| CTRI Number |
CTRI/2021/06/034340 [Registered on: 22/06/2021] Trial Registered Prospectively |
| Last Modified On: |
22/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Impact of reinforced awake proning on outcomes of COVID-19 pnemonia |
|
Scientific Title of Study
|
: A cluster randomized trial of a behaviour change intervention to better implement awake PROning manoeuvRE in COVID-19 patiEnts: ( PRO- RECOVER RCT) |
| Trial Acronym |
PRO- RECOVER RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya Umesh |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ST JOHNS MEDICAL COLLEGE AND HOSITAL |
| Address |
DEPARTMENT OF MEDICINE,
SJMCH,SARJAPUR ROAD,BANGALORE
DEPARTMENT OF MEDICINE,
SJMCH,SARJAPUR ROAD,BANGALORE
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065834 |
| Fax |
|
| Email |
drsoumya239@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya Umesh |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ST JOHNS MEDICAL COLLEGE AND HOSITAL |
| Address |
DEPARTMENT OF MEDICINE,
SJMCH,SARJAPUR ROAD,BANGALORE
DEPARTMENT OF MEDICINE,
SJMCH,SARJAPUR ROAD,BANGALORE
KARNATAKA
560034
India |
| Phone |
08022065834 |
| Fax |
|
| Email |
drsoumya239@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Umesh |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ST JOHNS MEDICAL COLLEGE AND HOSITAL |
| Address |
DEPARTMENT OF MEDICINE,
SJMCH,SARJAPUR ROAD,BANGALORE
DEPARTMENT OF MEDICINE,
SJMCH,SARJAPUR ROAD,BANGALORE
KARNATAKA
560034
India |
| Phone |
08022065834 |
| Fax |
|
| Email |
drsoumya239@gmail.com |
|
|
Source of Monetary or Material Support
|
| conducted in St Johns Medical College hospital. Infrastructure provided by the institution. |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Soumya |
ST JOHNS MEDICAL COLLEGE & HOSPITAL |
DEPARTMENT OF MEDICINE,
SJMCH
SARJAPUR ROAD,BANGALORE
Bangalore
KARNATAKA |
08022065834
drsoumya239@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,SJMCH |
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: J128||Other viral pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MULTI-COMPONENT,EDUCATIONAL INTERVENTION TO INDUCE BEHAVIOUR CHANGE |
EDUCATIONAL VIDEO, and leaflets that emphasise the importance of proning and ,TRACKERS TO RECORD TIME SPENT IN PRONE POSITION will be recorded daily for 7 days after recruitment or till discharge or occurrence of primary outcome which ever is earlier.Meanwhile all other treatment will be continued as per treating team which is as per institutional protocol. |
| Comparator Agent |
non interventional arm will receive standard of care as per institutional protocol. |
The treating team will continue the treatment as per
institutional protocol. They will be told to prone. However they will not receive the leaflet, video or tracker. Time spent in proning will be recorded on a daily basisFor 7 days. then they will be followed up till outcomes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
CONSENTING COVID 19 PATIENTS HOSPITALISED FOR MILD,MODERATE,SEVERE DISEASE |
|
| ExclusionCriteria |
| Details |
1. Inability to prone due to mechanical reasons
2. Heart failure NYHA Class 3/4
3. Decompensated Chronic Liver Disease with ascites
4. Presence of Pneumothorax or Pneumomediastinum
5. Critically Ill patients
6. Intubated patients
7. Morbid obesity
8. Pregnancy
9. Unstable Fractures
10. Acute Hypercapnic respiratory failure
11. Deep Vein Thrombosis (untreated<48hrs)
12. Other contraindications to Prone position documented in the Case record by the treating physician.
13. Intervention delayed beyond 48 hours of admission.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for invasive or non invasive ventilation or the occurence of death. |
At baseline, then daily till 7 days in both arms. After this all patients will be followed up till discharge or death. Final outcome will be recorded at that time. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resolution of hypoxia and the need for escalation of care. |
At baseline, and then daily for 7 days.
Secondary outcomes will be finally recorded at discharge or death |
|
|
Target Sample Size
|
Total Sample Size="302"
Sample Size from India="302"
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)
|
30/06/2021 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
With the ongoing COVID 19 pandemic a large number of patients are hospitalized with the need for supplemental O2. Awake proning has been shown to improve outcomes in patients. However patients find it difficult to comply especially as they do not have their family members with them. This study is being done to test the utility of education, reinforcement and trackers on the patient’s compliance to proning and in turn the effect on outcomes. |