Clinical LearningNCT06777550
Use of Simucase for Clinical Learning in Malaysia
A study testing SimucaseTM and Conventional Clinical Learning in people with Clinical Learning, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
The goal of this feasibility study is to the investigate the use of Simucase in the context of health science learning in Malaysia. This study can be a catalyst for technology-based clinical learning than just conventional methods to enrich the learning experience. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Learning
- What is being tested?
- SimucaseTM and Conventional Clinical Learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMalaysia
- Study dates
- 19 Jan 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students from rehabilitation-related academic programmes such as occupational therapy, physiotherapy, speech therapy and audiology.
- Students from undergraduate second to fourth year of the academic programme.
Who cannot join
- International students Students who are not willing to participate in this program during the semester break.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
National University of Malaysia
Kuala Lumpur, Kuala Lumpur, 50300
About this study
Official title: The Feasibility of Using Simucase TM as Part of An Alternative Clinical Learning Method For Malaysian Health Sciences Education
The goal of this feasibility study is to the investigate the use of Simucase in the context of health science learning in Malaysia. This study can be a catalyst for technology-based clinical learning than just conventional methods to enrich the learning experience. This can influence the policy in promoting the effective use of existing commercial technologies in clinical learning for health science programs in Malaysia and can transform national higher education scenario in the future.
An experimental study with 24 participants from the rehabilitation disciplines of audiology, occupational therapy, physiotherapy, and speech therapy method using a pilot study techniques of clinical control studies. Participants will be assigned to either the experimental group who will receive the clinical learning method using SimucaseTM or (ii) the control group - which will accept conventional clinical learning methods such as problem-based learning case-study case studies. The topic of learning is the same for both groups.
Read more
The study hypothesis includes:
- There is a significant difference on clinical skills between SimucaseTM and conventional approach of learning among health science students.
- There is a significant difference on students' satisfaction learning between SimucaseTM and conventional approach of learning among health science students.
Read the detailed description
INTRODUCTION
In line with the changing agenda of the international paradigm that promotes the use of technology in the learning of health studies to overcome problems related to placement, logistics, human resources for supervision, patient aversion and creating a safe and conducive learning environment to form good competencies before stepping into clinical field learning. World bodies such as the World Federation Occupational Therapists allow the replacement of 20% of clinical field training to alternative clinical learning such as the use of technology and tele-health.
This study can be a catalyst for technology-based clinical learning than just conventional methods to enrich the learning experience. This can influence the policy in promoting the effective use of existing commercial technologies in clinical learning for health science programs in Malaysia and can transform national higher education scenario in the future.
PROBLEM STATEMENT
Education research in allied health especially rehabilitation, is more marginalized than medicine or nursing. This retards the advancement of teaching and learning strategies to optimize allied health education. Adopting knowledge from other fields such as medicine and nursing may be less fitting with the allied health education's needs. Therefore, it is essential to tailor the available learning strategies carefully to optimize their learning benefits according to the discipline's needs.
The clinical placement was reported to have missed a substantial learning opportunity due to a lack of theoretical application and weak teaching skills among clinicians. Having clinical simulation to supplement clinical placement was beneficial to optimize the gain from clinical learning as it was constructed on a solid learning theory. Simulation has become more advanced with the current availability of technology in combination with gaming elements. The combination of virtual simulation and gaming element creates substantial learning opportunity based on Kolb's experiential learning model.
RESEARCH OBJECTIVES
Main Objective
- To investigate the applicability of SimucaseTM software for clinical learning among health science students.
Specific Objectives
- To investigate the efficacy of SimucaseTM compared to conventional approach for clinical skills.
- To compare students' satisfaction on learning using SimucaseTM over conventional approach in clinical learning among health science students.
- To explore the feasibility of SimucaseTM as an alternative learning method for clinical learning among health science students.
Study design
The experimental study method used pilot study techniques, clinical control studies is proposed. This method is a high-quality technique to ensure the effectiveness of an intervention is credible.
