Impact of a Tailored Multimodal Educational Intervention on Medication Adherence and Rheumatoid Arthritis Disease Activity: A Randomized, Parallel-Group, Interventional Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mean changes in CQR 19 score at week 12 in both groups.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •Severe cognitive impairment or psychiatric conditions that may interfere with study participation.
- •Patient suffering from severe chronic illness which may affect the disease outcome/compliance.
- •Concurrent participation in other interventional studies related to RA management.
- •Pregnancy or breastfeeding, as these conditions may affect medication regimens and disease activity.
- •History of non-adherence to medical appointments or inability to attend follow-up visits.
结局指标
主要结局
Mean changes in CQR 19 score at week 12 in both groups.
时间窗: 12 weeks
次要结局
- 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)
研究者
Dr Chaitali A Chindhalore
AIIMS Nagpur