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AsthmaPhase 4NCT00238888

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

A Phase 4 study of Asthma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Asthma
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
1 siteCanada
Study dates
Aug 2002to Dec 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children between 6 and 17 years of
  • acute asthma requiring emergency room visit or hospital admission
  • understanding of French or English

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Ste-Justine Hospital

    Montreal, Quebec, H3T 1C5

Other trials in Canada

About this study

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)

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.

Read the 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.

Conditions
Asthma
Being tested
asthma control awareness, Usual care
Keywords
asthma, children, adolescent, education, medical review, asthma control, questionnaire, quality of life, emergency department visit, use of medication, adherence to treatment
Medical subject headings
Asthma, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • asthma control awarenessProcedure or surgery

    Repeated assessments of the child's asthma control using the Asthma Quiz for Kidz, with recommendation for asthma education and medical visit

  • Usual careProcedure or surgery

    Recommendation for asthma education and/or follow-up at the physician's discretion

Study groups in NCT00238888
Study groupRoleWhat they receive
Asthma control awarenessExperimentalMultifaceted intervention to increase the patient awareness of the leve of asthma control
Receives: Procedure: asthma control awareness
Usual careActive comparatorUsual care
Receives: Procedure: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (4)
  1. 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

    Measured: 1 year after randomisation

  2. Quality of life of the child and caregivers using Juniper's instruments

    QOL measured on the Juniper questionnaires, measured at 12 months.

    Measured: 1 year after randomisation

  3. Change in asthma control between baseline and 12 months

    Change in Asthma Quiz for Kidz score between baseline and 12 months

    Measured: 1 year after randomisation

  4. 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

    Measured: 1 year after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2005 (estimated)
  2. Study startAug 2002
  3. Primary completionApr 2007
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00238888
Sponsor's protocol ID
015117
Status last verified
Apr 2017
First submitted
12 Oct 2005
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Asthma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of emergency department (ED) visits per person-month of observation, derived from Quebec provincial database (RAMQ) data. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.

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