Assessment of Shared Decision Making Aids in Asthma

Utility of Two Patients Decision Aids About Asthma Inhaled Controller Medication Use in Adult Patients With Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Patient decision aid

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient decision aids; Participants read and fill a patient decision aid before being provided education on asthma.	Other: 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?"
No Intervention: Usual care; Participants do not read and fill a patient decision aid before being provided education on asthma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Chaire en transfert de connaissances, éducation et prévention en santé respiratoire et cardiovasculaire de l'Université Laval; Chaire sur l'adhésion aux traitements de l'Université Laval; Chaire de recherche du Canada en implantation de la prise de décision partagée dans les soins primaires de l'Université Laval
• Investigators: Principal Investigator: Louis-Philippe Boulet, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (Estimate): August 6, 2015

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CER 20858