Study samples
Students will be selected from the disciplines of audiology, occupational therapy, physiotherapy, and speech therapy at an institution. It is expected that 24 students (12 per control and experiment group) for each discipline will be recruited. Only second- to fourth-year students will be recruited, as first-year students have not yet taken any specialized courses in the program, making them unprepared for clinical learning.
Procedure
Each discipline will conduct RCT research separately to reduce the bias of differences between fields of study. Here, each RCT research will divide the students into two groups using sample random sampling, namely (i) the experiment group - who will receive the clinical learning method using SimucaseTM; and (ii) the control group - which will accept conventional clinical learning methods such as problem-based learning case-study case studies. The topic of learning is the same for both groups. It is recommended to have a learning session of two sessions for each group within a week. After the end of the study, the study participants will be evaluated for their performance by answering some survey forms (i.e., SLSQ). Only one data collection time is done (i.e., post-test) only. For ethical purpose, the control group and the experiment group will be cross-over (e.g., swap) on the learning approach to experience both approaches but not evaluated.
- Conditions
- Clinical Learning
- Being tested
- SimucaseTM, Conventional Clinical Learning
- Keywords
- clinical, simucase, health science, education, alternative learning, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimucaseTMOther
experiment group - who will receive the clinical learning method using SimucaseTM
Conventional Clinical LearningOther
Problem-based learning case-study case studies
| Study group | Role | What they receive |
|---|---|---|
| SimucaseTM | Active comparator | The experiment group - who will receive the clinical learning method using SimucaseTM Receives: Other: SimucaseTM |
| Conventional clinical learning | Active comparator | The control group - which will accept conventional clinical learning methods such as problem-based learning case-study case studies Receives: Other: Conventional Clinical Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinical Learning Environment Comparison Survey (CLECS 2.0)
The survey consists of 29 multiple items across various subscales, each representing different aspects of the clinical learning environment, such as communication, critical thinking, and technical skills. Students rate their experiences on a 4-point Likert scale, (4 =well-met, 3 =met, 2 = partially met, 1 = not met) with a not applicable (NA) option. The overall score for each subscale is calculated by averaging the responses for that particular domain, providing insight into specific areas of strength or weakness in the learning environment. The total score is a sum or average of all the subscale scores, offering a comprehensive assessment of the clinical learning environment as perceived by the students. A higher score indicates a better outcome.
Measured: One (1) week of post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start19 Jan 2025 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Clinical LearningStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Putra Malaysia
- Responsible party
- Principal investigator, Farahiyah Wan Yunus, National University of Malaysia
- Investigators
- Farahiyah Wan Yunus, Doctor of Philosophy, Principal investigator, National University of MalaysiaMuhammad H Romli, Doctor of Philosophy, Study director, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777550
- Sponsor's protocol ID
- JEP-2024-967
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
World Federation of Occupational Therapists. (2020). COVID-19 and WFOT minimum education standards statement, 2020. Available: https://www.wfot.org/news/2020/covid-19-and-wfot-minimum-education-standards-statement
Waseh S, Dicker AP. Telemedicine Training in Undergraduate Medical Education: Mixed-Methods Review. JMIR Med Educ. 2019 Apr 8;5(1):e12515. doi: 10.2196/12515.
PubMed 30958269Thomas A, Burns R, Sanseau E, Auerbach M. Tips for Conducting Telesimulation-Based Medical Education. Cureus. 2021 Jan 4;13(1):e12479. doi: 10.7759/cureus.12479.
PubMed 33552792Romli MH, Wan Yunus F, Cheema MS, Abdul Hamid H, Mehat MZ, Md Hashim NF, Foong CC, Hong WH, Jaafar MH. A Meta-synthesis on Technology-Based Learning Among Healthcare Students in Southeast Asia. Med Sci Educ. 2022 May 7;32(3):657-677. doi: 10.1007/s40670-022-01564-3. eCollection 2022 Jun.
PubMed 35573465Romli MH, Foong CC, Hong WH, Subramaniam P, Wan Yunus F. Restructuring education activities for full online learning: findings from a qualitative study with Malaysian nursing students during Covid-19 pandemic. BMC Med Educ. 2022 Jul 11;22(1):535. doi: 10.1186/s12909-022-03587-1.
PubMed 35821126Rezaee M, Rassafiani M, Khankeh H, Hosseini MA. Experiences of occupational therapy students in the first fieldwork education: a qualitative study. Med J Islam Repub Iran. 2014 Oct 11;28:110. eCollection 2014.
PubMed 25664311Praveen, C., Herur, S., Vashisht, S., Venkatesh, V. K. & Senapati, S. (2022). A comparative study on the suitability of virtual labs for school chemistry experiments. Journal of Emerging Investigators, 5(1), 1-9.
Nelson, J. (2017). Using conceptual depth criteria: addressing the challenge of reaching saturation in qualitative research. Qualitative Research, 17(5), 554-570. https://doi.org/10.1177/1468794116679873
Mattila, A., Martin, R.M., DeIuliis, E.D. (2020). Simulated fieldwork: A virtual approach to clinical education. Education Sciences, 10, 272. https://doi.org/10.3390/educsci10100272
Leighton, K. (2015). Development of the Clinical Learning Environment Comparison Survey. Clinical Simulation in Nursing, 11(1), 44-51. doi:10.1016/j.ecns.2014.11.002
Ingwersen K, Lyons N, Hitch D. Perceptions of fieldwork in occupational therapy. Clin Teach. 2017 Feb;14(1):55-59. doi: 10.1111/tct.12518. Epub 2016 Apr 5.
PubMed 27060287Foronda CL, Fernandez-Burgos M, Nadeau C, Kelley CN, Henry MN. Virtual Simulation in Nursing Education: A Systematic Review Spanning 1996 to 2018. Simul Healthc. 2020 Feb;15(1):46-54. doi: 10.1097/SIH.0000000000000411.
PubMed 32028447Emslie B. Clinical occupational therapists' experience of their role as clinical educators during the fieldwork experience of occupational therapy students (master's thesis). South Africa, Stellenbosch University, Stellenbosch; (2012).
DeIuliis, E., Mattila, A., & Martin, R. (2021). Level I FW in a simulated environment: A blueprint on how to use SimucaseTM. Journal of Occupational Therapy Education,5(2). Retrieved from https://encompass.eku.edu/jote/vol5/iss2/15/
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Using Simucase TM as Part of An Alternative Clinical Learning Method For Malaysian Health Sciences Education
- ClinicalTrials.gov ID
- NCT06777550
- Acronym / sponsor ID
- JEP-2024-967
- Conditions
- Clinical Learning
- Keywords
- clinical, simucase, health science, education, alternative learning, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Universiti Putra Malaysia
- Study start
- 19 Jan 2025 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 16 Jan 2025 (actual)
- 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.
The goal of this feasibility study is to the investigate the use of Simucase in the context of health science learning in Malaysia. This study can be a catalyst for technology-based clinical learning than just conventional methods to enrich the learning experience. This can influence the policy in promoting the effective use of existing commercial technologies in clinical learning for health science programs in Malaysia and can transform national higher education scenario in the future.
An experimental study with 24 participants from the rehabilitation disciplines of audiology, occupational therapy, physiotherapy, and speech therapy method using a pilot study techniques of clinical control studies. Participants will be assigned to either the experimental group who will receive the clinical learning method using SimucaseTM or (ii) the control group - which will accept conventional clinical learning methods such as problem-based learning case-study case studies. The topic of learning is the same for both groups.
The study hypothesis includes:
- There is a significant difference on clinical skills between SimucaseTM and conventional approach of learning among health science students.
- There is a significant difference on students' satisfaction learning between SimucaseTM and conventional approach of learning among health science students.
Detailed description
INTRODUCTION
In line with the changing agenda of the international paradigm that promotes the use of technology in the learning of health studies to overcome problems related to placement, logistics, human resources for supervision, patient aversion and creating a safe and conducive learning environment to form good competencies before stepping into clinical field learning. World bodies such as the World Federation Occupational Therapists allow the replacement of 20% of clinical field training to alternative clinical learning such as the use of technology and tele-health.
