| CTRI Number |
CTRI/2021/03/032348 [Registered on: 26/03/2021] Trial Registered Prospectively |
| Last Modified On: |
24/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Knowledge, Attitude and Practice towards COVID-19 |
|
Scientific Title of Study
|
Knowledge, Attitude and Practice towards COVID-19 in patients visiting Gastroenterology and Hepatology OPD
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shailesh |
| Designation |
Senior Research Fellow |
| Affiliation |
Kasturba Medical College |
| Address |
Dept. of Gastroenterology and Hepatology, Kasturba Medical College, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7406985507 |
| Fax |
|
| Email |
shailesh.kmc@leraner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiran Shetty |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College |
| Address |
Dept. of Gastroenterology and Hepatology, Kasturba Medical College, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8861920517 |
| Fax |
|
| Email |
shiran.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shailesh |
| Designation |
Senior Research Fellow |
| Affiliation |
Kasturba Medical College |
| Address |
Dept. of Gastroenterology and Hepatology, Kasturba Medical College, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7406985507 |
| Fax |
|
| Email |
shailesh.kmc@leraner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal 576104 |
|
|
Primary Sponsor
|
| Name |
Shailesh |
| Address |
Department of Gastroenterology and Hepatology, Kasturba Medical College, Mangalore |
| Type of Sponsor |
Other [Individual/ Investigator] |
|
|
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 Shiran Shetty A |
Kasturba Hospital (KMC), Manipal |
Department of
Gastroenterology, 4th
Floor, Smt.Sharada
Madhav Pai OPD,
Kasturba Hospital
(KMC), Manipal
Udupi
Udupi
KARNATAKA |
08202922197
shiran.shetty@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (2) ICD-10 Condition: K50-K52||Noninfective enteritis and colitis, (3) ICD-10 Condition: K55-K64||Other diseases of intestines, (4) ICD-10 Condition: K65-K68||Diseases of peritoneum and retroperitoneum, (5) ICD-10 Condition: K70-K77||Diseases of liver, (6) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (7) ICD-10 Condition: K90-K95||Other diseases of the digestive system, (8) 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 |
80.00 Year(s) |
| Gender |
Both |
| Details |
Aged 18 and above
Able to read and understand the content of the questionnaire (English or Kannada) |
|
| ExclusionCriteria |
| Details |
Not willing to give the consent / Unwilling to participate in the research.
Patients who do not read and understand Kannada or English.
Unable to fill in the questionnaire due to illness or other reasons.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess the knowledge about COVID-19 using the self-administered questionnaire (36 questions) |
Baseline only. No Follow-up |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="924"
Sample Size from India="924"
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)
|
29/03/2021 |
| 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="0"
Months="2"
Days="0" |
|
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)?
Response - NO
|
|
Brief Summary
|
The overall aim of the study is to assess the knowledge about COVID-19 using the self-administered questionnaire (36 questions). The scoring is recorded from 0 (no correct answers) to 36 (all correct answers), and the cut-off level for sufficient knowledge, attitude and practice will be derived from the average score of all the patients enrolled in the study. |