medical review, asthma control, questionnaire, quality of life, emergency department visit, use of medication, adherence to treatment

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthma control awareness
Arm Type
Experimental
Arm Description
Multifaceted intervention to increase the patient awareness of the leve of asthma control
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Procedure
Intervention Name(s)
asthma control awareness
Intervention Description
Repeated assessments of the child's asthma control using the Asthma Quiz for Kidz, with recommendation for asthma education and medical visit
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
Recommendation for asthma education and/or follow-up at the physician's discretion
Primary Outcome Measure Information:
Title
rate of emergency department (ED) visits per person-month of observation, derived from Quebec provincial database (RAMQ) data.
Description
rate of ED visit derived from provincial administrative databases
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Description
use of medication based on data claims from provincial administrative databases
Time Frame
1 year after randomisation
Title
Quality of life of the child and caregivers using Juniper's instruments
Description
QOL measured on the Juniper questionnaires, measured at 12 months.
Time Frame
1 year after randomisation
Title
Change in asthma control between baseline and 12 months
Description
Change in Asthma Quiz for Kidz score between baseline and 12 months
Time Frame
1 year after randomisation
Title
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).
Description
Use of healthcare services based on data claims from provincial administrative databases
Time Frame
1 year after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children between 6 and 17 years of acute asthma requiring emergency room visit or hospital admission understanding of French or English Exclusion Criteria: 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francine M. Ducharme, MD, MSc
Organizational Affiliation
CHUS-Ste Justine Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ste-Justine Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Randomised Controlled Trial of a Multi-faceted Community-based Intervention to Improve Asthma in Children

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