Audio-Visual Triage SystemNCT04621214
Innovation of Audio-Visual Triage System in Combating the Spread of COVID-19 Infection and Its Efficacy: A Novel Strategy
An observational study of Audio-Visual Triage System and Anxiety Levels, run by University of Lahore at 1 site in Pakistan.
Trial summary
During the novel coronavirus pandemic, also known as SARS-CoV-2 or COVID-19 pandemic, frontline healthcare professionals suffered psychological as well as pathological trauma due to the lack of preparation to cope with this unforeseen situation. Read more about this study
- Who is it for?
- Ages 20 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Audio-Visual Triage System, Anxiety Levels, COVID-19 Spread
- What is being tested?
- Audio-Visual Triage System (AVT)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Mar 2020to 28 Apr 2020
- 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 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Asymptomatic Healthy
Who may be able to join
- Participants performing their duty on visual triage.
Who cannot join
- Those participants having previous psychological illness, frequently used to use the washroom, had non-serious attitude and poor compliance with the protocols of wearing PPEs were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
During the novel coronavirus pandemic, also known as SARS-CoV-2 or COVID-19 pandemic, frontline healthcare professionals suffered psychological as well as pathological trauma due to the lack of preparation to cope with this unforeseen situation. The protocols to prevent the spread of this disease proved to be less effective than anticipated. In these circumstances, improvement of the existing triage system was felt and an AUDIO-VISUAL TRIAGE (AVT) system was introduced to enhance confidence as well as increase the safety of frontline healthcare professionals. The current analysis was performed from March 21, 2020, to April 28, 2020, until the completion of sixty response forms, at Bahria Town International Hospital, Lahore. Thirty participants (Group A) deployed on visual triage and other thirty (Group B) on Audio-Visual triage for screening suspected cases of COVID-19 infection. Anxiety levels were measured by using the GAD-7 scoring system and the participants of both groups were periodically tested for COVID-19 infection by PCR. Independent t-test was used to evaluate the significance of different variables at a confidence level of 95%.
Read the detailed description
A novel strategy 'Audio-Visual Triage' was introduced to boost up the confidence levels, lower down the anxiety levels and the most important factor is to reduce the risk of COVID-19 infection spread. This Triage system included Audio system to communicate with patients and access the COVID-19 infection status at recommended distance of 6 feet. The main disturbing factors that were noted on Visual triage system were, 1). Close contact of healthcare professionals with patients and attends, 2). Fear of transmission of infection lead to higher levels of anxiety. To assess the efficiency of AVT Anxiety level were analyzed by using Spitzer et al., 2006, General Anxiety Disorder-7 (GAD-7) scoring system and outcomes were assessed where a score less than 5 is taken as no anxiety, 5-9 interpreted as mild anxiety, 10-14 moderate anxiety, and ≥ 15 as severe anxiety levels.
- Conditions
- Audio-Visual Triage System, Anxiety Levels, COVID-19 Spread, GAD-7 Score, Healthcare Professionals, Screening Strategy
- Being tested
- Audio-Visual Triage System (AVT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio-Visual Triage System (AVT)Device
Audio System was added to visual triage that resulted in an AVT. Protocols of AVT included, a medical personal sits on TRIAGE DESK (with glass barrier sheet on it) wearing personal protective equipment (PPE) at a distance of more than 6 feet from the PATIENT DESK. Both desks are connected with Non-touchable MIC SYSTEM for communication
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Group A were performing their duties on visual triage Receives: Device: Audio-Visual Triage System (AVT) | |
| Group-B | Group A were performing their duties on Audio-visual triage Receives: Device: Audio-Visual Triage System (AVT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymerase chain reaction (PCR) to detect SARS-CoV-2 virus
Every participant was test for COVID-19 infection by PCR. At the end of the study we compare the Number of participant infected by Corona virus in Both groups.
