此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Use of Electronic Personal Health Records to Improve Medication Adherence

2019年8月27日 更新者:Michael Mirro、Parkview Health

The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study

The purpose of this pilot study is to examine the use of a personal health record to improve medication adherence among patients with non-valvular atrial fibrillation taking dabigatran for primary prevention of embolic stroke.

研究概览

地位

完全的

详细说明

Three brief newsletters will be sent by the research staff to the study patients in the form of secure messages through their MyChart account. The newsletters will describe dabigatran tolerability, adverse effects, patient monitoring, warnings/precautions, and administration. Newsletters will be developed through a review of the FDA-approved prescribing information, general tertiary references, and a search of PubMed and drafted with guidance from a Drug Information Specialist at Manchester University College of Pharmacy as well as reviewed by the research staff.

Descriptive analysis will be used to analyze the survey to assess patient attitudes and beliefs about dabigatran and personal health records, as well as to assess the level of patient engagement. Difference-in-difference regression analysis will be used to evaluate the impact of the personal health record on dabigatran adherence by comparing the differences between times (pre-post) and interventions. Patient medication adherence will be correlated from the Pharmacy refill data to determine if the Intervention Group is more compliant than the Control Group. Multivariate analysis will be used to explore factors influencing personal health record use and dabigatran adherence.

研究类型

介入性

注册 (实际的)

90

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。

学习地点

    • Indiana
      • Fort Wayne、Indiana、美国、46845
        • Parkview Research Center; Parkview Health

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age ≥ 18 years
  • Patient of Parkview Physicians Group-Cardiology
  • Currently on dabigatran for non-valvular atrial fibrillation
  • Out-patient status
  • Ability to read and understand English
  • Access to the Internet
  • Ability to utilize the computer and Internet
  • Willingness to enroll in a MyChart account

Exclusion Criteria:

  • Physical or cognitive disability hindering provision of the informed consent process or performance of study tasks
  • Unable to physically or cognitively carry out the tasks necessary for activating and/or utilizing a personal health record
  • Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
  • Currently part of another study involving another type of personal health record (other than MyChart)

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

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Medication Education
Patients will receive training on the use of the personal health record and health education via the personal health record.
Medication education delivered via the personal health record (MyChart) pertinent to the anticoagulation medication dabigatran. Education newsletters will be sent at 4, 6, and 10 weeks post-enrollment.
无干预:No Medication Education
Patients will receive the current standard of care for the personal health record. Patients will not receive training on the use of the personal health record or health education via the personal health record.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Medication Adherence evaluated through medication possession ratios
大体时间:3 months during study
3 months during study

次要结果测量

结果测量
大体时间
Patient Engagement evaluated through Patient Activation Measure (PAM)
大体时间:3 months during study
3 months during study
Medication Knowledge evaluated through 5-question survey
大体时间:3 months during study
3 months during study

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。

调查人员

  • 首席研究员:Michael Mirro, MD、Parkview Health
  • 首席研究员:Ozlem Ersin, PhD、Manchester University College of Medicine

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

2014年2月1日

初级完成 (实际的)

2014年6月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2017年1月10日

首先提交符合 QC 标准的

2017年1月10日

首次发布 (估计)

2017年1月11日

研究记录更新

最后更新发布 (实际的)

2019年8月30日

上次提交的符合 QC 标准的更新

2019年8月27日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • PRC13-0806 ePHR AFib pilot

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

There is no plan to make individual participant data available.

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.

Medication Education的临床试验

3
订阅