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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  
Self funded  
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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