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

Asthma Clinical Trial

— RESPIRE  

Official title:

Impact of an Integrated Care Intervention Program on Asthmatic Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093013
• Other study ID #: DR-002-1077
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: March 28, 2017
• Start date: May 2004
• Est. completion date: July 2007

Study information

• Verified date: March 2017
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: July 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Centre hospitalier affilié universitaire de Québec	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Guénette L, Breton MC, Grégoire 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: 10.3109/02770903.2014.9 — View Citation

Jobin MS, Moisan J, Bolduc Y, Dorval E, Boulet LP, Grégoire JP. Factors associated with the appropriate use of asthma drugs. Can Respir J. 2011 Mar-Apr;18(2):97-104. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation of the program		One year
Primary	Asthma control	The primary outcome was asthma control, measured with the validated Asthma Control Questionnaire.	One year
Secondary	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.	One year