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临床试验/NCT03254745
NCT03254745已完成不适用

Evaluation of Pharmacist's Intervention in Improving Treatment Outcomes of Rheumatoid Arthritis Patients in Karachi, Pakistan: The Pharmacist Assisted Care Trial for Rheumatoid Arthritis Patients (PACTRA)

Universiti Sains Malaysia2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Disease Activity

研究概览

简要总结

Rheumatoid arthritis is an auto-immune disorders that mainly affects the joints. It may also affect other organs of the body such as skin, eyes, lungs and heart. The immune system of the body attacks the lining of the joint that results in erosion and joint deformity. This condition if untreated may lead to disability. RA is managed by medications known as disease modifying anti rheumatic drugs (DMARDs) as well as physical therapy. Dietary and lifestyle modification may also ease the condition.

详细描述

One of the major problems in managing RA is adherence to rehabilitation and medication. Studies report low adherence to medication among patients of RA. Certain barriers to rehabilitation also exists which may include exhaustive treatment attendance, time management and direct costs. Patient intentionally make decisions of non adherence to their prescribed rehabilitation schedule and medication regimen. This may be due to suffering from adverse drug reactions (ADRs) of medications, excessive pain arising from physical therapy and/or out-of-pocket costs.

Pharmacists have the potential to improve the patient's clinical, humanistic and economic outcomes in rheumatoid arthritis by providing pharmaceutical care. This can be executed by:

  1. Resolving drug related problems and managing drug therapy
  2. Management of modifiable risk factors such as weight
  3. Recommending dietary and lifestyle changes
  4. Providing patient counseling, disease education and medication advice
  5. Reducing the out-of-pocket costs
  6. Improve overall well being and quality of life

Evidence from the past indicates a varying prevalence of RA in Pakistan. Figures for prevalence of RA varied geographically as literature reported a prevalence of 0.142% to 5.5% in the southern and northern region of Pakistan respectively. Recently, a study conducted in a tertiary care unit in the city of Karachi located in southern region reported a figure of 633 (12.9%) for RA patients out of total 4900 patients who visited rheumatology clinic in the hospital. It highlighted that disease burden in this region has dramatically increased.

Most Pakistani patients lack adequate disease knowledge and awareness regarding RA. Moreover, patients in Pakistan have to pay direct medical cost in most of the cases. In the past, studies have highlighted that Pakistani patients view costs per session and treatment attendance as major barriers to undergo physical therapy sessions for rheumatological disorders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Investigator will be blinded. Outcome assessor would be blinded. Patients in the control group would be blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Out-patients with established diagnosis of rheumatoid arthritis over 3 months.
  • Participants who are willing to participate in the study.

排除标准

  • Patients with no rheumatoid arthritis.
  • Patients currently undergoing surgery or had previous history of surgery.
  • Patients with more than 3 comorbidities.
  • Patients who are not willing to participate.
  • In-patients will not be included.

结局指标

主要结局

Disease Activity

时间窗: Week 12 from baseline

The disease activity was assessed by disease activity score (DAS) also known as DAS - 28 score.

Disease knowledge

时间窗: Week 12 from baseline

Knowledge about rheumatoid arthritis

Medication Adherence

时间窗: Week 12 from baseline

Patients' adherence to their medications

Adverse events

时间窗: Week 12 from baseline

The adverse events were assessed directly through patients' medical history that was available in hospital database.

Health Related Quality of Life (HR-QOL)

时间窗: Week 12 from baseline

Rheumatoid arthritis patients' health related quality of life

Direct Cost of treatment

时间窗: Week 12 from baseline

Direct cost of rheumatoid arthritis treatment on patient's pocket

Treatment Adherence

时间窗: Week 12 from baseline

Patients' adherence to their rehabilitation

次要结局

  • Patient satisfaction(At Week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Atta Abbas Naqvi

Atta Abbas Naqvi

Universiti Sains Malaysia

研究点 (2)

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