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临床试验/NCT03024307
NCT03024307已完成不适用

Evaluation of an Outpatient Pharmacy Clinical Services Program on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2017年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
242
试验地点
1
主要终点
Medication adherence in the OPCSP program compared with usual care

研究概览

简要总结

This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The purpose of this study is to evaluate:

  1. rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
  2. total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.

详细描述

This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.Three types of rheumatic diseases were included in the study, Systemic lupus erythematosus (SLE), Ankylosing spondylitis (AS), and Rheumatoid Arthritis(RA). The purpose of this study is to evaluate:

  1. rates of medication adherence in the OPCSP program compared with usual care in an integrated health care system.
  2. total direct costs and clinical outcomes in the OPCSP program compared with usual care in an integrated health care system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Willingness of the subject to participate in the study, proven by signing the informed consent;
  • •Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
  • •Patients fulfilled the American College of Rheumatology criteria for RA and AS;

排除标准

  • •Patients who are unwilling to sign the inform consent;
  • •Pregnancy or lactation

研究组 & 干预措施

usual care only

No Intervention

Patients were provided with usual care.

Involvement of pharmacists in improving medication

Experimental

Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up

干预措施: pharmacists involved OPCSP (Other)

结局指标

主要结局

Medication adherence in the OPCSP program compared with usual care

时间窗: 12 months

Medication adherence would be evaluated by the questionnaire survey, CQR19. Scores of medication adherence would be calculated.

次要结局

  • Changes in medical outcomes from baseline at each visit by EQ5D-3L(12 months)
  • changes in direct costs from baseline at each visit(12 months)

研究者

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

Ting Li

Doctor

RenJi Hospital

研究点 (1)

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