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Assessment of Shared Decision Making Aids in Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Patient decision aid

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient decision aids

Usual care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02516449

First Posted

July 2, 2015

Last Updated

August 3, 2015

Sponsor

Laval University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02516449

Brief Title

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

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patient decision aids

Arm Type

Experimental

Arm Description

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

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Patient decision aid

Intervention Description

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 Outcome Measure Information:

Title

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)

Title

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 Outcome Measure Information:

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis-Philippe Boulet, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

12. IPD Sharing Statement

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Assessment of Shared Decision Making Aids in Asthma

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