FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/12/030094 [Registered on: 29/12/2020] Trial Registered Prospectively
Last Modified On: 28/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   In depth interview- Qualitative study 
Study Design  Other 
Public Title of Study   To understand and study the experiences of patients and doctors at the COVID-19 isolation wards  
Scientific Title of Study   Experiences of patients and healthcare professionals during hospital-based source isolation for COVID-19. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Viola Dsouza 
Designation  PhD Scholar 
Affiliation  Prasanna School of Public Health (PSPH) 
Address  Room No 70, Department of Health Policy, Prasanna School of Public Health (PSPH), Manipal Academy of Higher Education, Opp Tiger Circle, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09380557809  
Fax    
Email  viola.dsouza@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lena Ashok 
Designation  Associate Professor 
Affiliation  Prasanna School of Public Health (PSPH) 
Address  Room no 39, Department of Global Health, Prasanna School of Public Health (PSPH), Manipal Academy of Higher Education, Opp Tiger Circle, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8310422623  
Fax    
Email  lena.ashok@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Lena Ashok 
Designation  Associate Professor 
Affiliation  Prasanna School of Public Health (PSPH) 
Address  Room No 39, Department of Global Health, Prasanna School of Public Health (PSPH), Manipal Academy of Higher Education, Opp Tiger Circle, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8310422623  
Fax    
Email  lena.ashok@manipal.edu  
 
Source of Monetary or Material Support  
Prasanna School of Public Health (PSPH), Manipal Academy of Higher Education (MAHE), Manipal 
 
Primary Sponsor  
Name  Viola Dsouza 
Address  Prasanna School of Public Health(PSPH), Manipal Academy of Higher Education (MAHE), Opp Tiger Circle, Manipal 
Type of Sponsor  Other [SELF Sponsored ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Viola Dsouza  Kasturba Hospital, Manipal  COVID isolation ward, Department of Medicine, Kasturba Hospital, Manipal Academy of Higher Education(MAHE), Manipal
Udupi
KARNATAKA 
9380557809

viola.dsouza@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Doctors working in COVID-19 isolation ward from the department of medicine  
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Symptomatic COVID-19 positive patients who were enrolled in an isolation ward for over 5
days’ stay and those who are above 18 years of age irrespective of gender, socioeconomic status,
comorbidities will be included. COVID -19 patients admitted in isolation wards will be included. Doctors working in COVID-19 isolation ward from the department of medicine will be included in the study.
 
 
ExclusionCriteria 
Details  Asymptomatic patients, below 18 years and above 75 years will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
We will learn about the experience of COVID-19 patients during their stay in isolation wards.   At the baseline (while administering the questionnaire) 
 
Secondary Outcome  
Outcome  TimePoints 
We will explore the experiences of doctors providing care in isolation wards of the tertiary hospital.  At the baseline (while administering the questionnaire) 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Hospital infection control and public health interventions recommend isolation of suspected and confirmed cases of COVID 19 to break the chain of transmission. As the numbers of infected individuals rose, the judicial use of resources demanded that only patients with moderate to severe symptoms requiring medical care are to be admitted to Dedicated COVID Health Centre (DCHC) or Dedicated COVID Hospital (DCH). Statistics show that 1 in 5 people affected by COVID

19 need hospitalization. That means almost 6 lakh people could have been in and out of isolation in hospital settings across the nation during the past few months. The ground data on how many people are in isolation is not available as the situation is still developing. The guidelines strictly recommend that suspect and confirmed cases should not be allowed to mix under any circumstances. These guidelines are operating on the basis of basic principles of resource allocation, case surveillance and public health measures such as isolation in single rooms or isolation wards in order to break the chain of transmission.


While a large majority of confirmed cases are showing mild symptoms and many are asymptomatic, and therefore quarantined or isolated at home, a significant number of individuals with clinical severity of symptoms are currently in these centres. Source isolation during epidemics often causes psychological and non-psychological outcomes in the patients. Existing reviews on the subject reveals that isolation can give rise to circumstances that deteriorate the mental well-being and safe behaviour in the patient. Higher instances of depression, anxiety and anger are seen in patients who experience the implementation of rigid contact precautions. 


This study is an inquiry into the conditions that patients with moderate and severe illness were exposed to during isolation at the COVID-19 centres. Research on patient perspectives of ‘good doctors’ shows that patients and their families desired to build trust with the attending healthcare provider. Their need for information, education and empowerment was left unmet due to time constraints or lack of inclination of doctors to involve in activities that build these qualities in the patients. On the other end of the spectrum are the masses of physicians and other healthcare staff who describe themselves as ‘saturated’. The pandemic has unleashed burnout among health care workers, the effects of which varies based on age and gender. Many health care professionals encounter this state of physical, emotional, and mental exhaustion due to the demands on their bodies and mind at work and many are also experiencing personal burnout

 
Close