Use of Simucase for Clinical Learning in Malaysia

January 15, 2025 updated by: Farahiyah Wan Yunus, National University of Malaysia

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Farahiyah Wan Yunus, Doctor of Philosophy
  • Phone Number: +60122269537
  • Email: wyfarah85@gmail.com

Study Contact Backup

Study Locations

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50300
        • National University of Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

• International students Students who are not willing to participate in this program during the semester break.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: SimucaseTM
The experiment group - who will receive the clinical learning method using SimucaseTM
Other: SimucaseTM
experiment group - who will receive the clinical learning method using SimucaseTM
Active Comparator: Conventional clinical learning
The control group - which will accept conventional clinical learning methods such as problem-based learning case-study case studies
Other: Conventional Clinical Learning
Problem-based learning case-study case studies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One (1) week of post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Malaysia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universiti Putra Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Farahiyah Wan Yunus, Doctor of Philosophy, National University of Malaysia
  • Study Director: Muhammad H Romli, Doctor of Philosophy, Universiti Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JEP-2024-967

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

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