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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01513031
• Other study ID #: DRONE_L_06034
• Secondary ID: 11-16223
• Status: Terminated
• Phase: Phase 4
• First received: January 16, 2012
• Last updated: June 28, 2012
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Prescribed a new anti-arrhythmic medication for atrial fibrillation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Atrial Fibrillation
• Medication Adherence

Intervention

Other:
• Education and telephone follow-up
Education related to anti-arrhythmic therapy and monthly telephone follow-up to assess adherence to medication.

Locations

Country	Name	City	State
United States	Bryan LGH	Lincoln	Nebraska
United States	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to anti-arrhythmic medication	Assessing whether patients stop taking anti-arrhythmic medication without instruction to do so by their physician.	1 year	Yes