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

描述（由申请人提供）：肺移植受者比其他实体器官受者经历更多的移植相关并发症，更高的健康资源利用率和死亡率。预防和发现早期并发症可以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体的供体器官和财政资源稀缺，但没有随机对照试验（rct）测试旨在促进自我保健行为的干预措施，目的是改善肺移植后的移植相关健康和减少资源利用。本III期研究的目的是比较一种新型干预措施——Pocket PATH （Personal Assistant for Tracking Health）在促进肺移植术后自我护理和改善健康结果方面与标准护理的效果。Pocket PATH提供ltr

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.