NCT00381355

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 Kidz),2 use of rescue ß2-agonists, relapse to emergency room.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P50-P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

March 27, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

September 25, 2006

Last Update Submit

March 25, 2014

Conditions

Asthma

Keywords

asthmachildrenwritten action planeducationguided self-managementefficacycomplianceb2-agonistsinhaled corticosteroidsoral steroidsrelapserandomised controlled trialemergency department

Outcome Measures

Primary Outcomes (1)

  • Adherence rate to daily inhaled steroids, reported as the ratio of the sum of number of recorded over prescribed activation per day during the 28 days following the index visit.

Secondary Outcomes (8)

  • Proportion of children filling their prescription of oral steroids

  • Use of rescue B2-agonists measured by dose counter

  • Quality of life in children aged 7 years and older, measured by the Juniper Questionnaire

  • Quality of life of their parent, measured by the Juniper Questionnaire

  • Asthma control, measured by the Asthma Quiz for Kidz

  • +3 more secondary outcomes

Interventions

Written Action Plan for Acute AsthmaPROCEDURE

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children will be eligible, whether they are discharged from the ED or following a hospital admission, if:
  • aged 1 to 17 years;
  • presenting with acute asthma as per the 2003 Canadian Consensus Statement - The ED physician will be responsible for confirming the diagnosis of asthma;
  • requiring at least one nebulisation of salbutamol;
  • the ED physician plans on prescribing the patient inhaled steroids and/or inhaled b2-agonists delivered by metered dose inhaler or continuing a previously prescribed inhaled steroid;
  • the patient intends to stay in the Province of Quebec in the next 45 days;
  • the patient (and their parents) have a good understanding of written and spoken French or English.

You may not qualify if:

  • Children will be excluded if they:
  • currently take asthma medications (ß2-agonist and/or inhaled steroids) using a turbuhaler or diskus, because these delivery devices cannot be fitted with Doser CT, a computerized electronic dose counter for metered dose inhalers;
  • have another chronic lung disease (other than asthma) such as cystic fibrosis or bronchopulmonary dysplasia;
  • have known hypersensitivity to inhaled salbutamol or fluticasone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ste-Justine Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

  • Ducharme FM, Zemek RL, Chalut D, McGillivray D, Noya FJ, Resendes S, Khomenko L, Rouleau R, Zhang X. Written action plan in pediatric emergency room improves asthma prescribing, adherence, and control. Am J Respir Crit Care Med. 2011 Jan 15;183(2):195-203. doi: 10.1164/rccm.201001-0115OC. Epub 2010 Aug 27.

    PMID: 20802165DERIVED

MeSH Terms

Conditions

AsthmaPatient ComplianceRecurrenceEmergencies

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francine M. Ducharme, MD, MSc

    CHUS-Ste Justine Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 27, 2006

Study Start

October 1, 2006

Primary Completion

April 1, 2007

Last Updated

March 27, 2014

Record last verified: 2014-03

Locations

CA(1)