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临床试验/NCT02745236
NCT02745236已完成不适用

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

University of Alberta2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: At 6 months

次要结局

  • Difference in composite outcomes of death from cardiovascular causes, cardiovascular hospitalization and emergency room visits between groups(At 6 months)
  • Satisfaction with NP-led or cardiologist care as measured by the overall mean score of the Consultant Satisfaction Questionnaire (CSG).(At 6 months)
  • Difference in change in EQ-5D scores between groups(At 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcie Smigorowsky

PhD Student Faculty of Medicine and Dentistry

University of Alberta

研究点 (2)

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