Clinical trial NCT02516449: Assessment of Shared Decision Making Aids in Asthma
Official title: Utility of Two Patients Decision Aids About Asthma Inhaled Controller Medication Use in Adult Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Chaire en transfert de connaissances, éducation et prévention en santé respiratoire et cardiovasculaire de l'Université Laval
name: Chaire sur l'adhésion aux traitements de l'Université Laval
name: Chaire de recherche du Canada en implantation de la prise de décision partagée dans les soins primaires de l'Université Laval
First posted: 2015-08-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Change from baseline in asthma knowledge at 2 months, measured by QCALF score
timeFrame: Visit 1 (baseline) and visit 2 (2-month follow-up)
measure: Change from baseline in decisional conflict at 2 months, measured by DCS score
timeFrame: Visit 1 (baseline) and visit 2 (2-month follow-up)
Secondary outcomes:
measure: Change from baseline in adherence to treatment at 2 months, measured by questionnaire
timeFrame: Visit 1 (baseline) and visit 2 (2-month follow-up)
measure: Change from baseline in asthma control at 2 months, measured by ACSS score
timeFrame: Visit 1 (baseline) and visit 2 (2-month follow-up)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
name: Louis-Philippe Boulet, MD
role: PRINCIPAL_INVESTIGATOR
References: