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Use of Electronic Personal Health Records to Improve Medication Adherence

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03018197
Enrollment
90
Registered
2017-01-11
Start date
2014-02-28
Completion date
2014-07-31
Last updated
2019-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Medication Adherence

Keywords

Personal Health Record, Medication Knowledge, Anticoagulants, Patient Engagement

Brief summary

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.

Detailed description

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.

Interventions

OTHERMedication Education

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.

Sponsors

Centers for Medicare and Medicaid Services
CollaboratorFED
Parkview Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Medication Adherence evaluated through medication possession ratios3 months during study

Secondary

MeasureTime frame
Patient Engagement evaluated through Patient Activation Measure (PAM)3 months during study
Medication Knowledge evaluated through 5-question survey3 months during study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026