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Impact of the Pharmaceutical Care on the Quality of Life in Patients With Chagas Heart Disease (ChagasCare)

2016年1月20日 更新者：Gilberto Marcelo Sperandio da Silva、Evandro Chagas Institute of Clinical Research

Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial

The investigators hypothesize that pharmaceutical care may constitute an important tool for the clinical management of these patients by improving their compliance to their treatment with consequent improvement in their quality of life by minimizing symptoms, and decreasing the number of hospital admissions and adverse drug reactions. Therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with Chagas heart disease complicated by heart failure.

Study Type: Interventional

Study Design: A total of 88 patients will be randomly assigned into two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care. Both groups will be subjected to a follow-up period of 12 months. The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes include drug-related problems and exercise tolerance measured by the standard six-minute walk test.

研究概览

地位

未知

条件

干预/治疗

研究类型

介入性

注册 (预期的)

88

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 巴西
      • Rio de Janeiro、巴西、21040360
        • 招聘中
        • Evandro Chagas Clinical Research Institute
        • 接触：
        • 首席研究员：
          • Gilberto M Sperandio da Silva, pharmaceutist

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 76年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • The proposed clinical trial will be conducted in volunteers with Chagas disease complicated by heart failure.
  • Subjects will include adults, men and women, racial or ethnic minorities.
  • Diagnosed by two distinct Chagas serology tests (indirect immunofluorescence and enzyme linked immunosorbent assay

Exclusion Criteria:

  • Patients with any of comorbidities that significantly affect the cardiac performance, such as coronary artery disease, moderate or severe heart valvular disease, left ventricular (LV) hypertrophy, congenital heart disease, or that limit their survival, such as malignant tumors and HIV, will be excluded from the study.
  • Patients will be also be excluded in case of failure to give informed consent, inability to perform 6 minute- walk test, significant cognitive impairment, or pregnancy.
  • Individuals who are participating in others intervention trials will also be excluded.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
其他：Standard Care
(1) group who will receive standard care
其他：Standard care
These patients will only receive standard care, with out follow-up by the pharmacist
其他：Standard Care and Pharmaceutical Care
(2) group who will receive standard care and pharmaceutical care
其他：Standard care and Pharmaceutical care
Pharmaceutical care is the direct interaction between the pharmacist and the drug's users in order to improve the therapeutic compliance among outpatients and promote adequate pharmacotherapeutic follow-up.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Quality of life.
大体时间：12 months
The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Evaluation of patient quality of life during follow up of two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care.
12 months

次要结果测量

结果测量
措施说明
大体时间
Incidence and types of drug-related problems
大体时间：12 months
To evaluate the drug-related problems based on the classification of the Brazilian Pharmaceutical Care Consensus. Evaluation of drug-related problems during follow up of two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care.
12 months
Physical functional capacity.
大体时间：12 months
All patients will have their physical functional capacity measured by the 6 minute-walk test (The patients will split in two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care). The test will be performed at the beginning of protocol and after 12 months of follow-up.
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Evandro Chagas Institute of Clinical Research

合作者

Alejandro Marcel Hasslocher Moreno, MD MSc PhD student
Andrea Costa, MD PhD
Andrea Silvestre de Sousa, MD PhD
Luiz Henrique C. Sangenis, MD MSc PhD student
Marcelo Teixeira de Holanda, MD MSc PhD student
Mayara da Costa Chambela - MSc student
Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD
Roberto Magalhães Saraiva, MD PhD
Sergio Salles Xavier, MD PhD

调查人员

  • 首席研究员：Gilberto M Silva, pharmaceutical、Evandro Chagas Clinical Research Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年10月1日

初级完成 (预期的)

2017年1月1日

研究完成 (预期的)

2017年3月1日

研究注册日期

首次提交

2012年3月23日

首先提交符合 QC 标准的

2012年3月28日

首次发布 (估计)

2012年3月29日

研究记录更新

最后更新发布 (估计)

2016年1月21日

上次提交的符合 QC 标准的更新

2016年1月20日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Chagas2303
  • 0034.0.009.000-11 (其他标识符：Research Ethics Committee of the Evandro Chagas Clinical Research Institute (IPEC))

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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医疗条件

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条件

罕见疾病

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地点

3
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