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

This study has been terminated.
(Low enrollment)
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01513031
First received: January 16, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Atrial Fibrillation
Medication Adherence
Other: Education and telephone follow-up
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Creighton University:

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


Enrollment: 9
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prescribed a new anti-arrhythmic medication for atrial fibrillation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01513031     History of Changes
Other Study ID Numbers: DRONE_L_06034, 11-16223
Study First Received: January 16, 2012
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 23, 2014