Use of Electronic Personal Health Records to Improve Medication Adherence

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018197
• Other study ID #: PRC13-0806 ePHR AFib pilot
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2019
• Source: Parkview Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Medication Adherence

Intervention

Other:
• Medication 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.

Locations

Country	Name	City	State
United States	Parkview Research Center; Parkview Health	Fort Wayne	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Parkview Health	Centers for Medicare and Medicaid Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence evaluated through medication possession ratios		3 months during study
Secondary	Patient Engagement evaluated through Patient Activation Measure (PAM)		3 months during study
Secondary	Medication Knowledge evaluated through 5-question survey		3 months during study