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临床试验/NCT03018197
NCT03018197已完成不适用

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

Parkview Health2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年2月1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
发起方
入组人数
90
试验地点
2
主要终点
Medication Adherence evaluated through medication possession ratios

研究概览

简要总结

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.

详细描述

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.

研究设计

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

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

  • 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

排除标准

  • 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)

研究组 & 干预措施

Medication Education

Experimental

Patients will receive training on the use of the personal health record and health education via the personal health record.

干预措施: Medication Education (Other)

No Medication Education

No Intervention

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.

结局指标

主要结局

Medication Adherence evaluated through medication possession ratios

时间窗: 3 months during study

次要结局

  • Medication Knowledge evaluated through 5-question survey(3 months during study)
  • Patient Engagement evaluated through Patient Activation Measure (PAM)(3 months during study)

研究者

发起方
Parkview Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Mirro

Chief Academic and Research Officer

Parkview Health

研究点 (2)

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