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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02516449
Enrollment
51
Registered
2015-08-06
Start date
2013-03-31
Completion date
2013-11-30
Last updated
2015-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

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?

Sponsors

Chaire en transfert de connaissances, éducation et prévention en santé respiratoire et cardiovasculaire de l'Université Laval
CollaboratorUNKNOWN
Chaire sur l'adhésion aux traitements de l'Université Laval
CollaboratorUNKNOWN
Chaire de recherche du Canada en implantation de la prise de décision partagée dans les soins primaires de l'Université Laval
CollaboratorUNKNOWN
Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change from baseline in asthma knowledge at 2 months, measured by QCALF scoreVisit 1 (baseline) and visit 2 (2-month follow-up)
Change from baseline in decisional conflict at 2 months, measured by DCS scoreVisit 1 (baseline) and visit 2 (2-month follow-up)

Secondary

MeasureTime frame
Change from baseline in adherence to treatment at 2 months, measured by questionnaireVisit 1 (baseline) and visit 2 (2-month follow-up)
Change from baseline in asthma control at 2 months, measured by ACSS scoreVisit 1 (baseline) and visit 2 (2-month follow-up)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026