DeliriumNCT02978352
A Comparison of Learning Method (CAM-ICU) Between E-learning and Conventional Face-to-face Lecture and Demonstration
A study testing learning in people with Delirium, run by Mahidol University.
Trial summary
Delirium is an acute and fluctuating disturbance of consciousness characterized by reduced attention, impaired cognition and perception, usually resulting from general physical conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ICU nurse
- general ward nurse
- private ward nurses
- nurse anesthetists
Who cannot join
- Previous exposure to CAM-ICU
- Inability to complete the training courses
- Inability to complete the required 3 simulated patient scenarios
About this study
Official title: A Comparison of Learning Effectiveness of Confusion Assessment Method (CAM-ICU) Between E-learning and Conventional Face-to-face Lecture and Demonstration
Delirium is an acute and fluctuating disturbance of consciousness characterized by reduced attention, impaired cognition and perception, usually resulting from general physical conditions. Delirium contributes to longer hospital length of stay, increased mortality, increased healthcare costs, and long-term cognitive and functional impairment. However, it is often underdiagnosed and undertreated. E-learning (electronic learning) proves to be a time-efficient, flexible and convenient training method, making it suitable for a large organization like Siriraj hospital where there is a large employee turnover rate. So the investigators want to compare the passing rate between the e-learning group and the traditional learning group.
Read the detailed description
Primary objective: Compare the passing rate between the e-learning group and the traditional learning group
Secondary objectives: Assess the trainees' satisfaction and problems associated with e-learning implementation, Investigate the causes of inaccurate CAM-ICU assessment for improvement in future training sessions
- Conditions
- Delirium
- Being tested
- learning
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
learningOther
| Study group | Role | What they receive |
|---|---|---|
| face-to-face | Experimental | Traditional learning group (face-to-face): 4 different sessions will be conducted to suit the participants' convenience Duration of each session is 60-90 minutes Each session comprises lecture, video demonstration of CAM-ICU assessment, discussion, volunteer participation during class demonstration Receives: Other: learning |
| E-learning | Experimental | 60-90 minute online course will be accessible through intranet Wi-Fi The course encompasses types, incidence, risk factors, significance and effects of delirium, diagnostic criteria and CAM-ICU application Inclusion of video demonstration of simulated patients and CAM-ICU application, common pitfalls of healthcare providers, and practice questions Receives: Other: learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The passing rate between the e-learning group and the traditional learning group
Measured: 2 weeks
Secondary outcomes (2)
Assess the trainees' satisfaction
Satisfaction score from 0 (dissatisfy) and 10 (very satisfy)
Measured: 2 weeks
Investigate the causes of inaccurate CAM-ICU assessment for improvement in future training sessions
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978352
- Sponsor's protocol ID
- 300/2559(EC4)
- Status last verified
- Jun 2017
- First submitted
- 21 Nov 2016
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Learning Effectiveness of Confusion Assessment Method (CAM-ICU) Between E-learning and Conventional Face-to-face Lecture and Demonstration
- ClinicalTrials.gov ID
- NCT02978352
- Acronym / sponsor ID
- 300/2559(EC4)
- Conditions
- Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Nov 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.
Delirium is an acute and fluctuating disturbance of consciousness characterized by reduced attention, impaired cognition and perception, usually resulting from general physical conditions. Delirium contributes to longer hospital length of stay, increased mortality, increased healthcare costs, and long-term cognitive and functional impairment. However, it is often underdiagnosed and undertreated. E-learning (electronic learning) proves to be a time-efficient, flexible and convenient training method, making it suitable for a large organization like Siriraj hospital where there is a large employee turnover rate. So the investigators want to compare the passing rate between the e-learning group and the traditional learning group.
Detailed description
Primary objective: Compare the passing rate between the e-learning group and the traditional learning group
Secondary objectives: Assess the trainees' satisfaction and problems associated with e-learning implementation, Investigate the causes of inaccurate CAM-ICU assessment for improvement in future training sessions
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| face-to-face | Experimental | Other: learningTraditional learning group (face-to-face): 4 different sessions will be conducted to suit the participants' convenience Duration of each session is 60-90 minutes Each session comprises lecture, video demonstration of CAM-ICU assessment, discussion, volunteer participation during class demonstration |
| E-learning | Experimental | Other: learning60-90 minute online course will be accessible through intranet Wi-Fi The course encompasses types, incidence, risk factors, significance and effects of delirium, diagnostic criteria and CAM-ICU application Inclusion of video demonstration of simulated patients and CAM-ICU application, common pitfalls of healthcare providers, and practice questions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICU nurse
- general ward nurse
- private ward nurses
- nurse anesthetists
Key exclusion criteria (3 listed)
- Previous exposure to CAM-ICU
- Inability to complete the training courses
- Inability to complete the required 3 simulated patient scenarios
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 |
|---|---|---|
| learning | Other | E-learning, face-to-face |
Primary outcome
The passing rate between the e-learning group and the traditional learning group
Time frame: 2 weeks
2 secondary outcomes
Assess the trainees' satisfaction
Time frame: 2 weeks
Investigate the causes of inaccurate CAM-ICU assessment for improvement in future training sessions
Time frame: 2 weeks
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 26 Jun 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing learning in people with Delirium, run by Mahidol University.
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 4 inclusion and 3 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 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The passing rate between the e-learning group and the traditional learning group (time frame: 2 weeks). 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 26 Jun 2017.