- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03018197
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Fort Wayne, Indiana, United States, 46845
- Parkview Research Center; Parkview Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Medication Education
Patients will receive training on the use of the personal health record and health education via the personal health record.
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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.
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No Intervention: No Medication Education
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Medication Adherence evaluated through medication possession ratios
Time Frame: 3 months during study
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3 months during study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Engagement evaluated through Patient Activation Measure (PAM)
Time Frame: 3 months during study
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3 months during study
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Medication Knowledge evaluated through 5-question survey
Time Frame: 3 months during study
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3 months during study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Mirro, MD, Parkview Health
- Principal Investigator: Ozlem Ersin, PhD, Manchester University College of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRC13-0806 ePHR AFib pilot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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