EmpathyPHARMSIMNCT04133727
Suiting up to Empathy
A study testing Use of an ageing suit and Polypharmacy workshop in people with Empathy, run by Monash University at 1 site in Malaysia.
Trial summary
Healthcare professionals with a positive attitude and empathetic towards older adults are at a better position to deliver quality healthcare. In this study, the investigators randomized pharmacy students to either a polypharmacy workshop or an immersive aging simulation suit and polypharmacy workshop to examine if… Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Empathy
- What is being tested?
- Use of an ageing suit and Polypharmacy workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2018to 1 Sep 2018
- 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 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All pharmacy students enrolled in the Pharmacy program
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suiting up to Teach Pharmacy Students Empathy
Healthcare professionals with a positive attitude and empathetic towards older adults are at a better position to deliver quality healthcare. In this study, the investigators randomized pharmacy students to either a polypharmacy workshop or an immersive aging simulation suit and polypharmacy workshop to examine if simulation will enhance empathy levels among students
Read the detailed description
Healthcare professionals with a positive attitude and empathetic towards older adults are at a better position to deliver quality healthcare. In this study, the investigators randomized pharmacy students to either a polypharmacy workshop or an immersive aging simulation suit and polypharmacy workshop to examine if simulation will enhance empathy levels among students. This will be performed in all year 1 pharmacy students
- Conditions
- Empathy
- Being tested
- Use of an ageing suit, Polypharmacy workshop
- Keywords
- randomised, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of an ageing suitBehavioural
Also called PAUL Simulation Suit
The simulation suit consists of a pair glasses which simulates narrowing of visual field; a pair of gloves ; a vest ; elbow and knee wraps and sand bags worn on the wrists and ankles
Polypharmacy workshopOther
Also called Medication review polypharmacy workshop
Participants will conduct a full medication review for older adults within 1 hour and develop a medication list which can be used for counselling of older adults
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group will wear a simulation suit in which will mimic the physical limitations experienced by older adults. In addition, they will participate in a polypharmacy workshop which allows them to communicate with older adults Receives: Behavioral: Use of an ageing suit |
| Control | Active comparator | This group will participate in a polypharmacy workshop which allows them to communicate with older adults Receives: Other: Polypharmacy workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Jefferson Empathy Scale
Change in empathy
Measured: Baseline at Week 0 to Post Workshop at Week 12
Secondary outcomes (1)
Subjective global question seeking opinion on the workshop and activity
Open ended qualitative response
Measured: Post intervention at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Jun 2018
- Primary completion1 Aug 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmpathyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaun Lee Wen Huey, Monash University
- Investigators
- Shaun Lee, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133727
- Sponsor's protocol ID
- PHARMSIM
- Acronym
- PHARMSIM
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be requested from PI upon reasonable request
Publications
Lee SWH, Teh PL. "Suiting Up" to Enhance Empathy Toward Aging: A Randomized Controlled Study. Front Public Health. 2020 Aug 25;8:376. doi: 10.3389/fpubh.2020.00376. eCollection 2020.
PubMed 32984232
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suiting up to Teach Pharmacy Students Empathy
- ClinicalTrials.gov ID
- NCT04133727
- Acronym / sponsor ID
- PHARMSIM / PHARMSIM
- Conditions
- Empathy
- Keywords
- randomised, simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 21 Oct 2019 (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.
Healthcare professionals with a positive attitude and empathetic towards older adults are at a better position to deliver quality healthcare. In this study, the investigators randomized pharmacy students to either a polypharmacy workshop or an immersive aging simulation suit and polypharmacy workshop to examine if simulation will enhance empathy levels among students
Detailed description
Healthcare professionals with a positive attitude and empathetic towards older adults are at a better position to deliver quality healthcare. In this study, the investigators randomized pharmacy students to either a polypharmacy workshop or an immersive aging simulation suit and polypharmacy workshop to examine if simulation will enhance empathy levels among students. This will be performed in all year 1 pharmacy students
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Use of an ageing suitIntervention group will wear a simulation suit in which will mimic the physical limitations experienced by older adults. In addition, they will participate in a polypharmacy workshop which allows them to communicate with older adults |
| Control | Active comparator | Other: Polypharmacy workshopThis group will participate in a polypharmacy workshop which allows them to communicate with older adults |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All pharmacy students enrolled in the Pharmacy program
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Use of an ageing suitAlso: PAUL Simulation SuitThe simulation suit consists of a pair glasses which simulates narrowing of visual field; a pair of gloves ; a vest ; elbow and knee wraps and sand bags worn on the wrists and ankles | Behavioural | Intervention |
| Polypharmacy workshopAlso: Medication review polypharmacy workshopParticipants will conduct a full medication review for older adults within 1 hour and develop a medication list which can be used for counselling of older adults | Other | Control |
Primary outcome
Changes in Jefferson Empathy Scale
Time frame: Baseline at Week 0 to Post Workshop at Week 12
Change in empathy
1 secondary outcome
Subjective global question seeking opinion on the workshop and activity
Time frame: Post intervention at Week 12
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 21 Oct 2019.
- Derived from this study: PubMed 32984232Lee SWH, Teh PL. "Suiting Up" to Enhance Empathy Toward Aging: A Randomized Controlled Study. Front Public Health. 2020 Aug 25;8:376. doi: 10.3389/fpubh.2020.00376. eCollection 2020.
- Individual participant dataSharing planned: No. IPD can be requested from PI upon 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.
Shaun Lee principal investigator
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of an ageing suit and Polypharmacy workshop in people with Empathy, run by Monash University 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 1 inclusion and 0 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 21 Oct 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 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?
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?
Changes in Jefferson Empathy Scale (time frame: Baseline at Week 0 to Post Workshop at Week 12). 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 NCT04133727, which also lists 1 linked publication.
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 21 Oct 2019.