| CTRI Number |
CTRI/2025/07/091183 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Tailored Education System] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can a Personalized Education Program Help People with Rheumatoid Arthritis Take Their Medicines Better and Feel Healthier? |
|
Scientific Title of Study
|
Impact of a Tailored Multimodal Educational Intervention on Medication Adherence and Rheumatoid Arthritis Disease Activity: A Randomized, Parallel-Group, Interventional Study. |
| 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 Chaitali A Chindhalore |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
AIIMS Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108
Nagpur MAHARASHTRA 441108 India |
| Phone |
8999905594 |
| Fax |
|
| Email |
drchaitali@aiimsnagpur.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Sanjaya Dhal |
| Designation |
Msc Student |
| Affiliation |
AIIMS Nagpur |
| Address |
AIIMS Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108
Nagpur MAHARASHTRA 441108 India |
| Phone |
7978692609 |
| Fax |
|
| Email |
sanjaydhal2017@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sanjaya Dhal |
| Designation |
Msc Student |
| Affiliation |
AIIMS Nagpur |
| Address |
AIIMS Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108
Nagpur MAHARASHTRA 441108 India |
| Phone |
7978692609 |
| Fax |
|
| Email |
sanjaydhal2017@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Chaitali A Chindhalore |
| Address |
AIIMS Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Chaitali Chindhalore |
All India Institute of Medical Sciences |
Department of pharmacology in collaboration with Department of Rheumatology and General medicine AIIMS Nagpur MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108 Nagpur MAHARASHTRA |
8999905594
drchaitali@aiimsnagpur.edu.in |
|
|
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: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Routine Care |
Participants in the control group will receive the standard of care routinely provided to patients with Rheumatoid Arthritis in the outpatient department. This includes:
Physician-led clinical evaluation and medication prescription as per standard treatment guidelines.
Brief, unstructured verbal instructions during clinical visits.
No additional educational material, structured counseling sessions, or digital reminders will be provided.
No reinforcement or follow-up educational intervention will be applied during the study period. |
| Intervention |
Tailored Multimodal Educational Intervention on Medication Adherence and Rheumatoid Arthritis Disease Activity |
The intervention group will receive a tailored multimodal education program focused on improving medication adherence. One-on-one counselling sessions are tailored to each patients needs, focusing on understanding their treatment regimen, addressing misconceptions, and building motivation for adherence. Flyers and visual aids are shared to reinforce key messages. Through weekly telephonic reminders/conversations, will track adherence and address barriers in real-time. This comprehensive approach ensures personalized support, effective communication, and ongoing monitoring to enhance treatment adherence. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of rheumatoid arthritis according to the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria
Patients of an either gender with age more than 18 years
On stable dose of anti-rheumatoid medication for 4 weeks prior to enrolment in study
Ability to provide written informed consent.
Willingness to participate in educational sessions and adhere to study protocols.
Proficiency in the local language or English to understand educational materials.
|
|
| ExclusionCriteria |
| Details |
I. Severe cognitive impairment or psychiatric conditions that may interfere with study participation.
II. Patient suffering from severe chronic illness which may affect the disease outcome/compliance.
III. Concurrent participation in other interventional studies related to RA management.
IV. Pregnancy or breastfeeding, as these conditions may affect medication regimens and disease activity.
V. History of non-adherence to medical appointments or inability to attend follow-up visits |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean changes in CQR 19 score at week 12 in both groups. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in CQR 19 score from baseline to week 6, and week 12 in both groups. |
0 to 6 weeks and 12 weeks |
| Change in Disease activity score (DAS) from baseline to week 6 and week 12 in both the groups. |
12 weeks |
| Proportion of patients achieving remission in both the groups |
12 weeks |
| To study the impact of various sociodemographic variables along with medication adherence on disease activity |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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)
|
01/09/2025 |
| 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
|
This randomized, parallel-group interventional study is designed to assess the impact of a tailored multimodal educational intervention on medication adherence and disease activity in patients with Rheumatoid Arthritis (RA). RA is a chronic autoimmune disorder that requires long-term pharmacological management. Despite the availability of effective treatments, poor medication adherence remains one of the most significant challenges in achieving optimal disease control. Non-adherence contributes to disease progression, increased disability, healthcare burden, and decreased quality of life. This study seeks to evaluate whether personalized education—delivered through multiple formats—can enhance adherence and improve patient outcomes in a real-world outpatient setting. The intervention will consist of educational videos in local language, individualized counseling sessions, and digital reminders via SMS or WhatsApp. The educational content will be customized to address common barriers to adherence, such as fear of side effects, lack of understanding of disease mechanisms, and misconceptions about long-term therapy. The control group will receive standard care and routine follow-up, without structured education. Eligible participants aged 18 years and above with a confirmed diagnosis of RA and on stable disease-modifying antirheumatic drugs (DMARDs) for at least one month will be enrolled from the Rheumatology OPD of AIIMS, Nagpur. After obtaining informed consent, participants will be randomized into two groups using computer-generated randomization. The educational intervention will be delivered at baseline, followed by reinforcement during monthly follow-up visits for a total duration of three months. Medication adherence will be assessed using the CQR-19 questionnaire at baseline and follow-up. Disease activity will be evaluated using the Disease Activity Score 28 (DAS28), which includes tender joint count, swollen joint count, ESR/CRP, and patient global assessment. In addition to primary outcomes of adherence and disease activity, secondary outcomes such as patient satisfaction, perceived treatment benefit, and self-reported barriers to adherence will be analyzed. Data will be statistically evaluated using appropriate tests, with p<0.05 considered significant.
This study has the potential to generate practical evidence on the effectiveness of structured educational tools in improving adherence among RA patients. If successful, the intervention model could be adapted into routine clinical practice and extended to other chronic diseases requiring long-term therapy. By empowering patients through knowledge, the study hopes to bridge the gap between prescription and consumption—transforming treatment compliance from a burden into a behavior. |