Patient and Intimate Partner Intervention to Improve Health Outcomes After an ICD

患者和亲密伴侣干预以改善 ICD 后的健康结果

基本信息

批准号：
7892544
负责人：
CYNTHIA M DOUGHERTY
金额：
$ 76.36万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-07-15 至 2014-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7892544
关键词：
Address Affect Anxiety Behavior Behavior Therapy Cardiac Cardiovascular Diseases Caregiver Burden Cessation of life Clinical Trials Clinical Trials Design Data Depressed mood Distress Elements Enrollment Family Funding Goals Health Heart Arrest Heart failure Hospitalization Hospitals Implant Implantable Defibrillators Intervention Investigation Knowledge Life Long-Term Effects Mails Measures Medial Mediating Mental Depression Modeling Morbidity - disease rate National Heart, Lung, and Blood Institute Outcome Outpatients Patients Physical Function Post-Traumatic Stress Disorders Primary Prevention Protocols documentation Psychological adjustment Randomized Randomized Clinical Trials Recovery Recurrence Reporting Risk Scientific Advances and Accomplishments Secondary Prevention Self Efficacy Shock Social support Sudden Death Survivors Symptoms Technology Telephone Testing Time Transportation Ventricular Arrhythmia Visit Work caregiving design expectation experience health care service utilization heuristics implantation improved intervention effect intervention program mortality nursing intervention prevent psychologic psychological outcomes public health relevance randomized trial rural area satisfaction social cognitive theory sudden cardiac death therapy design treatment effect

项目摘要

DESCRIPTION (provided by applicant): This is the third and final re-submission of 1 R01 HL086580-02 "Patient and Intimate Partner Intervention to Improve Health Outcomes after an ICD". In our previous work, "Nursing Interventions Following Sudden Cardiac Arrest" [NINR, R01 NRO 4766], we demonstrated improvements in symptoms, anxiety, knowledge, and self-efficacy while reducing the number of ICD related outpatient visits in sudden cardiac arrest (SCA) survivors who received an implantable cardioverter defibrillator (ICD) for the first time. In addition, we discovered the pivotal importance of the intimate partner in the overall adjustment of the SCA survivor after an ICD. We were not funded in our previous study to intervene with intimate partners. Therefore, the goal of this randomized trial is to test a patient+partner intervention (SI-NTS-PTG) against the patient only intervention (SI- NTS) on recovery outcomes of patients and partners after ICD implantation. By intervening with both ICD patients and their partners, we expect to further improve outcomes of patients and aid in recovery of partners. SCA claims approximately 400,000 lives in the US per year, representing 65% of the total deaths resulting from cardiovascular disease. The indications for an ICD have expanded in the last few years, resulting in approximately 100,000 new ICD implants for both primary and secondary prevention of SCA/year. With an effective alternative in place to abort sudden cardiac death, it is necessary to address how patients and their families adapt to the technology. Over a five year period we will test the effects of a 12 week patient+partner (SI-NTS-PTG) intervention against a patient only intervention (SI-NTS) 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. All interventions are designed to be delivered over the telephone or through U.S. mail in order to reach ICD patients and partners who are not able to drive and live in rural areas. This study advances the scientific agenda of the NHLBI by contributing to the knowledge of psychological and behavioral interventions to improve outcomes after sudden cardiac arrest. PUBLIC HEALTH RELEVANCE: The goal of this randomized trial is to test a patient and partner intervention against the patient only intervention on recovery outcomes of patients and partners after ICD implantation. By intervening with both ICD patients and their partners, we expect to further improve outcomes of patients and aid in recovery of partners. SCA claims approximately 400,000 lives in the US per year, representing 65% of the total deaths resulting from cardiovascular disease. The indications for an ICD have expanded in the last few years, resulting in approximately 35,000 new ICD implants for both primary and secondary prevention of SCA/year. With an effective alternative in place to abort sudden cardiac death, it is necessary to address how patients and their families adapt to the technology.

描述（由申请人提供）：这是 1 R01 HL086580-02“患者和亲密伴侣干预以改善 ICD 后健康结果”的第三次也是最后一次重新提交。在我们之前的工作“心脏骤停后的护理干预”[NINR，R01 NRO 4766] 中，我们证明了症状、焦虑、知识和自我效能的改善，同时减少了心脏骤停 (SCA) 中与 ICD 相关的门诊就诊次数）首次接受植入式心脏复律除颤器 (ICD) 的幸存者。此外，我们发现亲密伴侣在 ICD 后 SCA 幸存者的整体调整中至关重要。我们之前的研究没有资助对亲密伴侣进行干预。因此，这项随机试验的目标是测试患者+伴侣干预 (SI-NTS-PTG) 与仅患者干预 (SI-NTS) 对 ICD 植入后患者和伴侣恢复结果的影响。通过对 ICD 患者及其伴侣进行干预，我们期望进一步改善患者的预后并帮助伴侣康复。在美国，SCA 每年夺去约 40 万人的生命，占心血管疾病死亡总数的 65%。 ICD 的适应症在过去几年中不断扩大，每年约有 100,000 个新的 ICD 植入物用于 SCA 的一级和二级预防。有了有效的替代方法来终止心源性猝死，就有必要解决患者及其家人如何适应该技术的问题。在五年的时间里，我们将使用 2 组（N =150/组）随机临床试验设计。将收集 ICD 患者和亲密伴侣出院时以及 ICD 植入后 1、3、6、12 个月的相关数据。四个主要结果是：身体机能、心理调整、医疗保健利用和关系影响。治疗效果的主要分析是患者和伴侣的结果变量从基线到 3 个月的变化。其次，探索干预的长期效果、理论要素以及ICD植入原因的干预效果。所有干预措施均旨在通过电话或美国邮件提供，以便接触到无法驾驶和生活在农村地区的 ICD 患者和伴侣。这项研究通过增进心理和行为干预知识以改善心脏骤停后的预后来推进 NHLBI 的科学议程。公共卫生相关性：这项随机试验的目的是测试患者和伴侣干预与仅患者干预对 ICD 植入后患者和伴侣恢复结果的影响。通过对 ICD 患者及其伴侣进行干预，我们期望进一步改善患者的预后并帮助伴侣康复。在美国，SCA 每年夺去约 40 万人的生命，占心血管疾病死亡总数的 65%。 ICD 的适应症在过去几年中不断扩大，每年约有 35,000 个新的 ICD 植入物用于 SCA 的一级和二级预防。有了有效的替代方法来终止心源性猝死，就有必要解决患者及其家人如何适应该技术的问题。