| CTRI Number |
CTRI/2021/01/030414 [Registered on: 12/01/2021] Trial Registered Prospectively |
| Last Modified On: |
23/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Healthcare workers reflections on COVID 19 pandemic |
|
Scientific Title of Study
|
Reflections of COVID-19 Health Care Workers: a qualitative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhalendu Vaishnav |
| Designation |
Professor and Head |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department of Medicine
Pramukhswami Medical College, Shree Krishna Hospital
Karamsad
Anand GUJARAT 388325 India |
| Phone |
9825717481 |
| Fax |
|
| Email |
bhalendusv@charutarhealth.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bhalendu Vaishnav |
| Designation |
Professor and Head |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department of Medicine
Pramukhswami Medical College, Shree Krishna Hospital
Karamsad
Anand GUJARAT 388325 India |
| Phone |
9825717481 |
| Fax |
|
| Email |
bhalendusv@charutarhealth.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhalendu Vaishnav |
| Designation |
Professor and Head |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department of Medicine
Pramukhswami Medical College, Shree Krishna Hospital
Karamsad
Anand GUJARAT 388325 India |
| Phone |
9825717481 |
| Fax |
|
| Email |
bhalendusv@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| Pramukhswami Medical College,Karamsad,Gujarat |
|
|
Primary Sponsor
|
| Name |
Pramukhswami Medical College |
| Address |
Department of Medicine
Pramukhswami Medical College, Shree Krishna Hospital
Karamsad |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Bhalendu Vaishnav |
Pramukhswami Medical College |
Academic auditorium,
Department of Medicine
Pramukhswami Medical Collegee Anand GUJARAT |
9825717481
bhalendusv@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - 2 H M PATEL CENTRE FOR MEDICAL CARE AND EDUCATION, KARAMSAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthcare professionals involved in care of COVID19 patients |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Healthcare workers (residents and faculty members) who have completed at least one posting COVID wards and willing to give consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Allow recording and analysis of reflections of healthcare workers engaged in care of COVID patients |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensitization and Empowerment of Healthcare workers for handling possible future pandemics |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
21/01/2021 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The COVID-19 outbreak has been an unprecedented event which has taken the humanity as a whole and health care services in particular by storm. It has been a challenging time for health care workers who have been caring for patients in the COVID-19 isolation hospitals. Little attention has been given to evaluating the impact of working in pandemic on health care workers’ (HCW) own perspectives in Indian context. This study is needed to uncover what has been the impact of working in pandemic on health care workers’ perspectives and support needs in various sub-themes such as Physical health, safety and security,Concerns for self,Concerns for others,Practical and environmental issues, Workload etc. Methodology: HCW [Residents / Consultants] who are willing and consenting to participate in the study would be called for a Focus-group discussion. Invitation for participation would be sent by Nodal Officer, COVID hospital (PI). Minimum size for the focus-group would be 8 and maximum not more than 12. We would try to keep equal or almost equal gender distribution. The focus group would be conducted by team members AP and JG. They are suitable for this as both have neither been involved in COVID duty. Session would be audio recorded and transcribed for further analysis. Ethical issues: Confidentiality will be maintained by undertaking following steps:
1. The transcription would be done by the study team members. The transcriptions would not use individual identity of the study participants. Codes would be assigned to the participants in transcriptions e.g. P1, P2 etc. 2. The analysis would be based on the transcribed content. It would be done by team members (BSV and JV) who will be blind to the identity of the participants. 3. Audio recording would only be in possessions of the AP and JG. And will be kept under password protected folder.
|