| CTRI Number |
CTRI/2024/04/066307 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study the challenges faced by researchers while using the patient-reported outcomes |
|
Scientific Title of Study
|
Investigators’ Insight into the Utilization, Adaptation, and Challenges of Patient-Reported Outcomes as a tool in Clinical Research in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithya Gogtay |
| Designation |
Professor and Head |
| Affiliation |
Seth G S medical College and KEM Hospital |
| Address |
Department of clinical Pharmacology, First floor, new MSB building, KEM hospital campus, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820495836 |
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya Gunjal |
| Designation |
Assistant Professor |
| Affiliation |
Seth G S medical College and KEM Hospital |
| Address |
Department of clinical Pharmacology, First floor, new MSB building, KEM hospital campus, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8097092722 |
| Fax |
|
| Email |
vijugmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananya Rakshit |
| Designation |
Senior Resident Doctor |
| Affiliation |
Seth G S medical College and KEM Hospital |
| Address |
Department of clinical Pharmacology, First floor, new MSB building, KEM hospital campus, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09774314774 |
| Fax |
|
| Email |
drananyarakshit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth GSMC and KEM Hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Seth GS Medical College and KEM Hospital, Acharya Donde marg, Parel, Mumbai, Maharashtra, India 400012 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ananya Rakshit |
Seth G. S Medical College and KEM hospital |
Department of clinical Pharmacology, First floor, new MSB building, KEM hospital campus, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA |
9774314774
drananyarakshit@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 |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Investigators involved in Clinical trial or any Clinical Research.
Have implemented electronic Patient-Reported Outcomes (PROs) in Clinical research
Willing to participate in this clinical research.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Challenges encountered by the investigators in technical aspects, communication, patient care, and safety reporting |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Utilization & integration of PROs in clinical research such as phase of clinical trial in which PROs were implemented, type of PROs used, training received for use of PROs [for study staff & participant
Benefits of ePROs: study team perspective, participant perspective, communication
Innovative methods of capturing & recording PROs
|
9 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/05/2024 |
| 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 - NO
|
|
Brief Summary
|
Study Title: Investigators’ Insight into the Utilization, Adaptation, and Challenges of Patient-Reported Outcomes as a Tool in Clinical Research in India Patient-reported outcomes (PROs) have become increasingly important in clinical trials as they incorporate valuable insights into the patient experience, symptoms, and overall quality of life. PROs encompass data directly reported by patients regarding their health condition without interpretation by healthcare professionals or anyone else. These measures can include symptoms, physical functioning, emotional well-being, and overall health-related quality of life. However, there are challenges associated with the use of PROs in clinical research. By understanding the challenges faced by investigators in using PROs, investigators can improve the patient experience within clinical research, leading to more patient-centric research practices. Hence, this present study aims to understand the challenges encountered by the investigators while using PROs in Clinical research. The survey will be conducted among the Investigators belonging to Medical colleges and Research Institutes across India. Potential participants will be identified through the Clinical Trial Registry of India website. “Patient-reported outcomes†“Electronic diary and “ediary†or “e-diary†will be used as keywords to search the trials which have Patient Reported Outcomes. Then the list of Principal Investigators [PIs] in that Clinical research will be prepared in Excel along with their contact details [email and mobile phones]. The questionnaire will be administered using a Google form. The link to the Google form will be sent via WhatsApp or email to Principal Investigators. Participation in this survey will be anonymous and all identification data will be kept confidential. |