NCT02093013

Brief Summary

The investigators propose to implement and evaluate an integrated care program for enhancing the care of patients with asthma in a region of Quebec province, Canada. The investigators will implement our intervention in a family medicine group practice setting and plan to deliver it to 150 experimental group subjects. The investigators will simultaneously study 300 control subjects who are receiving usual care in other regions of the province of Quebec. Our hypothesis is that the program will improve the quality of life of patients with asthma exposed to the program, asthma control, inhaled corticosteroid adherence, knowledge of asthma, and a number of variables that relate to the conceptual model selected as a framework for this study (the PRECEDE-PROCEED model of Green and Kreuter).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
349

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started May 2004

Typical duration for not_applicable 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

Study Start

First participant enrolled

May 1, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

2.7 years

First QC Date

March 18, 2014

Last Update Submit

March 28, 2017

Conditions

Asthma

Keywords

asthmainterventionmedication adherenceinhaled corticosteroidsasthma controlintegrated care

Outcome Measures

Primary Outcomes (1)

  • Asthma control

    The primary outcome was asthma control, measured with the validated Asthma Control Questionnaire.

    One year

Secondary Outcomes (1)

  • Adherence to ICS

    One year

Other Outcomes (1)

  • Implementation of the program

    One year

Study Arms (2)

Integrated care program

EXPERIMENTAL
Other: Integrated care program

Control group

NO INTERVENTION

This group kept receiving usual care from their health care professionals.

Interventions

Integrated care programOTHER

Integrated care program meant in effect, calling on the family medicine group (FMG) nurses to evaluate and support asthmatic patients. The FMG and asthma education centre (AEC) nurses received special training and followed a protocol based on the theoretical model and the Canadian asthma management recommendations then in force. The protocol had five main aspects: 1) asthma assessment, 2) self-management, 3) environment and lifestyle, 4) collaborative care plan, and 5) information sharing and follow-up.

Integrated care program

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Individuals aged 12 to 45 years, for whom the pharmacists had dispensed at least one anti-asthma drug in the previous six months were screened and randomly contacted by phone. Those who reported an asthma diagnosis and who were using a short-acting beta-2-agonist (SABA) \>3 times a week (except before exercise) or a corticosteroid (inhaled or oral), irrespective of frequency were included.

You may not qualify if:

  • Pregnancy, no prior asthma diagnosis, participation in an ongoing respiratory study, or another respiratory illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier affilié universitaire de Québec

Québec, Quebec, G1S 4L8, Canada

Location

Related Publications (3)

  • Jobin MS, Moisan J, Bolduc Y, Dorval E, Boulet LP, Gregoire JP. Factors associated with the appropriate use of asthma drugs. Can Respir J. 2011 Mar-Apr;18(2):97-104. doi: 10.1155/2011/426528.

    PMID: 21499595RESULT

  • Guenette L, Breton MC, Gregoire JP, Jobin MS, Bolduc Y, Boulet LP, Dorval E, Moisan J. Effectiveness of an asthma integrated care program on asthma control and adherence to inhaled corticosteroids. J Asthma. 2015;52(6):638-45. doi: 10.3109/02770903.2014.999084.

    PMID: 25539138RESULT

  • Adouni Lawani M, Zongo F, Breton MC, Moisan J, Gregoire JP, Dorval E, Boulet LP, Jobin MS, Guenette L. Factors associated with adherence to asthma treatment with inhaled corticosteroids: A cross-sectional exploratory study. J Asthma. 2018 Mar;55(3):318-329. doi: 10.1080/02770903.2017.1326131. Epub 2017 May 26.

    PMID: 28471286DERIVED

MeSH Terms

Conditions

AsthmaMedication Adherence

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jocelyne Moisan, Ph.D.

    URESP, Centre hospitalier affilié universitaire de Québec

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 20, 2014

Study Start

May 1, 2004

Primary Completion

January 1, 2007

Study Completion

July 1, 2007

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

CA(1)