Lung Diseases, ObstructiveNCT02870998
Impacts of a Continuing Education Activity Targeted at COPD Case Managers
A study testing Active learning and Passive learning in people with Lung Diseases, Obstructive, run by Laval University at 1 site in Canada.
Trial summary
This study aims to compare the impacts of two versions of a continuing education activity targeted at COPD case managers on educational outcomes: 1) participation; 2) satisfaction; 3) learning; 4) competence; 5) performance; 6) patient health outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases, Obstructive
- What is being tested?
- Active learning and Passive learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Nov 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Attending the continuing education activity
- Providing patient education to individuals with COPD in professional setting.
- Doctor-diagnosed COPD.
Who cannot join
- None
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
Myriam Gagné, MSc, 4186568711 ext. 2714, myriam.gagne@criucpq.ulaval.ca
About this study
Official title: Comparing the Impacts of Two Versions of a Continuing Education Activity Targeted at COPD Case Managers on Educational Outcomes
This study aims to compare the impacts of two versions of a continuing education activity targeted at COPD case managers on educational outcomes: 1) participation; 2) satisfaction; 3) learning; 4) competence; 5) performance; 6) patient health outcomes.
Read the detailed description
This study has a quasi-experimental design. The study is based on the Expanded Outcomes Framework for Planning and Assessing Continung Medical Education by Moore (2009). One groupe of participants will attend the former version of the continuing education activity, and the other group will attend its new version.
Data will be collected at T0 (before the activity, which will be held at T1); at T2 (immediately after the activity); at T3 (1-month post-activity); at T4 (2-month post-activity); at T5 (4-month post-activity); at T6 (10-month post-activity).
Participation will be assessed at T0. Satisfaction will be assessed at T2. Learning will be assessed at T0 and T3. Competence will be assessed at T2. Performance will be assessed at T4. Patient health outcomes will be assessed at T5 and T6.
- Conditions
- Lung Diseases, Obstructive
- Being tested
- Active learning, Passive learning
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active learningOther
1-day continuing education activity consisting of a lecture on patient education.
Passive learningOther
1-day continuing education activity consisting of a brief lecture on patient education and workshops.
| Study group | Role | What they receive |
|---|---|---|
| Active learning | Experimental | Educational strategies will be used to foster active learning. Receives: Other: Active learning |
| Passive learning | Active comparator | Traditional educational strategies (lecture) will be used. Receives: Other: Passive learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
We will videotape patient education intervention delivered by attendees in their professional practice and will assess the quality of the delivered patient education intervention using a set a pre-defined criteria.
Measured: 2-month post-intervention
Secondary outcomes (4)
Satisfaction
We will measured the extent to which attendees' expectations about the continuing education activity are met, using a self-administered questionnaire.
Measured: Immediately post-intervention
Learning
We will measured declarative and procedural knowledge about patient education in attendees, using a validated self-administered questionnaire.
Measured: Prior to and 1-month post-intervention
Competence
We will measure attendees' self-reported competences in achieving learning activity objectives, using a self-administered questionnaire.
Measured: Prior and immediately post-intervention
Patient health outcomes
We will measured COPD patients' health-related quality of life, self-management skills, and health utilization, using validated interviewer-administered questionnaires.
Measured: 4-month and 10-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis-Philippe Boulet, Laval University
- Investigators
- Louis-Philippe Boulet, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870998
- Sponsor's protocol ID
- MP-10-2016-2591
- Status last verified
- Feb 2019
- First submitted
- 15 Mar 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The datasets during and/or analysed during the current study will be available from the principal investigator on reasonable request.
Publications
Gagne M, Lauzier S, Babineau-Therrien J, Hamel C, Penney SE, Bourbeau J, Moisan J, Boulet LP. COPD-Specific Self-Management Support Provided by Trained Educators in Everyday Practice is Associated with Improved Quality of Life, Health-Directed Behaviors, and Skill and Technique Acquisition: A Convergent Embedded Mixed-Methods Study. Patient. 2020 Feb;13(1):103-119. doi: 10.1007/s40271-019-00386-7.
