Back to resultsDetermination of Rates and Reasons for Non-Adherence to Anti-Arrhythmic Therapy for Atrial Fibrillation
Primary Purpose
Atrial Fibrillation, Medication Adherence
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Education and telephone follow-up
Sponsored by
About this trial
This is an interventional health services research trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Anti-arrhythmic medication, Medication adherence
Eligibility Criteria
Inclusion Criteria:
- Prescribed a new anti-arrhythmic medication for atrial fibrillation
Sites / Locations
- Bryan LGH
- Alegent Health Bergan Mercy Medical Center
- Creighton University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Phone follow-up
Arm Description
All study participants will be receiving education and monthly telephone follow-up.
Outcomes
Primary Outcome Measures
Adherence to anti-arrhythmic medication
Assessing whether patients stop taking anti-arrhythmic medication without instruction to do so by their physician.
Secondary Outcome Measures
Full Information
NCT ID
NCT01513031
First Posted
January 16, 2012
Last Updated
June 28, 2012
Sponsor
Creighton University
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT01513031
Brief Title
Determination of Rates and Reasons for Non-Adherence to Anti-Arrhythmic Therapy for Atrial Fibrillation
Official Title
Pilot Project to Determine Rates and Reasons for Non-Adherence in Patients Receiving Chronic Oral Antiarrhythmic Therapy for Atrial Fibrillation in the State of Nebraska
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if follow-up by a pharmacist over the telephone improves adherence and short term clinical outcomes in the patient with atrial fibrillation prescribed an oral anti-arrhythmic medication. This study will also identify the reasons people stop taking their anti-arrhythmic therapy. A pharmacist will provide medication counseling about their anti-arrhythmic therapy, then will follow-up by telephone on a monthly basis to assess adherence over one year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Medication Adherence
Keywords
Atrial fibrillation, Anti-arrhythmic medication, Medication adherence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phone follow-up
Arm Type
Experimental
Arm Description
All study participants will be receiving education and monthly telephone follow-up.
Intervention Type
Other
Intervention Name(s)
Education and telephone follow-up
Intervention Description
Education related to anti-arrhythmic therapy and monthly telephone follow-up to assess adherence to medication.
Primary Outcome Measure Information:
Title
Adherence to anti-arrhythmic medication
Description
Assessing whether patients stop taking anti-arrhythmic medication without instruction to do so by their physician.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prescribed a new anti-arrhythmic medication for atrial fibrillation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Hilleman, PharmD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bryan LGH
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Alegent Health Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Determination of Rates and Reasons for Non-Adherence to Anti-Arrhythmic Therapy for Atrial Fibrillation
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