- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02093013
Effectiveness of an Integrated Care Program on Asthma Control and Inhaled Corticosteroids Adherence (RESPIRE)
Impact of an Integrated Care Intervention Program on Asthmatic Patients.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1S 4L8
- Centre hospitalier affilié universitaire de Québec
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Pregnancy, no prior asthma diagnosis, participation in an ongoing respiratory study, or another respiratory illness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Integrated care program
|
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.
|
No Intervention: Control group
This group kept receiving usual care from their health care professionals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma control
Time Frame: One year
|
The primary outcome was asthma control, measured with the validated Asthma Control Questionnaire.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to ICS
Time Frame: One year
|
Adherence to medication for each participant reporting an inhaled corticosteroids (ICS) prescription was assessed using two measures; the validated Morisky medication adherence scale (MMAS-4) composed of 4 questions (yes/no) about past medication use patterns, and the medication possession ratio (MPR), a validated objective measure based on pharmacy records.
|
One year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Implementation of the program
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jocelyne Moisan, Ph.D., URESP, Centre hospitalier affilié universitaire de Québec
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DR-002-1077
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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