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临床试验/NCT05810896
NCT05810896已完成不适用

Improving Outpatient Comprehensive Atrial Fibrillation Care Across Central North Carolina Through Direct Primary Care and Patient Engagement

University of North Carolina, Chapel Hill6 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2023年4月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
6
主要终点
Change Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) Score

研究概览

简要总结

The goal of this study is to determine the effectiveness of a direct-to-patient virtual education program ("AF at Home") for adults with atrial fibrillation (AF). The main questions this study aims to answer are:

  1. Will participants in the educational program have improvement in quality of life, self-monitoring, and self-management strategies after program completion?
  2. Will patient level quality of AF care improve for participants in the educational program?

Participants will be asked to:

  • Participate in six hours of virtual education sessions over three weeks via Zoom.
  • Complete online questionnaires before the program starts and after its completion.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • Patient with diagnosis of non-valvular or valvular atrial fibrillation
  • Age >/= 18

排除标准

  • Unable to provide informed consent
  • Incarcerated patient

研究组 & 干预措施

AF at Home

Experimental

All recruited participants will participate in the AF at Home educational intervention.

干预措施: AF at Home (Other)

结局指标

主要结局

Change Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) Score

时间窗: Baseline and 3 weeks

The AFEQT questionnaire is a validated tool used to measure self-reported quality of life specifically for patients with atrial fibrillation. The questionnaire includes 20 questions measured on a 7-point Likert scale (1= not at all to 7=extremely) with 3 subcategories. The subcategories include symptoms (questions 1-4), daily activities (questions 5-12), and treatment concerns (questions 13-18). Scoring provides an overall AFEQT score (based on questions 1-18), and a treatment satisfaction score (based on questions 19-20). Treatment satisfaction scores are not included in the overall AFEQT score. Overall or subcategory scores range from 0-100. A score of 100 corresponds to no disability, and a score of 0 corresponds to total disability.

次要结局

  • Change in Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Global Pain Intensity Scores(Baseline and 3 weeks)
  • Change in Cardiac Anxiety Questionnaire (CAQ)(Baseline and 3 weeks)
  • Number of Patients Prescribed Appropriate Anticoagulation(Baseline and 1-year post intervention session 6)
  • Number of Patients Prescribed Antiplatelet Therapy for AF Stroke Risk Reduction(Baseline and 1-year post intervention session 6)
  • Number of Patients with Achievement of Blood Pressure at Target(Baseline and 1-year post intervention session 6)
  • Number of Patients with Achievement of Heart Rate Target(Baseline and 1-year post intervention session 6)
  • Number of Patients Prescribed Rhythm Controlling Medications(Baseline and 1-year post intervention session 6)
  • Number of Emergency Department Visits or Hospital Admissions for AF or Stroke (Healthcare Utilization)(Baseline and 1-year post intervention session 6)
  • Change in Confidence in Atrial Fibrillation Management (CALM) Scale(Baseline and 3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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