| CTRI Number |
CTRI/2024/02/062362 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Disability assessment in Rheumatoid Arthritis Patients |
|
Scientific Title of Study
|
Disability in Rheumatoid Arthritis Patients: Patients perspective |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyaranjan Sethi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
All India Institute of Medical Sciences, Guwahati
Department of Physical Medicine and Rehabilitation
Room no 1075
Kamrup
ASSAM
781101
India |
| Phone |
8440963963 |
| Fax |
|
| Email |
satyaranjansethi@aiimsguwahati.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyaranjan Sethi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Guwahati |
| Address |
All India Institute of Medical Sciences, Guwahati
Department of Physical Medicine and Rehabilitation
Room No. 1075
Kamrup
ASSAM
781101
India |
| Phone |
8440963963 |
| Fax |
|
| Email |
satyaranjansethi@aiimsguwahati.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ebenezer C Kyndiah |
| Designation |
Senior Resident Doctor |
| Affiliation |
All India Institute of Medical Sciences, Guwahati |
| Address |
All India Institute of Medical Sciences, Guwahati
Department of Physical Medicine and Rehabilitation
room no. 1073
Kamrup
ASSAM
781101
India |
| Phone |
9436588334 |
| Fax |
|
| Email |
ebenezerkyndiah@gmaiul.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Guwahati |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Guwahati |
| Address |
All India Institute of Medical Sciences, Guwahati |
| 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 Satyaranjan Sethi |
All India Institute of Medical Sciences, Guwahati |
All India Institute of Medical Sciences Guwahati
Physical Medicine and Rehabilitation OPD
Room No. 1072,1073,1075,1076
Kamrup
ASSAM |
8440963963
satyaranjansethi@aiimsguwahati.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMSG IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D80-D89||Certain disorders involving the immune mechanism, |
|
|
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 |
patients with definite rheumatoid arthritis attending PMR OPD fulfilling 2010 ACR CRITERIA |
|
| ExclusionCriteria |
| Details |
patient aged below 18 years or more than 80 years
patient with mental illness or not giving consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of disability in terms of HAQDI Score |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| usefulness of Patient reported outcomes in disability assessment in RA patients |
baseline |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/02/2024 |
| 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="2"
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
|
The study aims to assess the disability in patients with rheumatoid arthritis attending PMR OPD in terms of HAQ DI score (Indian version) from the patients perspective using the Indian version of Health assessment questionnaire and disability index (HAQDI). |