AsthmaNCT01520883
Evaluation of Decisional Conflict and Needs Assessment in Asthma Management
An observational study of Asthma, run by Laval University at 1 site in Canada.
Trial summary
Many patients suffering from asthma are not compliant to their treatment and consequently, are not well controlled. Shared decision making intervention has shown an improvement in the outcome of patients with chronic disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with mild to moderate asthma controlled or slightly controlled
Who may be able to join
- 18-65 years
- diagnosed asthma
Who cannot join
- received asthma education in the past 2 years
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Official title: Decisional Conflict and Needs Assessment in Shared Decision Making in Asthma Management
Many patients suffering from asthma are not compliant to their treatment and consequently, are not well controlled. Shared decision making intervention has shown an improvement in the outcome of patients with chronic disease. The aim of this study is to evaluate decisional conflict and to assess decisional needs of adults with asthma.
Read the detailed description
Asthmatic patients will be recruited and asked to fill a decisional conflict scale.
Patients, asthma educators and physicians will also be recruited to fill a needs assessment questionnaire about decisions taken by asthmatics.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DEcisional conflict | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Decisional Conflict with a valid Decisional Conflict Scale
To measure the level of decisional conflict, subjects were asked to fill out a decisional conflict scale on asthma management which was developed by O'Connor adapted for our study. This questionnaire consisted of 16 questions. The answers used a Likert scale ranged from 1 - strongly agree to 5 - strongly disagree.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, AllerGen NCE Inc.
- Responsible party
- Principal investigator, Louis-Philippe Boulet, Laval University
- Investigators
- Louis-Philippe Boulet, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520883
- Sponsor's protocol ID
- CER 20646
- Status last verified
- May 2013
- First submitted
- 4 Oct 2011
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decisional Conflict and Needs Assessment in Shared Decision Making in Asthma Management
- ClinicalTrials.gov ID
- NCT01520883
- Acronym / sponsor ID
- CER 20646
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, AllerGen NCE Inc.
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many patients suffering from asthma are not compliant to their treatment and consequently, are not well controlled. Shared decision making intervention has shown an improvement in the outcome of patients with chronic disease. The aim of this study is to evaluate decisional conflict and to assess decisional needs of adults with asthma.
Detailed description
Asthmatic patients will be recruited and asked to fill a decisional conflict scale.
Patients, asthma educators and physicians will also be recruited to fill a needs assessment questionnaire about decisions taken by asthmatics.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEcisional conflict | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with mild to moderate asthma controlled or slightly controlled
Key inclusion criteria (2 listed)
- 18-65 years
- diagnosed asthma
Key exclusion criteria (1 listed)
- received asthma education in the past 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring Decisional Conflict with a valid Decisional Conflict Scale
Time frame: 6 month
To measure the level of decisional conflict, subjects were asked to fill out a decisional conflict scale on asthma management which was developed by O'Connor adapted for our study. This questionnaire consisted of 16 questions. The answers used a Likert scale ranged from 1 - strongly agree to 5 - strongly disagree.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis-Philippe Boulet, MD principal investigator
Institut universitaire de cardiologie et de pneumologie de Quebec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Decisional Conflict with a valid Decisional Conflict Scale (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.