UsabilityNCT04070261
Usability Comparison of a mHealth Application for Pre-anesthesia Evaluation Before and After Re-design of User Interface
An observational study of Usability and Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Pre-anesthesia assessment is an important part of anesthesiologists daily routine. A thorough assessment leads to an impeccable anesthesia plan. In the past, the department of anesthesiologist in NTUH (National Taiwan University Hospital) utilizes paper assessment form. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Usability, Anesthesia
- What is being tested?
- iOS application usability test
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2019to 31 Jul 2022
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Enroll the anesthesiologists and anesthesiology residents in NTUH
Who may be able to join
- anesthesiologists in NTUH
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Pre-anesthesia assessment is an important part of anesthesiologists daily routine. A thorough assessment leads to an impeccable anesthesia plan. In the past, the department of anesthesiologist in NTUH (National Taiwan University Hospital) utilizes paper assessment form. As government policy leans towards digitization, the department of anesthesiologist in NTUH collaborates with the information technology office to develop an electronic pre-anesthesia assessment system called EVAN, which is an iOS based application (App). EVAN includes an anesthesia patient list, patient EMR (electronic medical record) and pre-anesthesia assessment form. EVAN was online since March, 2018.
This is an observational research to investigate the user experience and improve the user interface of EVAN.
This research subjects include anesthesiologists from NTUH. This research has three parts: user tasks, questionnaires, and a semi-structured interview. First, the research assistant will record how the user use the App to complete the tasks, which includes video recording and App monitoring. After the tasks is completed, the subject will write a questionnaire. Then the principal investigator will give an interview for feedbacks from the users.
- Conditions
- Usability, Anesthesia
- Being tested
- iOS application usability test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iOS application usability testOther
user tasks, questionnaires, semi-structured interviews
| Study group | Role | What they receive |
|---|---|---|
| User | Not described Receives: Other: iOS application usability test |
What is being measured
The primary outcome is the main question the study is designed to answer.
task complete time
the time duration the user needs to complete the user tasks
Measured: the duration the user needs to complete the tasks, usually within 10 minutes
Secondary outcomes (1)
questionnaire grading
user questionnaire grading
Measured: after the user questionnaire completion, usually within 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Oct 2019
- Primary completion14 Mar 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UsabilityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070261
- Sponsor's protocol ID
- 201904098RINC
- Status last verified
- Mar 2023
- First submitted
- 15 Aug 2019
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Comparison of a mHealth Application for Pre-anesthesia Evaluation Before and After Re-design of User Interface
- ClinicalTrials.gov ID
- NCT04070261
- Acronym / sponsor ID
- 201904098RINC
- Conditions
- Usability, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 28 Aug 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.
Pre-anesthesia assessment is an important part of anesthesiologists daily routine. A thorough assessment leads to an impeccable anesthesia plan. In the past, the department of anesthesiologist in NTUH (National Taiwan University Hospital) utilizes paper assessment form. As government policy leans towards digitization, the department of anesthesiologist in NTUH collaborates with the information technology office to develop an electronic pre-anesthesia assessment system called EVAN, which is an iOS based application (App). EVAN includes an anesthesia patient list, patient EMR (electronic medical record) and pre-anesthesia assessment form. EVAN was online since March, 2018.
This is an observational research to investigate the user experience and improve the user interface of EVAN.
This research subjects include anesthesiologists from NTUH. This research has three parts: user tasks, questionnaires, and a semi-structured interview. First, the research assistant will record how the user use the App to complete the tasks, which includes video recording and App monitoring. After the tasks is completed, the subject will write a questionnaire. Then the principal investigator will give an interview for feedbacks from the users.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| User | – | Other: iOS application usability test |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Enroll the anesthesiologists and anesthesiology residents in NTUH
Key inclusion criteria (1 listed)
- anesthesiologists in NTUH
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| iOS application usability testuser tasks, questionnaires, semi-structured interviews | Other | User |
Primary outcome
task complete time
Time frame: the duration the user needs to complete the tasks, usually within 10 minutes
the time duration the user needs to complete the user tasks
1 secondary outcome
questionnaire grading
Time frame: after the user questionnaire completion, usually within 1 minutes
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 28 Mar 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Usability and Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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: finished, as of the sponsor's last update on 28 Mar 2023. 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 Taiwan. 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?
task complete time (time frame: the duration the user needs to complete the tasks, usually within 10 minutes). 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 28 Mar 2023.