Learning DevelopmentCAINCT01627730
Computer-Assisted Instruction: Arterial Blood Gases
A study testing pretest and posttest scores in people with Learning Development, run by Mahidol University.
Trial summary
This research work develops a diagnostic and feedback-providing system for self-learning by volunteers who are asked to log in to a website to study the required subjects in three weeks. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Learning Development
- What is being tested?
- pretest and posttest scores
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Apr 2016
- 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
- 3rd year medical students
- Nurses in Critical care unit
Who cannot join
- non-volunteer
About this study
Official title: Development and Assessment of On-line Computer-Assisted Instruction: Arterial Blood Gases
This research work develops a diagnostic and feedback-providing system for self-learning by volunteers who are asked to log in to a website to study the required subjects in three weeks.
The system establishes students' learning weaknesses and offered guidelines for their improvement until all such weaknesses are corrected.
Assessment is based on students' relative growth scores, and their record profiles.
Read the detailed description
Website development: The www.nmac.in.th website contains the learning courseware database. The program is interactive, with personal files for each student along with other details like code, password, name, surname, date-month-year, test scores, and log-in periods and time.
Students can, on their own, plan their learning for each subject; they are free to record and copy the articles on the website. There is no log-in limit from any place with internet connection around the clock.
Learning courseware: We developed a set of learning courseware of the specified topics as activities and diagnostic tests for arterial blood gases (ABGs).
The activities covered topics under the table of specification, whereas the diagnostic tests probed the weaknesses of students' understanding of activities so as to assess their learning skills in analytical thinking of patients' problems under assorted circumstances to be faced in clinical practice.
Each set of courseware contained three levels: beginner, intermediate, and advanced.
Students are required to pass each in an orderly way, at least once with a minimum score of 80% before advancing to the next level.
Once they have passed certain courseware, they are free to review all learning courseware as often as they wanted to.
Learning sources: Interactive with students, the program identifies learning weaknesses while avoiding giving them direct answers immediately after each test.
What it does is instead to link the student to begin a search for the well-prepared content, which contains details of the subject.
Construction of test forms: Pre-test and post-test forms are designed to be parallel under the table of specification, thus preventing the carry-over effect by testing them three weeks afterward and alternating the questions or changing them.
The tests underwent verification for content validity and had their index of item objective congruence (IOC) determined by four clinical experts.
Deciding whether the tests and behavioral objectives aligned, they set the IOCs at 0.79 for pre-tests and 0.73 for post-tests.
- Two sets of pre-tests and post-tests of 10 questions each, with each question containing four sub-items requiring short answers
- 15 activities and 10 diagnostic tests of the multiple-choice (4) questions
System testing: We introduced the elements, namely the learning courseware, tests, and sources of learning, to the developed system before testing it under the research and development approach, the logical approach, and empirical approach.
Different sample sizes were used, and logical comments were analyzed to test the system efficiency under three stages:
First-stage system development and assessment:
- The sample group was 4 sixth year medical students who underwent system testing during a three-week period
- Objectives:
- To test system operating units and system log-ins
- To test the objectivity of the tools
- Findings:
- The system operating units were flexible to students' interactive behavior, instruction responsiveness, and network connection. Access to the system through the website provided ready access to the information, was user-friendly, and was stable.
- The tools were objective, covered complete details, and were clear, with elements of the subject content in proper order.
- Improvement:
- Making the system interactive with the network; focusing on conciseness; adding channels for answering questionnaires through the website; adding the record on downloading articles from the website; notifying students of their performance on the tests, question by question; and enabling the website to accommodate no less than 100 concurrent users.
- Adjustment of fonts to match general personal-computer sets and updating the wording of the questions to be more relevant with the circumstances of patients.
Second-stage system development and assessment:
- The sample group was 32 nurse anesthetist students and 21 first year residents in anesthesiology who underwent system testing during a three-week period.
- Objectives
- To test criterion-referenced tool quality
- To determine learning achievement
- Findings:
- The pre-test and post-test registered 0.48 and 0.50 in item difficulty (p) values; 0.72 and 0.73 in sensitivity indices (s); 0.85 and 0.88 in content validity; concurrent validity through calculation of Pearson Product moment against a standard test of 0.82; and 0.91 reliability for the internal consistency by the Kuder-Richardson method 20.