Measured: 12-24 hours
General Anxiety Disorder-7 (GAD-7) scoring system
The GAD-7 is used to measure the severity of anxiety. Score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%) and post-traumatic stress disorder (sensitivity 66%, specificity 81%
Measured: 15 - 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start21 Mar 2020
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Audio-Visual Triage SystemStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Muhammad Mansoor Hafeez, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621214
- Sponsor's protocol ID
- IRBEC/BIH/013-2020
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation of Audio-Visual Triage System in Combating the Spread of COVID-19 Infection and Its Efficacy: A Novel Strategy
- ClinicalTrials.gov ID
- NCT04621214
- Acronym / sponsor ID
- IRBEC/BIH/013-2020
- Conditions
- Audio-Visual Triage System, Anxiety Levels, COVID-19 Spread, GAD-7 Score, Healthcare Professionals, Screening Strategy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 21 Mar 2020 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 9 Nov 2020 (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.
During the novel coronavirus pandemic, also known as SARS-CoV-2 or COVID-19 pandemic, frontline healthcare professionals suffered psychological as well as pathological trauma due to the lack of preparation to cope with this unforeseen situation. The protocols to prevent the spread of this disease proved to be less effective than anticipated. In these circumstances, improvement of the existing triage system was felt and an AUDIO-VISUAL TRIAGE (AVT) system was introduced to enhance confidence as well as increase the safety of frontline healthcare professionals. The current analysis was performed from March 21, 2020, to April 28, 2020, until the completion of sixty response forms, at Bahria Town International Hospital, Lahore. Thirty participants (Group A) deployed on visual triage and other thirty (Group B) on Audio-Visual triage for screening suspected cases of COVID-19 infection. Anxiety levels were measured by using the GAD-7 scoring system and the participants of both groups were periodically tested for COVID-19 infection by PCR. Independent t-test was used to evaluate the significance of different variables at a confidence level of 95%.
Detailed description
A novel strategy 'Audio-Visual Triage' was introduced to boost up the confidence levels, lower down the anxiety levels and the most important factor is to reduce the risk of COVID-19 infection spread. This Triage system included Audio system to communicate with patients and access the COVID-19 infection status at recommended distance of 6 feet. The main disturbing factors that were noted on Visual triage system were, 1). Close contact of healthcare professionals with patients and attends, 2). Fear of transmission of infection lead to higher levels of anxiety. To assess the efficiency of AVT Anxiety level were analyzed by using Spitzer et al., 2006, General Anxiety Disorder-7 (GAD-7) scoring system and outcomes were assessed where a score less than 5 is taken as no anxiety, 5-9 interpreted as mild anxiety, 10-14 moderate anxiety, and ≥ 15 as severe anxiety levels.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A | – | Device: Audio-Visual Triage System (AVT)Group A were performing their duties on visual triage |
| Group-B | – | Device: Audio-Visual Triage System (AVT)Group A were performing their duties on Audio-visual triage |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Asymptomatic Healthy
Key inclusion criteria (1 listed)
- Participants performing their duty on visual triage.
Key exclusion criteria (1 listed)
- Those participants having previous psychological illness, frequently used to use the washroom, had non-serious attitude and poor compliance with the protocols of wearing PPEs were excluded from the study.
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 |
|---|---|---|
| Audio-Visual Triage System (AVT)Audio System was added to visual triage that resulted in an AVT. Protocols of AVT included, a medical personal sits on TRIAGE DESK (with glass barrier sheet on it) wearing personal protective equipment (PPE) at a distance of more than 6 feet from the PATIENT DESK. Both desks are connected with Non-touchable MIC SYSTEM for communication | Device | Group-A, Group-B |
Primary outcome
Polymerase chain reaction (PCR) to detect SARS-CoV-2 virus
Time frame: 12-24 hours
Every participant was test for COVID-19 infection by PCR. At the end of the study we compare the Number of participant infected by Corona virus in Both groups.
General Anxiety Disorder-7 (GAD-7) scoring system
Time frame: 15 - 20 minutes
The GAD-7 is used to measure the severity of anxiety. Score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%) and post-traumatic stress disorder (sensitivity 66%, specificity 81%
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 9 Nov 2020.
- Individual participant dataSharing planned: No
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 Audio-Visual Triage System and Anxiety Levels, run by University of Lahore at 1 site in Pakistan.
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 9 Nov 2020. 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 Pakistan. 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?
Polymerase chain reaction (PCR) to detect SARS-CoV-2 virus (time frame: 12-24 hours). The study lists 2 primary outcomes in all. 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 9 Nov 2020.