Assessment of Shared Decision Making Aids in Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Patient decision aid

• Registration Number: NCT02516449
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2015-07-02
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-03
• Last Update Submitted: 2015-08-03
• Study First Posted: 2015-08-06
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient decision aids	Patient decision aid	Participants read and fill a patient decision aid before being provided education on asthma.

Primary Outcome Measures

Name	Time	Method
Change from baseline in asthma knowledge at 2 months, measured by QCALF score	Visit 1 (baseline) and visit 2 (2-month follow-up)
Change from baseline in decisional conflict at 2 months, measured by DCS score	Visit 1 (baseline) and visit 2 (2-month follow-up)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in adherence to treatment at 2 months, measured by questionnaire	Visit 1 (baseline) and visit 2 (2-month follow-up)
Change from baseline in asthma control at 2 months, measured by ACSS score	Visit 1 (baseline) and visit 2 (2-month follow-up)

Trial Locations

Locations (1)

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Québec, Quebec, Canada