Use of Electronic Personal Health Records to Improve Medication Adherence

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Medication Adherence
• Interventions: Other: Medication Education

• Registration Number: NCT03018197
• Lead Sponsor: Parkview Health

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-11
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication Education	Medication Education	Patients will receive training on the use of the personal health record and health education via the personal health record.

Primary Outcome Measures

Name	Time	Method
Medication Adherence evaluated through medication possession ratios	3 months during study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Parkview Research Center; Parkview Health; 🇺🇸 Fort Wayne, Indiana, United States