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NCT Number: NCT02745236

The Effect of Nurse Practitioner Led-Care on Quality of Life in Patients With Atrial Fibrillation

Atrial fibrillation (AF) is the most common heart rhythm disease characterized by an irregular heart rhythm of the top part (atria) of the heart. It may cause unpleasant symptoms as well as increases the person's risk of stroke and heart failure. With an ageing population, increasing rates of AF and limited access to specialists, new methods of care, like nurse practitioners (NP) need to be assessed to meet patient specific needs and provide sustainable care.

The objective of the project is to evaluate the effect of Nurse Practitioner-led care in people with AF on their quality of life.

The Canadian Healthcare system is overwhelmed, with increasing costs and wait times. Contributing to these issues, is AF is the most common arrhythmia accompanied with costly complications including stroke and heart failure. Currently family or emergency room physicians ask general cardiologists or specialized cardiologists, to provide care to patients with AF. Unfortunately, there is limited access to their services. NP's are nurses who have taken extra education at University to treat patients and prescribe medications. This research project involves an NP who has specialized training in AF patient management.

By utilizing an NP to provide care for patients with AF, the investigators hope to improve patient's quality of life and satisfaction with care. This may also reduce complications of AF.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Behavior Cardiovascular Diseases Health Behavior Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mazankowski Alberta Heart Institution

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Documented non valvular atrial fibrillation
  • Able to provide informed consent
  • Able and willing to complete the study questionnaires on own or with assistance

Exclusion criteria

  • Referral is for atrioventricular node ablation or pulmonary vein isolation.
  • Patients who have failed antiarrhythmic medications
  • Patients with moderate to severe mitral or aortic valvular heart disease
  • Clinically unstable atrial fibrillation
  • Cannot or unwilling to attend follow-up appointments

Treatment and study plan

Nurse Practitioner Led-Care

Other

Diagnosis and treatment plan decisions will be determined by Nurse Practitioner Led-Care.

Other names: Intervention Arm

Cardiologist Led-Care

Other

Diagnosis and treatment plan decisions will be determined as per usual care by the Cardiologist

Other names: Control Arm

Primary outcomes

  1. Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups

    Time frame: At 6 months

Secondary outcomes

  1. Difference in change in EQ-5D scores between groups

    Time frame: At 6 months

  2. Difference in composite outcomes of death from cardiovascular causes, cardiovascular hospitalization and emergency room visits between groups

    Time frame: At 6 months

  3. Satisfaction with NP-led or cardiologist care as measured by the overall mean score of the Consultant Satisfaction Questionnaire (CSG).

    Time frame: At 6 months

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • University Hospital Foundation

Registry information

Official study title

The Effect of Nurse Practitioner-Led Care on Health Related Quality Of Life in Adult Patients With Atrial Fibrillation - A Randomized Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2016
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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