This study can be a catalyst for technology-based clinical learning than just conventional methods to enrich the learning experience. This can influence the policy in promoting the effective use of existing commercial technologies in clinical learning for health science programs in Malaysia and can transform national higher education scenario in the future.
PROBLEM STATEMENT
Education research in allied health especially rehabilitation, is more marginalized than medicine or nursing. This retards the advancement of teaching and learning strategies to optimize allied health education. Adopting knowledge from other fields such as medicine and nursing may be less fitting with the allied health education's needs. Therefore, it is essential to tailor the available learning strategies carefully to optimize their learning benefits according to the discipline's needs.
The clinical placement was reported to have missed a substantial learning opportunity due to a lack of theoretical application and weak teaching skills among clinicians. Having clinical simulation to supplement clinical placement was beneficial to optimize the gain from clinical learning as it was constructed on a solid learning theory. Simulation has become more advanced with the current availability of technology in combination with gaming elements. The combination of virtual simulation and gaming element creates substantial learning opportunity based on Kolb's experiential learning model.
RESEARCH OBJECTIVES
Main Objective
- To investigate the applicability of SimucaseTM software for clinical learning among health science students.
Specific Objectives
- To investigate the efficacy of SimucaseTM compared to conventional approach for clinical skills.
- To compare students' satisfaction on learning using SimucaseTM over conventional approach in clinical learning among health science students.
- To explore the feasibility of SimucaseTM as an alternative learning method for clinical learning among health science students.
Study design
The experimental study method used pilot study techniques, clinical control studies is proposed. This method is a high-quality technique to ensure the effectiveness of an intervention is credible.
Study samples
Students will be selected from the disciplines of audiology, occupational therapy, physiotherapy, and speech therapy at an institution. It is expected that 24 students (12 per control and experiment group) for each discipline will be recruited. Only second- to fourth-year students will be recruited, as first-year students have not yet taken any specialized courses in the program, making them unprepared for clinical learning.
Procedure
Each discipline will conduct RCT research separately to reduce the bias of differences between fields of study. Here, each RCT research will divide the students into two groups using sample random sampling, namely (i) the experiment group - who will receive the clinical learning method using SimucaseTM; and (ii) the control group - which will accept conventional clinical learning methods such as problem-based learning case-study case studies. The topic of learning is the same for both groups. It is recommended to have a learning session of two sessions for each group within a week. After the end of the study, the study participants will be evaluated for their performance by answering some survey forms (i.e., SLSQ). Only one data collection time is done (i.e., post-test) only. For ethical purpose, the control group and the experiment group will be cross-over (e.g., swap) on the learning approach to experience both approaches but not evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SimucaseTM | Active comparator | Other: SimucaseTMThe experiment group - who will receive the clinical learning method using SimucaseTM |
| Conventional clinical learning | Active comparator | Other: Conventional Clinical LearningThe control group - which will accept conventional clinical learning methods such as problem-based learning case-study case studies |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Students from rehabilitation-related academic programmes such as occupational therapy, physiotherapy, speech therapy and audiology.
- Students from undergraduate second to fourth year of the academic programme.
Key exclusion criteria (1 listed)
- International students Students who are not willing to participate in this program during the semester break.
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 |
|---|---|---|
| SimucaseTMexperiment group - who will receive the clinical learning method using SimucaseTM | Other | SimucaseTM |
| Conventional Clinical LearningProblem-based learning case-study case studies | Other | Conventional clinical learning |
Primary outcome
The Clinical Learning Environment Comparison Survey (CLECS 2.0)
Time frame: One (1) week of post-intervention
The survey consists of 29 multiple items across various subscales, each representing different aspects of the clinical learning environment, such as communication, critical thinking, and technical skills. Students rate their experiences on a 4-point Likert scale, (4 =well-met, 3 =met, 2 = partially met, 1 = not met) with a not applicable (NA) option. The overall score for each subscale is calculated by averaging the responses for that particular domain, providing insight into specific areas of strength or weakness in the learning environment. The total score is a sum or average of all the subscale scores, offering a comprehensive assessment of the clinical learning environment as perceived by the students. A higher score indicates a better outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Results publicationWorld Federation of Occupational Therapists. (2020). COVID-19 and WFOT minimum education standards statement, 2020. Available: https://www.wfot.org/news/2020/covid-19-and-wfot-minimum-education-standards-statement
- Results publication: PubMed 30958269Waseh S, Dicker AP. Telemedicine Training in Undergraduate Medical Education: Mixed-Methods Review. JMIR Med Educ. 2019 Apr 8;5(1):e12515. doi: 10.2196/12515.
