Phase III Trial of Pocket PATH: A Computerized Intervention to Promote Self-Care

描述（由申请人提供）：肺移植受者（LTR）比其他实体器官受者经历更多的移植相关并发症、更高的卫生资源利用率和死亡率。已知预防和检测早期并发症可降低未来肺功能受损的可能性，从而降低发病率和死亡率。尽管在整个肺移植过程中用于支持个人的供体器官和财政资源稀缺，但没有随机对照试验（RCT）测试旨在促进自我护理行为的干预措施，旨在改善移植相关健康并减少肺移植后的资源利用。这项拟议的第三阶段的目的是比较一种新的干预措施，口袋路径（个人助理跟踪健康）的有效性，以促进自我护理和改善健康结果相对于标准护理肺移植后。Pocket PATH为LTR提供了 手持设备与定制的数据记录，趋势和决策支持程序，以促进他们的自我护理行为。基于I期和II期试验的良好结果，现在提出了一项全面的III期RCT，以严格测试Pocket PATH在促进自我护理机构，自我护理行为，从而改善移植相关健康方面的有效性。 将214例在ICU恢复期存活的LTR样本随机分配至 干预组将被指导使用Pocket Path设备及其程序，这些程序旨在进行自我监测、遵守方案并将病情变化传达给移植团队，或者对照组将接受有关移植后方案（包括健康监测）的标准说明。将在基线、肺移植后出院后1周、2个月、6个月和12个月收集数据。将使用计划比较的纵向重复测量模型来检验主要目的的假设。据推测，与对照组受试者相比，Pocket PATH组受试者将发展更高水平的自我护理能力并更频繁地进行自我护理行为，因此将经历更少的移植相关并发症、再住院和更好的健康相关生活质量。公共卫生相关性：这项拟议的III期随机对照试验（RCT）的目的是测试一种新的干预措施，口袋路径（个人助理跟踪健康）促进自我护理机构，自我护理行为和移植相关的健康的有效性。尽管正在使用LTR设计和测试Pocket PATH，但只要稍加修改，这种干预措施就有可能通过促进自我护理行为产生更广泛的影响，从而改善其他实体器官接受者和患有其他慢性病的人的健康结果。拟议的研究非常符合以下倡议和优先事项：1）国家护理研究所强调生成和测试新技术以改善自我管理，2）NIH路线图倡议建立协作，跨学科团队以促进健康，3）最近的医学研究所报告让患者参与健康技术的设计。

DESCRIPTION (provided by applicant): Lung transplant recipients (LTRs) experience more transplant-related complications, higher health resource utilization and mortality than recipients of other solid organs. Prevention and detection of early complications is known to reduce the likelihood of future impairments in lung function and therefore morbidity and mortality. Despite the scarce donor organs and financial resources expended to support individuals throughout the lung transplant experience, no randomized controlled trials (RCTs) have tested interventions designed to promote self-care behaviors with the aim of improving transplant-related health and reducing resource utilization after lung transplant. The purpose of this proposed phase III is to compare the efficacy of a novel intervention, Pocket PATH (Personal Assistant for Tracking Health) for promoting self-care and improving health outcomes relative to standard care after lung transplantation. Pocket PATH provides LTRs a handheld device with customized data recording, trending and decision-support programs to promote their selfcare behaviors. Based on the promising results from the phase I and II trials, a full-scale phase III RCT is now proposed to rigorously test the efficacy of Pocket PATH in promoting self-care agency, self-care behaviors and hence improving transplant-related health. A sample of 214 LTRs who survive the immediate ICU recovery period will be randomly assigned to either the intervention group, who will be instructed to use the Pocket Path device and its programs designed for self-monitoring, adhering to the regimen, and communicating condition changes to the transplant team, or the control group who will receive standard instructions regarding the post-transplant regimen (including health monitoring). Data will be collected at baseline, 1 week, 2, 6 and 12 months after discharge from the hospital following lung transplantation. Longitudinal, repeated-measures models with planned comparisons will be used to test the hypotheses for the primary aims. It is hypothesized that subjects in the Pocket PATH group will develop higher levels of self-care agency and perform self-care behaviors more often than subjects in the control group and therefore will experience fewer transplant-related complications, re-hospitalizations and better health related quality of life. PUBLIC HEALTH RELEVANCE: The purpose of this proposed phase III randomized controlled trial (RCT) is to test the efficacy of a novel intervention, Pocket PATH (Personal Assistant for Tracking Health) for promoting self-care agency, self-care behaviors and transplant-related health. Although Pocket PATH is being designed and tested with LTRs, with little modification this intervention has the potential to have a broader impact by promoting self-care behaviors, and thus improving health outcomes, in recipients of other solid organs and in persons with other chronic illnesses. The proposed study fits well with the following initiatives and priorities: 1) National Institute of Nursing Research's emphasis on generating and testing new technologies to improve self-management, 2) the NIH Roadmap initiative to build collaborative, interdisciplinary teams to promote health, and 3) the recent Institute of Medicine report to involve patients in the design of health technologies.