Assessment of Shared Decision Making Aids in Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516449
• Other study ID #: CER 20858
• Status: Completed
• Phase: N/A
• First received: July 2, 2015
• Last updated: August 3, 2015
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: August 2015
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

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?"

Locations

Country	Name	City	State
Canada	Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec	Québec	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Laval University	Chaire de recherche du Canada en implantation de la prise de décision partagée dans les soins primaires de l'Université Laval, 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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in asthma knowledge at 2 months, measured by QCALF score		Visit 1 (baseline) and visit 2 (2-month follow-up)	No
Primary	Change from baseline in decisional conflict at 2 months, measured by DCS score		Visit 1 (baseline) and visit 2 (2-month follow-up)	No
Secondary	Change from baseline in adherence to treatment at 2 months, measured by questionnaire		Visit 1 (baseline) and visit 2 (2-month follow-up)	No
Secondary	Change from baseline in asthma control at 2 months, measured by ACSS score		Visit 1 (baseline) and visit 2 (2-month follow-up)	No