Impact of Pharmacist Intervention on Therapeutic Outcome and Quality of Life of Patients Suffering Fom Rheumatoid Arthritis: A Randomized Open-Label Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- 1. To evaluate the impact of pharmacist intervention on disease activity using the DAS-28 (Disease Activity Score-28) and to assess the improvement in quality of life using SF 36 Scale in patients with RA.
研究概览
简要总结
1. Demographic and Clinical Data: Information on age, gender, social history, and concurrent medications will be collected from patient medical records.
2. Knowledge, Attitude, and Practice (KAP) Survey: A structured questionnaire will be used to assess participants’ knowledge, attitude, and practices related to RA and its management. The questionnaire will be administered at baseline and after the study period to measure any changes.
3. Efficacy Assessment: Clinical efficacy of DMARDs will be evaluated using the Disease Activity Score 28 (DAS-28) scale. The DAS-28 score will be recorded during the study period.
4. Quality of Life (QoL) Assessment: Quality of life will be assessed using the validated Health Assessment Questionnaire (HAQ) specific to RA, which will be administered at baseline and follow-up intervals to capture changes over time.
5. Drug Utilization Evaluation (DUE): Data on drug utilization patterns will be analyzed based on the WHO/INRUD prescribing indicators, including the average number of drugs per encounter, percentage of encounters with an antibiotic, and percentage of encounters with an injection.
6. Cost Analysis: Direct medical costs will be calculated, including the costs of DMARDs, hospitalizations, laboratory investigations, and other related medical expenses. Indirect costs, such as loss of productivity, will also be recorded and assessed through patient self-reports.
7. Results will be analyzed using suitable statistical test.
研究设计
- 研究类型
- Interventional
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults above 18years Patients receiving atleast one DMARD therapy Patients willing to participate and provide informed consent form.
排除标准
- •Patients with other autoimmune or inflammatory disorders.
- •Patients who are unable or unwilling to provide informed consent.
- •Pregnant or lactating women.
- •Psychiatric patients.
结局指标
主要结局
1. To evaluate the impact of pharmacist intervention on disease activity using the DAS-28 (Disease Activity Score-28) and to assess the improvement in quality of life using SF 36 Scale in patients with RA.
时间窗: 8 weeks
2. To perform a Cost-Effectiveness Analysis (CEA) of the pharmacist intervention versus standard care in the management of RA.
时间窗: 8 weeks
次要结局
- 1.To assess the Knowledge, Attitude, & Practice (KAP) of patients regarding their disease, treatment regimen, & lifestyle before & after pharmacist intervention.(2.To conduct Drug Utilization Evaluation (DUE) of medications prescribed to RA patients, analyzing patterns, rationality, & adherence.)
研究者
TRIVENI JAGADISH UMARANI
KLE Academy of Higher Education and Research Deemed to be University