| CTRI Number |
CTRI/2020/11/028885 [Registered on: 04/11/2020] Trial Registered Prospectively |
| Last Modified On: |
20/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Frailty assessment for COVID-19 severity |
|
Scientific Title of Study
|
Frailty as a predictor of clinical severity in geriatric COVID-19 patients: A prospective observational study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yudhyavir Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
Room No- 322A, JPNATC,AIIMS
South West
DELHI
110029
India |
| Phone |
09811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yudhyavir Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
Room No- 322A, JPNATC,AIIMS
South
DELHI
110029
India |
| Phone |
09811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yudhyavir Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
Room No- 322A, JPNATC,AIIMS
South
DELHI
110029
India |
| Phone |
09811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Hospital |
| Address |
Ansari Nagar, New Delhi |
| 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 |
| yudhyavir singh |
COVID Centre |
322A,JPNATC, AIIMS, New Delhi
South
DELHI |
01126593212
yudhyavir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
65 years and above |
|
| ExclusionCriteria |
| Details |
1. Not giving consent
2. Trauma patients
3. Non-responsive patients
4. Intubated patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Admission frailty Scores
2. Mortality
|
At 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Compare the two frailty scores
2. Complications
3. Length of hospital stay
|
28 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
09/11/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In the last two decades there has been an increase in the number of geriatric populations throughout the world. Recently India has also acquired the label of “an aging nationâ€. According to the UNDP data, 7.7% of the Indian population is more than 60 years old and the number is expected to reach 324 million by 2050.This has led to the increase in the number of elederly population, that had added to the health burden.The older patients have decreased physiologic reserve and that makes them vulnerable to various illnesses. Until, recently frailty in particular, has become an area of increased interest. This is a multidimensional state of loss of physiologic reserves including energy, physical ability, cognition, and health that gives rise to vulnerability to poor health outcomes due to a decreased ability to withstand physiologic stress.There is consensus that frailty, as measured by any number of these metrics, is associated with adverse perioperative outcomes including major morbidity, mortality, and increased length of stay. The Initial observational studies by the Chinese CDC on COVID -19, from Wuhan published the mortality was high in old age patients, ranging from 8% to 14.8% indicating poor outcome in them. Besides this fatality rate was associated with comorbidities such as diabetes, hypertension, respiratory diseases and cancer. The various risk factors contributing to the death and mortality in old age COVID-19 patients need evaluation. Frailty can be one of the causes for the high mortality in elderly patients. No studies has used frailty as a predictor for the severity in COVID-19 patients. Therefore a study planned to predict the outcome in.COVID-19 patients by assessing the frailty by various scales. We hypothesised that frailty assessment will help in predicting the clinical severity of COVID-19 patients and outcome. The study will be conducted on COVID positive patients who will be receiving treatment according to the AIIMS, guideline at COVID centre. After obtaining institutional ethical clearance patients will be recruited and the consent will be taken. Patients will be assessed and screened for frailty at the time of admission in the hospital. The admission frailty scores will be calculated by the two different scales that are: the CFS and mFI-5 scores. Assessors may not be present daily and data will be collected on days the patient will be followed up. Patients will be clinical follow up for the outcome and severity. Patients will be followed till it is discharged or any adverse outcomes will be noted over 28 days. All the in hospital complications, the total length of stay including ward and ICU will be noted down. Also the morbid condition and the multiple drugs, if the patient is taking them will be written. |