Atrial FibrillationNCT03018197
Use of Electronic Personal Health Records to Improve Medication Adherence
A study testing Medication Education in people with Atrial Fibrillation and Medication Adherence, run by Parkview Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Medication Adherence
- What is being tested?
- Medication Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkview Research Center; Parkview Health
Fort Wayne, Indiana, 46845
About this study
Official title: The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Medication Adherence
- Being tested
- Medication Education
- Keywords
- Personal Health Record, Medication Knowledge, Anticoagulants, Patient Engagement
- Medical subject headings
- Atrial Fibrillation, Medication Adherence, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Medication Education | Experimental | Patients will receive training on the use of the personal health record and health education via the personal health record. Receives: Other: Medication Education |
| No Medication Education | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence evaluated through medication possession ratios
Measured: 3 months during study
Secondary outcomes (2)
Patient Engagement evaluated through Patient Activation Measure (PAM)
Measured: 3 months during study
Medication Knowledge evaluated through 5-question survey
Measured: 3 months during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkview Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Principal investigator, Michael Mirro, Parkview Health
- Investigators
- Michael Mirro, MD, Principal investigator, Parkview HealthOzlem Ersin, PhD, Principal investigator, Manchester University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018197
- Sponsor's protocol ID
- PRC13-0806 ePHR AFib pilot
- Status last verified
- Aug 2019
- First submitted
- 10 Jan 2017
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03018197
- Acronym / sponsor ID
- PRC13-0806 ePHR AFib pilot
- Conditions
- Atrial Fibrillation, Medication Adherence
- Keywords
- Personal Health Record, Medication Knowledge, Anticoagulants, Patient Engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Parkview HealthUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication Education | Experimental | Other: Medication EducationPatients will receive training on the use of the personal health record and health education via the personal health record. |
| No Medication Education | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication EducationMedication 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. | Other | Medication Education |
Primary outcome
Medication Adherence evaluated through medication possession ratios
Time frame: 3 months during study
2 secondary outcomes
Patient Engagement evaluated through Patient Activation Measure (PAM)
Time frame: 3 months during study
Medication Knowledge evaluated through 5-question survey
Time frame: 3 months during study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mirro, MD principal investigator
Parkview Health
Ozlem Ersin, PhD principal investigator
Manchester University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Education in people with Atrial Fibrillation and Medication Adherence, run by Parkview Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence evaluated through medication possession ratios (time frame: 3 months during study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.