- Results publication: PubMed 33552792Thomas A, Burns R, Sanseau E, Auerbach M. Tips for Conducting Telesimulation-Based Medical Education. Cureus. 2021 Jan 4;13(1):e12479. doi: 10.7759/cureus.12479.
- Results publication: PubMed 35573465Romli MH, Wan Yunus F, Cheema MS, Abdul Hamid H, Mehat MZ, Md Hashim NF, Foong CC, Hong WH, Jaafar MH. A Meta-synthesis on Technology-Based Learning Among Healthcare Students in Southeast Asia. Med Sci Educ. 2022 May 7;32(3):657-677. doi: 10.1007/s40670-022-01564-3. eCollection 2022 Jun.
- Results publication: PubMed 35821126Romli MH, Foong CC, Hong WH, Subramaniam P, Wan Yunus F. Restructuring education activities for full online learning: findings from a qualitative study with Malaysian nursing students during Covid-19 pandemic. BMC Med Educ. 2022 Jul 11;22(1):535. doi: 10.1186/s12909-022-03587-1.
- Results publication: PubMed 25664311Rezaee M, Rassafiani M, Khankeh H, Hosseini MA. Experiences of occupational therapy students in the first fieldwork education: a qualitative study. Med J Islam Repub Iran. 2014 Oct 11;28:110. eCollection 2014.
- Results publicationPraveen, C., Herur, S., Vashisht, S., Venkatesh, V. K. & Senapati, S. (2022). A comparative study on the suitability of virtual labs for school chemistry experiments. Journal of Emerging Investigators, 5(1), 1-9.
- Results publicationNelson, J. (2017). Using conceptual depth criteria: addressing the challenge of reaching saturation in qualitative research. Qualitative Research, 17(5), 554-570. https://doi.org/10.1177/1468794116679873
- Results publicationMattila, A., Martin, R.M., DeIuliis, E.D. (2020). Simulated fieldwork: A virtual approach to clinical education. Education Sciences, 10, 272. https://doi.org/10.3390/educsci10100272
- Results publicationLeighton, K. (2015). Development of the Clinical Learning Environment Comparison Survey. Clinical Simulation in Nursing, 11(1), 44-51. doi:10.1016/j.ecns.2014.11.002
- Results publication: PubMed 27060287Ingwersen K, Lyons N, Hitch D. Perceptions of fieldwork in occupational therapy. Clin Teach. 2017 Feb;14(1):55-59. doi: 10.1111/tct.12518. Epub 2016 Apr 5.
- Results publication: PubMed 32028447Foronda CL, Fernandez-Burgos M, Nadeau C, Kelley CN, Henry MN. Virtual Simulation in Nursing Education: A Systematic Review Spanning 1996 to 2018. Simul Healthc. 2020 Feb;15(1):46-54. doi: 10.1097/SIH.0000000000000411.
- Individual participant dataSharing planned: Yes
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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.
Farahiyah Wan Yunus, Doctor of Philosophy principal investigator
National University of Malaysia
Muhammad H Romli, Doctor of Philosophy study director
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SimucaseTM and Conventional Clinical Learning in people with Clinical Learning, run by National University of Malaysia at 1 site in Malaysia.
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: opening soon, as of the sponsor's last update on 17 Jan 2025. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farahiyah Wan Yunus, Doctor of Philosophy (+60122269537, wyfarah85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Clinical Learning Environment Comparison Survey (CLECS 2.0) (time frame: One (1) week of 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 NCT06777550, which also lists 14 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 17 Jan 2025.