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Completed

NCT Number: NCT02093013

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

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).

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Key information

Conditions

Asthma Behavior Bronchial Diseases Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Medication Adherence Patient Acceptance of Health Care Patient Compliance Respiratory Hypersensitivity Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier affilié universitaire de Québec

Québec, Quebec, G1S 4L8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrated care program

Other

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 outcomes

  1. Asthma control

    Time frame: One year

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

Secondary outcomes

  1. 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.

Other outcomes

  1. Implementation of the program

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Fonds de la Recherche en Santé du Québec

Registry information

Official study title

Impact of an Integrated Care Intervention Program on Asthmatic Patients.

Acronym: RESPIRE

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Mar 20, 2014
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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