- The diagnostic tests registered 0.87, 0.91, 0.87 and 0.93, 0.93, 0.86 in item difficulty (p) values; 0.17, 0.11, 0.20 and 0.15, 0.08, 0.21 in sensitivity indices; 0.89, 0.80, 0.95 in content validity; and 0.85, 0.66, 0.95 and 0.91, 0.77, 0.88 reliability for the internal consistency.
- Learning achievement:
- The post-test scores with a full mark of 40, were significantly higher than pre-test scores: 4.52 ± 3.04 against 23.90 ± 7.69 among the nurse student group and 7.60 ± 5.69 and 26.96 ± 7.47 among the resident group.
- Improvement: We chose quality test questions and introduced 'distracters' most often picked by respondents in each pre-test and post-test in developing the tests for our target group.
Third-stage development and assessment: Consisting in a trial application on the target preclinical 3rd year medical students and nurses in critical care unit throughout the country who volunteer to join the study. They are asked to log in to a website to study the required subjects in three weeks. Students' profiles are periodically updated.
- Conditions
- Learning Development
- Being tested
- pretest and posttest scores
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pretest and posttest scoresOther
Also called relative growth scores
pretest and post-test scores are calculated for relative growth scores
| Study group | Role | What they receive |
|---|---|---|
| 3th year medical students | Experimental | Not described Receives: Other: pretest and posttest scores |
| nurses in critical care units | Experimental | Not described Receives: Other: pretest and posttest scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Learning Achievement as a Measure of Relative Growth Scores.
Measured: 1 year
Secondary outcomes (1)
Scores on the Web Record Profiles.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionOct 2015
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning DevelopmentStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phongthara Vichitvejpaisal", Mahidol University
- Investigators
- Phongthara Vichitvejpaisal, M.D., Ph.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627730
- Sponsor's protocol ID
- 029/2554(EC1)
- Acronym
- CAI
- Status last verified
- Mar 2016
- First submitted
- 19 Apr 2012
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Assessment of On-line Computer-Assisted Instruction: Arterial Blood Gases
- ClinicalTrials.gov ID
- NCT01627730
- Acronym / sponsor ID
- CAI / 029/2554(EC1)
- Conditions
- Learning Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 26 Jun 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.
This research work develops a diagnostic and feedback-providing system for self-learning by volunteers who are asked to log in to a website to study the required subjects in three weeks.
The system establishes students' learning weaknesses and offered guidelines for their improvement until all such weaknesses are corrected.
Assessment is based on students' relative growth scores, and their record profiles.
Detailed description
Website development: The www.nmac.in.th website contains the learning courseware database. The program is interactive, with personal files for each student along with other details like code, password, name, surname, date-month-year, test scores, and log-in periods and time.
Students can, on their own, plan their learning for each subject; they are free to record and copy the articles on the website. There is no log-in limit from any place with internet connection around the clock.
Learning courseware: We developed a set of learning courseware of the specified topics as activities and diagnostic tests for arterial blood gases (ABGs).
The activities covered topics under the table of specification, whereas the diagnostic tests probed the weaknesses of students' understanding of activities so as to assess their learning skills in analytical thinking of patients' problems under assorted circumstances to be faced in clinical practice.
Each set of courseware contained three levels: beginner, intermediate, and advanced.
Students are required to pass each in an orderly way, at least once with a minimum score of 80% before advancing to the next level.
Once they have passed certain courseware, they are free to review all learning courseware as often as they wanted to.
Learning sources: Interactive with students, the program identifies learning weaknesses while avoiding giving them direct answers immediately after each test.
What it does is instead to link the student to begin a search for the well-prepared content, which contains details of the subject.
Construction of test forms: Pre-test and post-test forms are designed to be parallel under the table of specification, thus preventing the carry-over effect by testing them three weeks afterward and alternating the questions or changing them.
The tests underwent verification for content validity and had their index of item objective congruence (IOC) determined by four clinical experts.
