| CTRI Number |
CTRI/2025/10/095575 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Follow-up using outpatients department visits versus telemedicine visits in patients having active ulcerative colitis |
|
Scientific Title of Study
|
Comparison of Telemedicine vs Standard OPD follow up in flares of ulcerative colitis
- A patient preference randomised control trial. |
| Trial Acronym |
TOPIC-UC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Sharma |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room No 12 Nehru Hospital F Block Ground Floor Department of Gastroenterology PGIMER Chandigarh India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
917087008099 |
| Fax |
|
| Email |
docvishalsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal Sharma |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room No 12 Nehru Hospital F Block Ground Floor Department of Gastroenterology PGIMER Chandigarh India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
917087008099 |
| Fax |
|
| Email |
docvishalsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Agarwal |
| Designation |
Senior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room No 12 Nehru Hospital F Block Ground Floor Department of Gastroenterology Postgraduate Institute of Medical Education and Research Chandigarh India
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
918851608928 |
| Fax |
|
| Email |
abhianki2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh, India 160012 |
|
|
Primary Sponsor
|
| Name |
Director Postgraduate Institute of Medical Education and Research Chandigarh India |
| Address |
Kairon Block, PGIMER, Chandigarh, 160012 India |
| 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 |
| Dr Vishal Sharma |
Nehru Hospital |
Room No 12, F Block, Nehru Hospital, Postgraduate Institute of Medical Education and Research
Sector 12
Chandigarh 160012
Chandigarh
CHANDIGARH |
7087008099
docvishalsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K51||Ulcerative colitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard OPD consultation |
Patient preferring or randomized to this arm will be followed up with physical visits to the outpatients department for 14 weeks |
| Intervention |
Telemedicine consultation |
Patient preferring or randomized to this arm will be followed up using e-SANJEEVANI platform and advised through teleconsultation for 14 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
-Diagnosis of ulcerative colitis as per standard criteria (ECCO definition)
-Flares of ulcerative colitis diagnosed on basis of a modified Mayo Score of 5 or more including an endoscopy score of 2 or more
-Planned for induction therapy with steroids or advanced therapy
- Age between 18-75 years |
|
| ExclusionCriteria |
| Details |
- Crohn’s disease
- Pregnant women
- Severe comorbidity requiring follow-up
- Toxic megacolon
- Inability to comply with the study protocol or not willing to participate
6. Previous intestinal surgery |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cost of care inclusive of system and patient costs |
Completion of 14 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life score using EQ5D5L |
14 week |
| Disease related quality of life using SIBDQ |
14 week |
| Medication adherence using MARS5 |
14 week |
| Disease status active versus remission using partial Mayo Score |
14 week |
| Health care utilisation including hospitalisation or emergency visit or surgery |
14 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
14/10/2025 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
We plan to study the difference in manner of follow up of patients with a flare of ulcerative colitis. In this patient preference randomized trial patients diagnosed with a flare of ulcerative colitis on basis of complete Mayo Score will be offered a follow up either through outpatients department physical visits or teleconsults using the e Sanjeevani platform. Patients without a distinct preference for either of these modes of follow up will be randomized to one of the two arms. At end of 14 weeks comparison will be made in respect to costs of care, quality of life and medication adherence and disease activity. |