Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Innovation of Audio-Visual Triage System in Combating the Spread of COVID-19 Infection and Its Efficacy: A Novel Strategy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04621214
Recruitment Status : Completed
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Muhammad Mansoor Hafeez, University of Lahore

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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%.

Condition or disease Intervention/treatment
Audio-Visual Triage System Anxiety Levels COVID-19 Spread GAD-7 Score Healthcare Professionals Screening Strategy Device: Audio-Visual Triage System (AVT)

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Innovation of Audio-Visual Triage System in Combating the Spread of COVID-19 Infection and Its Efficacy: A Novel Strategy
Actual Study Start Date : March 21, 2020
Actual Primary Completion Date : April 28, 2020
Actual Study Completion Date : April 28, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Group-A
Group A were performing their duties on visual triage
 Device: 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
Group-B
Group A were performing their duties on Audio-visual triage
 Device: 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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%



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Asymptomatic Healthy
Criteria

Inclusion Criteria:

  • Participants performing their duty on visual triage.

Exclusion Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621214


Locations
Layout table for location information
Pakistan
The University of Lahore
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
University of Lahore
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr Muhammad Mansoor Hafeez, Assistant Professor, University of Lahore
ClinicalTrials.gov Identifier: NCT04621214    
Other Study ID Numbers: IRBEC/BIH/013-2020
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases