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临床试验/NCT04462887
NCT04462887已完成不适用

Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest

University of Washington0 个研究点目标入组 168 人开始时间: 1998年1月1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
168
主要终点
SF-12 Short Form Health Survey (SF-12)

研究概览

简要总结

Determine the benefits of implantable cardioverter defibrillator (ICD) patients participating in a structured, 8-week educational telephone intervention delivered by expert cardiovascular nurses post-ICD. To determine if individuals participating in a post-hospital telephone nursing intervention would demonstrate (1) increased physical functioning, (2) increased psychological adjustment, (3) improved self-efficacy in managing the challenges of ICD recovery, and (4) lower levels of health care utilization over usual care at 1, 3, 6 and 12 months post-ICD implantation.

详细描述

The goal of the study was to determine if a short-term social cognitive theory intervention would improve physical functioning and enhance psychological adjustment after receiving a first time ICD. The central aim of this study was to determine if individuals participating in a telephone nursing intervention compared to usual care demonstrated (1) improved physical functioning, (2) improved psychological adjustment, 3) improved knowledge related to sudden cardiac arrest (SCA) and the ICD, and (4) lower levels of health care use over a 3-month period post-ICD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • the ability to read, speak, and write English,
  • having telephone access,
  • willingness to be followed for 1 year.

排除标准

  • significant clinical comorbidities that prevented their return home after hospitalization,
  • younger than 21 years of age,
  • Short BLESSED cognitive screening tool scores ≥10.

结局指标

主要结局

SF-12 Short Form Health Survey (SF-12)

时间窗: change in general health (SF-12) score from baseline to 12 months

scores from 0 to 100 with higher scores representing better self-reported health

State-Trait Anxiety Inventory (STAI)

时间窗: change in anxiety (STAI) score from baseline to 12 months

Scores range from 20 to 80. Higher scores indicating greater anxiety.

Patient Concerns Assessment (PCA)

时间窗: Change in patient concerns from baseline to 12 months

scores from 0 to 58 in which lower scores reflect fewer symptoms

次要结局

  • Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)(change in efficacy expectations from baseline to 12 months)
  • Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias(change in number of ER visits from baseline to 12 months)
  • Number of ICD shocks(change in number of ICD shocks from baseline to 12 months)
  • Center for Epidemiologic Studies Depression Scale (CES-D)(change in depression (CES-D) score from baseline to 12 months)
  • Number of hospital admissions for ICD or cardiac related(change in number of hospital admission from baseline to 12 months)
  • Sudden Cardiac Arrest (SCA) Knowledge(change in SCA knowledge from baseline to 12 months)
  • Heart rhythm stability(change in heart rhythm stability from baseline to 12 months)
  • Number of clinic visits related to the ICD(change in number of clinic visits from baseline to 12 months)
  • Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale)(change in self-management behavior from baseline to 12 months)

研究者

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

Cynthia M. Dougherty

Professor

University of Washington

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