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

This study has been completed.
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
GlaxoSmithKline
Information provided by (Responsible Party):
Francine Ducharme, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00238888
First received: October 12, 2005
Last updated: April 18, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Asthma Procedure: asthma control awareness Procedure: Usual care Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Other
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)

Further study details as provided by Francine Ducharme, McGill University Health Center:

Primary Outcome Measures:
  • rate of emergency department (ED) visits per person-month of observation, derived from Quebec provincial database (RAMQ) data. [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year after randomisation ]
    use of medication based on data claims from provincial administrative databases

  • Quality of life of the child and caregivers using Juniper's instruments [ Time Frame: 1 year after randomisation ]
    QOL measured on the Juniper questionnaires, measured at 12 months.

  • Change in asthma control between baseline and 12 months [ Time Frame: 1 year after randomisation ]
    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). [ Time Frame: 1 year after randomisation ]
    Use of healthcare services based on data claims from provincial administrative databases


Enrollment: 298
Study Start Date: August 2002
Study Completion Date: December 2011
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asthma control awareness
Multifaceted intervention to increase the patient awareness of the leve of asthma control
Procedure: asthma control awareness
Repeated assessments of the child's asthma control using the Asthma Quiz for Kidz, with recommendation for asthma education and medical visit
Active Comparator: Usual care
Usual care
Procedure: Usual care
Recommendation for asthma education and/or follow-up at the physician's discretion

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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  1. the index exacerbation is the first episode of wheezing in the previous year,
  2. there is co-existence of other chronic pulmonary (such as Bronchopulmonary dysplasia (BPD), cystic fibrosis (CF)), renal or cardiac diseases;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238888

Locations
Canada, Quebec
Ste-Justine Hospital
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
McGill University Health Center
Fonds de la Recherche en Santé du Québec
GlaxoSmithKline
Investigators
Principal Investigator: Francine M. Ducharme, MD, MSc CHUS-Ste Justine Hospital
  More Information

Responsible Party: Francine Ducharme, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00238888     History of Changes
Other Study ID Numbers: 015117
Study First Received: October 12, 2005
Last Updated: April 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Francine Ducharme, McGill University Health Center:
asthma
children
adolescent
education
medical review
asthma control
questionnaire
quality of life
emergency department visit
use of medication
adherence to treatment

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2017