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OpenTrials
Completed

NCT Number: NCT02516449

Assessment of Shared Decision Making Aids in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, Quebec, G1V 4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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?"

Primary outcomes

  1. Change from baseline in asthma knowledge at 2 months, measured by QCALF score

    Time frame: Visit 1 (baseline) and visit 2 (2-month follow-up)

  2. Change from baseline in decisional conflict at 2 months, measured by DCS score

    Time frame: Visit 1 (baseline) and visit 2 (2-month follow-up)

Secondary outcomes

  1. Change from baseline in adherence to treatment at 2 months, measured by questionnaire

    Time frame: Visit 1 (baseline) and visit 2 (2-month follow-up)

  2. Change from baseline in asthma control at 2 months, measured by ACSS score

    Time frame: Visit 1 (baseline) and visit 2 (2-month follow-up)

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 6, 2015
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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