Patient and Intimate Partner Intervention to Improve Outcomes After an ICD
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
- 否
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
Cynthia M. Dougherty
Professor, Biobehavioral Nursing and Health Systems
University of Washington
