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

June 28, 2012 updated by: Creighton University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan LGH
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68178
        • Creighton University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prescribed a new anti-arrhythmic medication for atrial fibrillation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Collaborators

Sanofi

Investigators

  • Principal Investigator: Dan Hilleman, PharmD, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRONE_L_06034
  • 11-16223 (Other Identifier: Institutional Review Board)

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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