| CTRI Number |
CTRI/2024/09/073206 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
For Colonoscopy Examination How Social Media Awareness Will Benefit The Outcome |
|
Scientific Title of Study
|
Impact Of Patient Education Via Social Media For Better Colonoscopy Outcomes A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aron V Thomas |
| Designation |
DrNB Medical Gastroenterology Resident |
| Affiliation |
Believers Church Medical College |
| Address |
Department Of Medical Gastroenterology
Believers Church Medical College Hospital
Kallumpurathy Medayil
Vadakadathukavu P.O.
Adoor
Pathanamthitta
KERALA
691526
India |
| Phone |
9487015989 |
| Fax |
|
| Email |
draronkallumpurathu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak K Johnson |
| Designation |
Associate Professor |
| Affiliation |
Believers Church Medical College, Hospital |
| Address |
Department Of Medical Gastroenterology
Believers Church Medical College Hospital
St Thomas Nagar, Kuttapuzha P.O.
THIRUVALLA
Pathanamthitta
KERALA
689102
India |
| Phone |
9446182531 |
| Fax |
|
| Email |
johnson.deepak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aron V Thomas |
| Designation |
DrNB Medical Gastroenterology Resident |
| Affiliation |
BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL |
| Address |
DrNB Resident
Department of Medical Gastroenterology
Believers Church Medical College Hospital
St Thomas Nagar, Kuttapuzha P O, Thiruvalla
Kallumpurathu Medayil
Vadakadathukavu P.O.
Adoor
Pathanamthitta
KERALA
689103
India |
| Phone |
9487015989 |
| Fax |
|
| Email |
draronkallumpurathu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Believers Church Medical College Hospital
St Thomas Nagar, Kuttapuzha P O, Thiruvalla, Pathanamthitta District, Kerala, India
Pin 689103 |
|
|
Primary Sponsor
|
| Name |
Believers Church Medical College Hospital |
| Address |
Believers Church Medical College Hospital
St.Thomas Nagar, Kuttapuzha P.O. Thiruvalla, Kerala, India
Pin- 689103 |
| Type of Sponsor |
Private medical college |
|
|
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 Aron V Thomas |
Believers Church Medical College Hospital |
Department of Medical Gastroenterology, Endoscopy Room
St.Thomas Nagar
Kuttapuzha
Thiruvalla, India
Pin- 689103
Pathanamthitta
KERALA |
9487015989
draronkallumpurathu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Colonoscopy - conventional group |
This study will be compare two groups for whom colonoscopy is required. This group will receive colonoscopy instruction via conventional method only |
| Intervention |
Colonoscopy Video Group |
This study will be compare two groups for whom colonoscopy is required. This group will receive colonoscopy instruction via social media plus conventional method |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Outpatients aged 18 to 75 years who had indication for colonoscopic examination for screening or diagnostic purpose and who had not received a colonoscopy before will be enrolled and those who undergoing colonoscopy under local anaesthesia |
|
| ExclusionCriteria |
| Details |
Exclusion criteria includes 1) history of bowel surgery, especially colorectal surgery 2) severe comorbidities (eg: ascites, congestive heart failure, chronic renal failure and coronary artery disease within last 6 months) 3) Suspected IBD 4) unable to use social media and 5) Patient who have insufficient intellectual capacity to understand the survey process will also exclude |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO Assess Bowel Preparation Using BBPS |
10 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To test average score difference for two groups for- pain, anxiety, time to complete the procedure, time taken for recovery
To test if proportion of following parameters differs for two groups- willingness to repeat colonoscopy, adenoma detection rate, polyp detection rate, cecal intubation rate and sedation requirement |
1 year |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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)
|
11/09/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [draronkallumpurathu@gmail.com].
- For how long will this data be available start date provided 15-08-2024 and end date provided 15-08-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study conducting in Believers church medical college hospital among selected patients for whom colonoscopy is required. After obtaining written informed consent, patients will be divided into two groups by randomization, one group will receive colonoscopy instruction via social media (whast app) plus conventional method and other group via conventional method only. |