Deciding whether the tests and behavioral objectives aligned, they set the IOCs at 0.79 for pre-tests and 0.73 for post-tests.
- Two sets of pre-tests and post-tests of 10 questions each, with each question containing four sub-items requiring short answers
- 15 activities and 10 diagnostic tests of the multiple-choice (4) questions
System testing: We introduced the elements, namely the learning courseware, tests, and sources of learning, to the developed system before testing it under the research and development approach, the logical approach, and empirical approach.
Different sample sizes were used, and logical comments were analyzed to test the system efficiency under three stages:
First-stage system development and assessment:
- The sample group was 4 sixth year medical students who underwent system testing during a three-week period
- Objectives:
- To test system operating units and system log-ins
- To test the objectivity of the tools
- Findings:
- The system operating units were flexible to students' interactive behavior, instruction responsiveness, and network connection. Access to the system through the website provided ready access to the information, was user-friendly, and was stable.
- The tools were objective, covered complete details, and were clear, with elements of the subject content in proper order.
- Improvement:
- Making the system interactive with the network; focusing on conciseness; adding channels for answering questionnaires through the website; adding the record on downloading articles from the website; notifying students of their performance on the tests, question by question; and enabling the website to accommodate no less than 100 concurrent users.
- Adjustment of fonts to match general personal-computer sets and updating the wording of the questions to be more relevant with the circumstances of patients.
Second-stage system development and assessment:
- The sample group was 32 nurse anesthetist students and 21 first year residents in anesthesiology who underwent system testing during a three-week period.
- Objectives
- To test criterion-referenced tool quality
- To determine learning achievement
- Findings:
- The pre-test and post-test registered 0.48 and 0.50 in item difficulty (p) values; 0.72 and 0.73 in sensitivity indices (s); 0.85 and 0.88 in content validity; concurrent validity through calculation of Pearson Product moment against a standard test of 0.82; and 0.91 reliability for the internal consistency by the Kuder-Richardson method 20.
- The diagnostic tests registered 0.87, 0.91, 0.87 and 0.93, 0.93, 0.86 in item difficulty (p) values; 0.17, 0.11, 0.20 and 0.15, 0.08, 0.21 in sensitivity indices; 0.89, 0.80, 0.95 in content validity; and 0.85, 0.66, 0.95 and 0.91, 0.77, 0.88 reliability for the internal consistency.
- Learning achievement:
- The post-test scores with a full mark of 40, were significantly higher than pre-test scores: 4.52 ± 3.04 against 23.90 ± 7.69 among the nurse student group and 7.60 ± 5.69 and 26.96 ± 7.47 among the resident group.
- Improvement: We chose quality test questions and introduced 'distracters' most often picked by respondents in each pre-test and post-test in developing the tests for our target group.
Third-stage development and assessment: Consisting in a trial application on the target preclinical 3rd year medical students and nurses in critical care unit throughout the country who volunteer to join the study. They are asked to log in to a website to study the required subjects in three weeks. Students' profiles are periodically updated.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3th year medical students | Experimental | Other: pretest and posttest scores |
| nurses in critical care units | Experimental | Other: pretest and posttest scores |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 3rd year medical students
- Nurses in Critical care unit
Key exclusion criteria (1 listed)
- non-volunteer
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 |
|---|---|---|
| pretest and posttest scoresAlso: relative growth scorespretest and post-test scores are calculated for relative growth scores | Other | 3th year medical students, nurses in critical care units |
Primary outcome
Number of Participants with Learning Achievement as a Measure of Relative Growth Scores.
Time frame: 1 year
1 secondary outcome
Scores on the Web Record Profiles.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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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.
Phongthara Vichitvejpaisal, M.D., Ph.D. principal investigator
Siriraj Hospital
Questions about this trial
What is this clinical trial studying?
A study testing pretest and posttest scores in people with Learning Development, 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 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: status not confirmed, as of the sponsor's last update on 16 Mar 2016. 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?
Results are not available in the source record.
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?
Number of Participants with Learning Achievement as a Measure of Relative Growth Scores. (time frame: 1 year). 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 16 Mar 2016.