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Effectiveness of an Integrated Care Program on Asthma Control and Inhaled Corticosteroids Adherence (RESPIRE)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Integrated care program
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring asthma, intervention, medication adherence, inhaled corticosteroids, asthma control, integrated care

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre hospitalier affilié universitaire de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrated care program

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adherence to ICS
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.

Full Information

First Posted
March 18, 2014
Last Updated
March 28, 2017
Sponsor
Laval University
Collaborators
Fonds de la Recherche en Santé du Québec
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1. Study Identification

Unique Protocol Identification Number
NCT02093013
Brief Title
Effectiveness of an Integrated Care Program on Asthma Control and Inhaled Corticosteroids Adherence
Acronym
RESPIRE
Official Title
Impact of an Integrated Care Intervention Program on Asthmatic Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Fonds de la Recherche en Santé du Québec

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, intervention, medication adherence, inhaled corticosteroids, asthma control, integrated care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
349 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated care program
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group kept receiving usual care from their health care professionals.
Intervention Type
Other
Intervention Name(s)
Integrated care program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma control
Description
The primary outcome was asthma control, measured with the validated Asthma Control Questionnaire.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Adherence to ICS
Description
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.
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Implementation of the program
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyne Moisan, Ph.D.
Organizational Affiliation
URESP, Centre hospitalier affilié universitaire de Québec
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier affilié universitaire de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21499595
Citation
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.
Results Reference
result
PubMed Identifier
25539138
Citation
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.
Results Reference
result
PubMed Identifier
28471286
Citation
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.
Results Reference
derived

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Effectiveness of an Integrated Care Program on Asthma Control and Inhaled Corticosteroids Adherence

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