| CTRI Number |
CTRI/2022/03/040816 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
19/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Quality of life after covid infection , A followup study |
|
Scientific Title of Study
|
Assessment of Quality of life in follow-up patients with COVID-19 pneumonia |
| Trial Acronym |
QOL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rupali patnaik |
| Designation |
associate professor |
| Affiliation |
IMS & SUM hospital |
| Address |
Dept of critical care medicine
IMS and SUM hospital
Bhubaneshwar
odisha
--
Khordha
ORISSA
751003
India |
| Phone |
8921354225 |
| Fax |
|
| Email |
rupali.patnaik87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tatikonda Chandra Mouli |
| Designation |
DM resident in critical care |
| Affiliation |
IMS & SUM hospital |
| Address |
Dept of critical care medicine
IMS and SUM hospital
Bhubaneshwar
odisha
..
Khordha
ORISSA
751003
India |
| Phone |
9591654666 |
| Fax |
|
| Email |
chandradasavatar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tatikonda Chandra Mouli |
| Designation |
DM resident in critical care |
| Affiliation |
IMS & SUM hospital |
| Address |
Dept of critical care medicine
IMS and SUM hospital
Bhubaneshwar
odisha
..
Khordha
ORISSA
751003
India |
| Phone |
9591654666 |
| Fax |
|
| Email |
chandradasavatar@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS & SUM hospital
SOA university
bhubaneshwar
Odisha
751003 |
|
|
Primary Sponsor
|
| Name |
IMS SUM hospital |
| Address |
bhubaneshwar
odisha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Tatikonda chandra mouli |
IMS & SUM hospital |
Covid care centre
Department of CCM
campus 2
IMS and SUM hospital
bhubaneshwar
Khordha
ORISSA |
9591654666
chandradasavatar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
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, (2) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
1. Patients aged more than or equal to 18 years
2. Patients discharged with diagnosis of COVID-19 pneumonia
|
|
| ExclusionCriteria |
| Details |
not willing to disclose their quality of life |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of quality of life using SF-12 scale in COVID-19 pneumonia follow-up patients |
3 months, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mortality rate after discharge |
3month 6month 12 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "225"
Final Enrollment numbers achieved (India)="225" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/03/2022 |
| Date of Study Completion (India) |
20/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Adult patients more than 18 years after discharge with diagnosis of COVID pneumonia, will be assessed about their quality of life with telephonic interview 6 months after discharge. Assessment of quality of life will be done using SF-12 scale in COVID-19 pneumonia follow-up patients. Patients who have died while during follow up at 6 months, obviously their quality of life can not be assessed which is the primary outcome. But their data and records will be kept |