| CTRI Number |
CTRI/2024/12/078829 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Long term impact of COVID-19 infection among Nurses |
|
Scientific Title of Study
|
Long term impact of COVID infection among Nurses |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Kusum Gurung |
| Designation |
Ph.D student |
| Affiliation |
Ramaiah Institute of Nursing Education & Research |
| Address |
Ramaiah Institute of Nursing Education and Research, msrit post, msr nagar, Department of Mental Health Nursing, Room no:012
Bangalore
KARNATAKA
560054
India |
| Phone |
9916945152 |
| Fax |
|
| Email |
kusumgrg1221@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Balamurugan |
| Designation |
Asst. Professor of Nursing and Guide |
| Affiliation |
National Institute of Mental Health and Neuroscience |
| Address |
National Institute of Mental Health and Neuroscience, National Apex Coordinating Centre for Tele MANAS, Department of psychiatry, Bengaluru-560029, Karnataka, India
Bangalore
KARNATAKA
560029
India |
| Phone |
9916324414 |
| Fax |
|
| Email |
dr.g.balamurugan1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Balamurugan |
| Designation |
Asst. Professor of Nursing and Guide |
| Affiliation |
National Institute of Mental Health and Neuroscience |
| Address |
National Institute of Mental Health and Neuroscience, National Apex Coordinating Centre for Tele MANAS, Department of psychiatry, Bengaluru-560029, Karnataka, India
Bangalore
KARNATAKA
560029
India |
| Phone |
9916324414 |
| Fax |
|
| Email |
dr.g.balamurugan1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramaiah Medical College Hospital, MSRIT post, MSR nagar, Bangalore-560054, Karnataka |
|
|
Primary Sponsor
|
| Name |
Mrs Kusum Gurung |
| Address |
Ramaiah Institute of Nursing Education and Research, MSRIT post, MSR nagar, Department of Mental Health Nursing, Bengaluru-560054, Karnataka, India |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sheikh Mohammad Aslam |
Ramaiah Medical College Hospital |
MSRIT post, MSR nagar, Department of Medicine, Bengaluru-560054, Karnataka, India
Bangalore
KARNATAKA |
9448450678
shaikhmohammedas.rmc@msruas.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The university ethics committee for Human trials of MS Ramaiah University of Applied Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post covid infection |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)previously diagnosed as COVID-19 and confirmed by polymerase chain reaction (PCR-for-COVID)
2)had worked in covid designated hospital
3)able to comprehend English/ Hindi/ Kannada
|
|
| ExclusionCriteria |
| Details |
1)any medical illness causing intellectual subnormalcy
2)currently with organic mental disorder (head injury, tumors and CNS infection) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)prevalence and severity of long-term COVID-19 impacts among nurses.
2)Identification of any patterns or predictors of severe physical or cognitive symptoms. |
2 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Insightful narratives describing nurses’ personal and professional challenges post-COVID-19. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
15/01/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a mixed method study to assess long term impact of Covid-19 infection among 140 Nurses at tertiary care hospitals, Bangalore, India. Participating nurses should have been previously diagnosed as COVID-19 and confirmed by polymerase chain reaction (PCR-for-COVID) and had worked in covid designated hospital during COVID pandemic. Quantitative data are collected utilizing tools such as sociodemographic profile, Fatigue Assessment Scale (FAS), Pittsburgh Sleep Quality Index (PSQI), Brain fog scale (BFS) and Quantitative informations will be collected by conducting Focused group discussion. The primary outcome of the study is to gain Insights into the prevalence and severity of long-term COVID-19 impacts among nurses, and Identification of any patterns or predictors of severe physical or cognitive symptoms and the secondary objective is to obtain narratives describing nurses’ personal and professional challenges post-COVID-19. |