| CTRI Number |
CTRI/2025/09/095021 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mobile application based trial] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Mobile application to monitor the disease activity of Rheumatoid arthritis |
|
Scientific Title of Study
|
My Jionts- an app where doctor can monitor the disease activity in RA patients using SDAI & DAS 28 score and patient can assess disease activity periodically so as to detect early remission |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASHA GOPAN G P |
| Designation |
Post graduate,General Medicine |
| Affiliation |
Saveetha Medical College & Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9074067968 |
| Fax |
|
| Email |
asha1193gopan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ananthakumar P K |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
TAMIL NADU -602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9620916481 |
| Fax |
|
| Email |
ananthakumarpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ananthakumar P K |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
TAMIL NADU -602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9620916481 |
| Fax |
|
| Email |
ananthakumarpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
TAMIL NADU -602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha Medial College and Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
TAMIL NADU -602105 |
| 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 |
| DrAsha Gopan G P |
Saveetha medical college and hospital |
Department of General Medicine, Saveetha Nagar,Thandalam,Chennai-602105,Tamil nadu
Kancheepuram
TAMIL NADU |
9074067968
asha1193gopan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M05||Rheumatoid arthritis with rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
App based monitoring of disease activity in RA patients |
An app based monitoring system is used in addition to standard care in the interventional group..This app is mainly based on periodic inputs of data from both the patient as well as health care provider(treating physician /Rheumatologist).For patients, it offers resources like exercise videos, diet tips, and tools to track daily activities. Patients can upload test reports, ask their doctor questions, and get notifications when they receive a response.For doctors, the app simplifies patient care by allowing them to schedule appointments, manage prescriptions, and assess the severity of the disease using tools like SDAI and DAS28 CRP scores. This helps doctors monitor the patients progress and adjust treatment plans as needed |
| Comparator Agent |
Standard care of therapy |
Patients in the control arm get standard of care therapy according to established therapeutic guidline by the treating physician or rheumatologist on OPD basis.Laboratory data will be entered on a monthly basis. This Study will be conducted for a duration of six months.Voluntary surveys will be taken at beginning and end of the study period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Ability to consent
2. Patients diagnosed to have rheumatoid arthritis
3. Patients with access to a smart phone
4 . Understanding of either English or tamil language
|
|
| ExclusionCriteria |
| Details |
1. Inability to consent
2. Patients with cognitive disabilities
3. Participation in another interventional study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disease activity indices (DAS 28 CRP, SDAI) |
day 0,day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient/physician satisfaction, effect on adherence, whether app helps in monitoring between visits |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2025 |
| 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="0"
Months="6"
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
|
This study is done among patients with Rheumatoid arthritis coming to OPD of general medicine and Rheumatology in saveetha medical college and hospital. The patients recruited for the study are randomized into the control and intervention gropup.Patients in both groups receive standard guidline therapy.An App based monitoring sySterm is used in addition to standard Care in the intervention group .This app is mainly based on periodic inputs of data from both the patient as well as the healthcare provider (treating physician or rheumatologist).Laboratory data will be entered on a monthly basis. This Study will be conducted for a duration of six months.Voluntary surveys will be taken at beginning and end of the study period.The application serves as a comprehensive tool for managing rheumatoid arthritis by integrating validated disease activity assessment instruments such as the Simple Disease Activity Index (SDAI) and Disease Activity Score 28 (DAS28), enabling healthcare providers to accurately monitor patient conditions. It empowers patients to conduct self-assessments, track their symptoms, and share real-time data with their healthcare teams, facilitating timely treatment adjustments. The platform also offers a wide range of educational resources, including articles on disease management, self-care, nutrition, and exercise. Additionally, patients can upload relevant documents, schedule appointments, and communicate directly with their healthcare providers, fostering a collaborative and seamless care experience. By combining these features, the application aims to enhance treatment adherence, improve patient outcomes, and encourage active participation in health management |