Assessment of Shared Decision Making Aids in Asthma

NCT ID: NCT02516449

Last Updated: 2015-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-11-30

Brief Summary

The purpose of this study is to determine whether the use of shared decision making aids is more effective than usual care in improving asthma knowledge, lessening decisional conflict, and enhancing adherence to treatments and asthma control in adult patients with mild to severe asthma.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Patient decision aids

Participants read and fill a patient decision aid before being provided education on asthma.

Group Type: EXPERIMENTAL

Patient decision aid

Intervention Type: OTHER

The patient decision aid is a 12-page A3 size color-printed booklet entitled "Should I take asthma inhaled controller medication to optimize asthma control?"

Usual care

Participants do not read and fill a patient decision aid before being provided education on asthma.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient decision aid

The patient decision aid is a 12-page A3 size color-printed booklet entitled "Should I take asthma inhaled controller medication to optimize asthma control?"

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Men or women, aged 18 to 65 years;

2. Current diagnosis of mild to severe asthma; 2.1) Asthma diagnosis will be made upon one of the following criteria: 2.1.1) Forced expiratory volume in one second (FEV1) increases by at least 12% after the use of a bronchodilator (and a minimum ≥ 200 mL); 2.1.2) Current asthma symptoms and a positive methacholine challenge test (20% fall in FEV1 after inhalation of a provocative dose of methacholine 16 mg/mL); 2.1.3) A respirologist's current diagnosis of asthma found in the patient's medical report. 2.2) Severity of asthma will be assessed according to prescribed pharmacotherapy, as suggested by the 2012 Canadian Thoracic Society Guidelines: 2.2.1) Patients with mild asthma using SABA as well as low doses (≤250 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids; 2.2.2) Patients with moderate asthma using SABA as well as low to moderate doses (250mcg/day < dose ≤500 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids, with or without additional therapy (LABA or LTRA); 2.2.3) Patients with severe asthma using high doses (>500 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids, and additional pharmacotherapy (LABA, LTRA, or Prednisone), and SABA.

Exclusion Criteria

1. Chronic obstructive pulmonary disease (COPD);

2. Education on asthma in the last 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chaire en transfert de connaissances, éducation et prévention en santé respiratoire et cardiovasculaire de l'Université Laval

UNKNOWN

Sponsor Role: collaborator

Chaire sur l'adhésion aux traitements de l'Université Laval

UNKNOWN

Sponsor Role: collaborator

Chaire de recherche du Canada en implantation de la prise de décision partagée dans les soins primaires de l'Université Laval

UNKNOWN

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Louis-Philippe Boulet

MD FRCPC FCCP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis-Philippe Boulet, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec

Locations

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

CER 20858

Identifier Type: -

Identifier Source: org_study_id