NCT04621214

Brief 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. 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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 4, 2020

Last Update Submit

November 6, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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%

    15 - 20 minutes

Study Arms (2)

Group-A

Group A were performing their duties on visual triage

Device: Audio-Visual Triage System (AVT)

Group-B

Group A were performing their duties on Audio-visual triage

Device: Audio-Visual Triage System (AVT)

Interventions

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

Group-AGroup-B

Eligibility Criteria

Age20 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Asymptomatic Healthy

You may qualify if:

  • Participants performing their duty on visual triage.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 9, 2020

Study Start

March 21, 2020

Primary Completion

April 28, 2020

Study Completion

April 28, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations