| CTRI Number |
CTRI/2021/03/032063 [Registered on: 17/03/2021] Trial Registered Prospectively |
| Last Modified On: |
22/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding of tiredness, level of function and quality of life amongst Post-Covid patients who were admitted in hospitals and asked to be home quarantined |
|
Scientific Title of Study
|
Perception of fatigue, functional status and health related quality of life amongst Post-COVID hospitalized and home quarantined patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chhaya V Verma |
| Designation |
Professor and Head of Department |
| Affiliation |
Topiwala National Medical College and B Y L Nair Charitable Hospital |
| Address |
OPD No. 24 N Building Physiotherapy School and Centre Topiwala National Medical College and B Y L Nair Charitable Hospital Dr A L Nair Road Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027515 |
| Fax |
|
| Email |
cvverma100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya V Verma |
| Designation |
Professor and Head of Department |
| Affiliation |
Topiwala National Medical College and B Y L Nair Charitable Hospital |
| Address |
OPD No. 24 N Building Physiotherapy School and Centre Topiwala National Medical College and B Y L Nair Charitable Hospital Dr A L Nair Road Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027515 |
| Fax |
|
| Email |
cvverma100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kevin Thakkar |
| Designation |
Third Year UG Student |
| Affiliation |
Topiwala National Medical College and B Y L Nair Charitable Hospital |
| Address |
OPD No. 24 N Building Physiotherapy School and Centre Topiwala National Medical College and B Y L Nair Charitable Hospital Dr A L Nair Road Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9029452250 |
| Fax |
|
| Email |
kevinthakkar786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Topiwala National Medical College and BYL Nair Ch. Hospital, Mumbai Central-08 |
|
|
Primary Sponsor
|
| Name |
Researcher Self Funded |
| Address |
Physiotherapy School and Centre Topiwala National Medical College and B Y L Nair Charitable Hospital Dr A L Nair Road Mumbai |
| 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 Chhaya V Verma |
Topiwala National Medical College and BYL Nair Charitable Hospital |
OPD No. 24 N Building Physiotherapy School and Centre Topiwala National Medical College and B Y L Nair Charitable Hospital Dr A L Nair Road Mumbai
Mumbai
MAHARASHTRA |
9082797203
cvverma100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department Review Board Physiotherapy School and Centre TNMC and BYLNCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| 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 |
60.00 Year(s) |
| Gender |
Both |
| Details |
Post-COVID patients who have tested negative in RT-PCR Test more than 3 months and less than 6 months ago |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study, Patients not able to apprehend the questionnaire, Patients having co-morbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fatigue assessment Scale (FAS) to measure Fatigue, Post-COVID functional Status Scale (PCFS) to measure Functional Status and EQ-5D-5L to measure health-related quality of life |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare perception of fatigue, functional status and health related quality of life using the relevant scales |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2021 |
| Date of Study Completion (India) |
16/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Over the last few months, humanity has been facing a global pandemic, caused by the novel coronavirus SARS-Cov-2. Millions of people around the world have tested positive in the RT-PCR tests. Several deaths have also been recorded. Patients testing positive greatly vary in symptoms and based on the set guidelines have been hospitalized or have been asked to be home quarantined. According to some studies even when these patients test negative in RT-PCR test fatigue is one of the most persistent post-covid symptoms. Post-covid persistent symptoms like fatigue have a direct impact on the functional status and quality of life of the patients. Our study will assess the perception of fatigue, functional status and health-related quality of life amongst post-covid hospitalized and home quarantined patients. Our study is a cross-sectional observational study and a telesurvey will be used to compile the data. Permission to conduct this study has been sought from Departmental Review Board (DRB(PT)/2021/002) Post-Covid patients who would be willing to participate in the study would be contacted and a few relevant questions would be asked. The questionnaire would include the Fatigue assessment scale (FAS) to know the perception of fatigue, EQ-5D-5L scale to know the perception of health-related quality of life, and finally Post-covid functional status scale (PCFS) to know the perception of the functional status of the participants based on the inclusion criteria. After all the collected data is compiled a systematic statistical analysis would be done. |