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临床试验/NCT01252615
NCT01252615已完成2 期

Patient and Intimate Partner Intervention to Improve Outcomes After an ICD

University of Washington2 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
301
试验地点
2
主要终点
Physical functioning

研究概览

简要总结

The goal of this study is to compare a patient only to a patient+partner intervention on recovery outcomes of patients and partners after Implantable Cardioverter Defibrillator (ICD) implantation.

详细描述

The goal of this randomized trial is to test a patient+partner intervention against the patient only intervention on recovery outcomes of patients and partners after ICD implantation. By interventing with both ICD patients and their partners, we expect to further improve outcomes of patients and aid in recovery of partners. Over a five year period we will test the effects of a 12 week patient+partner intervention against a patient only intervention in the first year subsequent to ICD implantation, using a 2 group (N=150/group) randomized clinical trial design. Relevant data will be collected on ICD patients and intimate partners at hospital discharge, 1, 3, 6, 12 months post-ICD implantation. The four major outcomes are: physical functioning, psychological adjustment, health care utilization, and relationship impact. The primary analysis of treatment effect is the change in outcome variables from baseline to 3 months for the patient and partner. Secondarily, exploring long term effects of the intervention, theoretical elements, and the intervention effects by ICD implant reason will be determined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • first ICD implantation due to either primary or secondary prevention of SCA
  • intimate partner (spouse, lover, or life partner) living at the same residence and willing to participate
  • able to read, speak, and write English
  • access to telephone for 1 year after ICD implantation

排除标准

  • clinical co-morbidities that severely impair cognitive and physical functioning at telephone screening
  • Short BLESSED score > 6
  • age less than 21 years
  • AUDIT-C score > 4 for alcohol use
  • ASSIST 2.0 score > 4 for daily non-medical use of opiates or hallucinogens,

结局指标

主要结局

Physical functioning

时间窗: 3 months

symptoms, health related quality of life, steps/day

次要结局

  • psychological adjustment(3 months)

研究者

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

Cynthia M. Dougherty

Professor, Biobehavioral Nursing and Health Systems

University of Washington

研究点 (2)

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