Assessment of Shared Decision Making Aids in Asthma

NCT02516449 | Completed

• 1 other identifier: CER 20858
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

Study Arms (2)

Patient decision aids

EXPERIMENTAL

Participants read and fill a patient decision aid before being provided education on asthma.

Other: Patient decision aid

Usual care

NO INTERVENTION

Participants do not read and fill a patient decision aid before being provided education on asthma.

Interventions

Patient decision aid OTHER

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?"

Patient decision aids

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women, aged 18 to 65 years;
• 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.

You may not qualify if:

• Chronic obstructive pulmonary disease (COPD);
• Education on asthma in the last 6 months.

Sponsors & Collaborators

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

Study Sites (1)

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Louis-Philippe Boulet, MD

  Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FRCPC FCCP

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: August 6, 2015
• Study Start: March 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

CA (1)