| CTRI Number |
CTRI/2020/05/025495 [Registered on: 31/05/2020] Trial Registered Prospectively |
| Last Modified On: |
30/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Screening of healthcare workers, Doctors and Nurses working in Covid-19 wards using a continous wearable watch device |
|
Scientific Title of Study
|
Continous wearable device based Monitoring of Healthcare Professionals supporting Covid-19 patients for early screening of Covid-19 related symptoms |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kayapanda Mandanna |
| Designation |
Director, Cardiac Surgery |
| Affiliation |
Fortis hospitals , Kolkata |
| Address |
Fortis Hospital,Room 417
Department of Cardiac Surgery,
730, Anandpur,
Kolkata
Kolkata
WEST BENGAL
700107
India |
| Phone |
09831112359 |
| Fax |
|
| Email |
kmmandana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kayapanda Mandanna |
| Designation |
Director, Cardiac Surgery |
| Affiliation |
Fortis hospitals , Kolkata |
| Address |
Fortis Hospital,Room 417
Department of Cardiac Surgery
730, Anandpur
Kolkata
Kolkata
WEST BENGAL
700107
India |
| Phone |
09831112359 |
| Fax |
|
| Email |
kmmandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kayapanda Mandanna |
| Designation |
Director, Cardiac Surgery |
| Affiliation |
Fortis hospitals , Kolkata |
| Address |
Fortis hospital,Room 417,
Department of Cardiac Surgery,
730, Anandpur,
Kolkata
Kolkata
WEST BENGAL
700107
India |
| Phone |
09831112359 |
| Fax |
|
| Email |
kmmandana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata consultancy services , Innovation Labs , Kolkata |
|
|
Primary Sponsor
|
| Name |
Tata Consultancy Services India |
| Address |
TCS , Innovation Labs,
3B, Ecospace, Rajarhat,
Newtown , KOLKATA |
| Type of Sponsor |
Research institution |
|
|
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 Kayapanda Mandanna |
Fortis Hospital |
Room 417, Department of Cardiac Surgery, 730, Anandpur, Kolkata
South Twentyfour Parganas
WEST BENGAL |
09831112359
kmmandana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Fortis hospitals Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Doctors and Nurses only, in Covid exposed wards / ICU |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All healthcare workers , assigned to Covid ward / ICU duties, includes Doctors and Nurses |
|
| ExclusionCriteria |
| Details |
Persons not involved in Covid -19 care wards/ICU |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fortis will distribute the wearable device Watch called ( Empatica E4 ) provided by TCS to consenting volunteers. The volunteer will wear the watch continously for 2 weeks , wherein the following metadata will be recorded. Heart rate, Spo2, Body temperature, height, weight, Blood pressure( recorded manually ), will be recorded against the USER ID provided to TCS. |
Data to be analysed at Baseline, at 2 weeks, at 4 weeks and at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Can be used extensively as a wearable device ,for healthcare workers in Covid exposed settings and also persons in Quarentine , ...who can be detected or diagnosed early for treatment if Metadata / algorithm suggests, that the person has been exposed to the Covid-19 virus. |
Baseline, at 2 weeks, at 4 weeks and at 6 weeks |
|
|
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)
|
10/06/2020 |
| 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="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This observational study called, Continous Wearable device based Monitoring of healthcare professionals supporting Covid -19 patients for early screening of Covid -19 related symptoms. This study is a prototype to test and predict with the Metadata collected by a wearable device ( Empatica E 4 ) by consenting doctors and nurses, who are directly involved in the treatment of covid 19 patients in ICU or Wards. The study is basically to detect early warning for these healthcare workers , by means of information collected by the watches . The watches will record continously the PPG ( photoplythsmography ), GSR, Skin temperature, Heart rate, Respiratory rate and Accelerometer data. As we know the Covid -19 patients are Happily Hypoxic with saturations ranging from 85% to 95% in room air, but still are asymptomatic. The idea is to capture the various parameter ( Meta data )and the Spo2 of our healthcare workers every 24 hours ( by downloading from the watch all data ), and analyzing in a software to look at the trend to see for temperature raise ,heart rate raise or Spo2 drop , in these individuals who are in Covid ward or ICU , looking after the patients,. By looking at the Metadata , we are looking at fore Warning the doctors or nurses, regarding their deteriorating health ,while serving in these Covid wards . These people can be now be further evaluated , with a high suspicion to the viral disease and quarentined thereafter. These wearable devices can also be used on people ,who are on home or Institutuional Quarentine for 14 or more days. The study will be conducted in over 30 individuals , over a period of 1 month , in one hospital, which is treating Covid patients . The Ethics approval has been obtained from Fortis hospital, kolkata vide reg no,. ECR/240/INST/WB/2013/RR-19 DATED 19TH MAY 2020 |