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Determination of Rates and Reasons for Non-Adherence to Anti-Arrhythmic Therapy for Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT01513031
Recruitment Status : Terminated (Low enrollment)
First Posted : January 20, 2012
Last Update Posted : July 2, 2012
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Creighton University

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Medication Adherence Other: Education and telephone follow-up Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : January 2012
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Phone follow-up
All study participants will be receiving education and monthly telephone follow-up.
Other: Education and telephone follow-up
Education related to anti-arrhythmic therapy and monthly telephone follow-up to assess adherence to medication.



Primary Outcome Measures :
  1. Adherence to anti-arrhythmic medication [ Time Frame: 1 year ]
    Assessing whether patients stop taking anti-arrhythmic medication without instruction to do so by their physician.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prescribed a new anti-arrhythmic medication for atrial fibrillation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513031


Locations
United States, Nebraska
Bryan LGH
Lincoln, Nebraska, United States, 68506
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Creighton University
Omaha, Nebraska, United States, 68178
Sponsors and Collaborators
Creighton University
Sanofi
Investigators
Principal Investigator: Dan Hilleman, PharmD Creighton University

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01513031     History of Changes
Other Study ID Numbers: DRONE_L_06034
11-16223 ( Other Identifier: Institutional Review Board )
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by Creighton University:
Atrial fibrillation
Anti-arrhythmic medication
Medication adherence

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents