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OpenTrials
Completed

NCT Number: NCT03018197

Use of Electronic Personal Health Records to Improve Medication Adherence

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkview Research Center; Parkview Health

Fort Wayne, Indiana, 46845, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Medication Education

Other

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.

Primary outcomes

  1. Medication Adherence evaluated through medication possession ratios

    Time frame: 3 months during study

Secondary outcomes

  1. Patient Engagement evaluated through Patient Activation Measure (PAM)

    Time frame: 3 months during study

  2. Medication Knowledge evaluated through 5-question survey

    Time frame: 3 months during study

Sponsors and collaborators

Lead sponsor

Parkview Health

Other

Collaborators

  • Centers for Medicare and Medicaid Services

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 11, 2017
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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