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
|
|
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
|
|
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
|
|
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 |