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

• 批准号: 8294644
• 负责人: CYNTHIA M DOUGHERTY
• 金额: $ 75.13万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 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/8294644
• 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

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的第三次也是最后一次重新提取“患者和亲密的伴侣干预，以改善ICD后的健康状况”。在我们先前的工作中，“突然心脏骤停后的护理干预措施” [NINR，R01 NRO 4766]，我们证明了症状，焦虑，知识和自我效能的改善，同时减少了ICD相关的与心脏骤停（SCA）幸存者（SCA）幸存者（SCA）幸存者的数量，这些人获得了植入式Cardioverter Defibrilltator（ICD），这是第一次获得植入式羊皮纸（ICD）。此外，我们发现了ICD后SCA幸存者的整体调整中亲密伙伴的重要性。我们没有在先前的研究中资助与亲密伴侣进行干预。因此，这项随机试验的目的是针对患者的干预措施（SI-NTS-PTG）对ICD植入后患者和伴侣的康复结果进行研究。通过干预ICD患者及其伴侣，我们希望进一步改善患者的预后并有助于恢复伴侣。 SCA声称每年美国约有40万寿命，占心血管疾病总死亡人数的65％。在过去的几年中，ICD的迹象已扩大，导致了大约100,000个新的ICD植入物，以预防SCA/年。有一个有效的替代方法可以流产猝死，有必要解决患者及其家人如何适应该技术。在五年的时间内，我们将使用2组（n = 150/组）随机临床试验设计，在ICD植入后的第一年中对仅患者干预（SI-NTS-PTG）干预对仅患者干预（SI-NTS）的影响。相关数据将在ICD患者和亲密伴侣出院时收集1、3、6、12个月植入后。四个主要结果是：身体功能，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个月的变化变化。其次，将确定干预措施的长期影响，理论要素以及ICD植入物理性的干预效果。所有干预措施旨在通过电话或通过美国邮件进行交付，以吸引无法开车和居住在农村地区的ICD患者和合作伙伴。这项研究通过有助于心理和行为干预措施的知识来提高NHLBI的科学议程，以改善心脏骤停后的预后。 公共卫生相关性：这项随机试验的目的是对患者和伴侣干预对患者的干预仅干预ICD植入后患者和伴侣的康复结果。通过干预ICD患者及其伴侣，我们希望进一步改善患者的预后并有助于恢复伴侣。 SCA声称每年美国约有40万寿命，占心血管疾病总死亡人数的65％。在过去的几年中，ICD的迹象已扩大，导致大约35,000个新的ICD植入物，用于SCA/年的初级和二级预防。有一个有效的替代方法可以流产猝死，有必要解决患者及其家人如何适应该技术。