Randomised Controlled Trial of a Multi-faceted Community-based Intervention to Improve Asthma in Children
| Tracking Information | |||||
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| First Received Date ICMJE | October 12, 2005 | ||||
| Last Updated Date | November 26, 2010 | ||||
| Start Date ICMJE | August 2002 | ||||
| Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
rate of ED visits per person-month of observation, derived from Quebec provincial database (RAMQ) data. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00238888 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomised Controlled Trial of a Multi-faceted Community-based Intervention to Improve Asthma in Children | ||||
| Official Title ICMJE | 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) | ||||
| 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. |
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| 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 Centre d'Enseignement sur l'Asthme du Québec (CEA), and the treatment organigram 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 Centre d'Enseignement sur l'Asthme du Québec, 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 CEA 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Procedure: Repeated assessments of the child's asthma control using the Asthma Quiz for Kidz, with recommendation for asthma education and medical visit | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 298 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00238888 | ||||
| Other Study ID Numbers ICMJE | 015117 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | McGill University Health Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | McGill University Health Center | ||||
| Verification Date | November 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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