PubMed 31502238Gagne M, Moisan J, Lauzier S, Hamel C, Cote P, Bourbeau J, Boulet LP. Comparative impact of two continuing education activities targeted at COPD educators on educational outcomes: protocol for a non-randomized controlled study using mixed methods. BMC Health Serv Res. 2018 Jun 18;18(1):460. doi: 10.1186/s12913-018-3284-6.
PubMed 29914484
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Impacts of Two Versions of a Continuing Education Activity Targeted at COPD Case Managers on Educational Outcomes
- ClinicalTrials.gov ID
- NCT02870998
- Acronym / sponsor ID
- MP-10-2016-2591
- Conditions
- Lung Diseases, Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 18 Aug 2016 (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.
This study aims to compare the impacts of two versions of a continuing education activity targeted at COPD case managers on educational outcomes: 1) participation; 2) satisfaction; 3) learning; 4) competence; 5) performance; 6) patient health outcomes.
Detailed description
This study has a quasi-experimental design. The study is based on the Expanded Outcomes Framework for Planning and Assessing Continung Medical Education by Moore (2009). One groupe of participants will attend the former version of the continuing education activity, and the other group will attend its new version.
Data will be collected at T0 (before the activity, which will be held at T1); at T2 (immediately after the activity); at T3 (1-month post-activity); at T4 (2-month post-activity); at T5 (4-month post-activity); at T6 (10-month post-activity).
Participation will be assessed at T0. Satisfaction will be assessed at T2. Learning will be assessed at T0 and T3. Competence will be assessed at T2. Performance will be assessed at T4. Patient health outcomes will be assessed at T5 and T6.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active learning | Experimental | Other: Active learningEducational strategies will be used to foster active learning. |
| Passive learning | Active comparator | Other: Passive learningTraditional educational strategies (lecture) will be used. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Attending the continuing education activity
- Providing patient education to individuals with COPD in professional setting.
- Doctor-diagnosed COPD.
Key exclusion criteria (2 listed)
- None
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active learning1-day continuing education activity consisting of a lecture on patient education. | Other | Active learning |
| Passive learning1-day continuing education activity consisting of a brief lecture on patient education and workshops. | Other | Passive learning |
Primary outcome
Performance
Time frame: 2-month post-intervention
We will videotape patient education intervention delivered by attendees in their professional practice and will assess the quality of the delivered patient education intervention using a set a pre-defined criteria.
4 secondary outcomes
Satisfaction
Time frame: Immediately post-intervention
Learning
Time frame: Prior to and 1-month post-intervention
Competence
Time frame: Prior and immediately post-intervention
Patient health outcomes
Time frame: 4-month and 10-month post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 31502238Gagne M, Lauzier S, Babineau-Therrien J, Hamel C, Penney SE, Bourbeau J, Moisan J, Boulet LP. COPD-Specific Self-Management Support Provided by Trained Educators in Everyday Practice is Associated with Improved Quality of Life, Health-Directed Behaviors, and Skill and Technique Acquisition: A Convergent Embedded Mixed-Methods Study. Patient. 2020 Feb;13(1):103-119. doi: 10.1007/s40271-019-00386-7.
- Derived from this study: PubMed 29914484Gagne M, Moisan J, Lauzier S, Hamel C, Cote P, Bourbeau J, Boulet LP. Comparative impact of two continuing education activities targeted at COPD educators on educational outcomes: protocol for a non-randomized controlled study using mixed methods. BMC Health Serv Res. 2018 Jun 18;18(1):460. doi: 10.1186/s12913-018-3284-6.
- Individual participant dataSharing planned: Yes. The datasets during and/or analysed during the current study will be available from the principal investigator on reasonable request.
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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 Québec, University Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active learning and Passive learning in people with Lung Diseases, Obstructive, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myriam Gagne, MSc (1-418-656-8711 ext. 2714, myriam.gagne@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: 2-month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02870998, which also lists 2 linked publications.
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 Feb 2019.