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

Pocket PATH 第三阶段试验：促进自我保健的计算机干预

• 批准号: 8059669
• 负责人: ANNETTE J DE VITO DABBS
• 金额: $ 58.99万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8059669
• 关键词: Address; Attention; Behavior; Chronic Disease; Clinical; Control Groups; Data; Data Analyses; Detection; Devices; Early Diagnosis; Future; Health; Health Resources; Health Technology; Hospitalization; Hospitals; Impairment; Individual; Institute of Medicine (U.S.); Instruction; Intervention; Lung; Lung Transplantation; Measures; Medical; Modeling; Modification; Monitor; Morbidity - disease rate; National Institute of Nursing Research; Organ; Organ Donor; Organ Transplantation; Outcome; Patients; Performance; Persons; Phase; Phase I/II Trial; Phase III Clinical Trials; Prevention; Process; Psychosocial Factor; Randomized; Randomized Controlled Trials; Recovery; Regimen; Relative (related person); Reporting; Resources; Respiratory physiology; Sampling; Schedule; Self Care; Self Management; Solid; Technology; Testing; Transplant Recipients; Transplantation; United States National Institutes of Health; Visit; base; comparative efficacy; computerized; design; efficacy testing; end stage disease; experience; group intervention; health related quality of life; improved; meetings; mortality; new technology; novel; programs; prototype; satisfaction; standard care; therapy design; trend; usability

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.

描述(由申请人提供)：与其他实体器官的接受者相比，肺移植接受者经历了更多与移植相关的并发症，更高的卫生资源利用率和死亡率。众所周知，预防和检测早期并发症可以减少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)测试旨在促进自我护理行为的干预措施，目的是改善与移植相关的健康，减少肺移植后的资源利用。这个拟议的第三阶段的目的是比较一种新型干预措施Pocket Path(个人健康跟踪助理)在促进肺移植后自我护理和改善健康结果方面与标准护理相比的效果。Pocket Path为LTRS提供了 手持设备，具有定制的数据记录、趋势和决策支持程序，以促进他们的自我护理行为。基于第一阶段和第二阶段试验的可喜结果，现在建议进行一项全面的第三阶段随机对照试验，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与移植相关的健康方面的有效性。 在即时ICU恢复期幸存下来的214名LTR样本将被随机分配到 要么是干预组，他们将被指示使用Pocket Path设备及其为自我监控而设计的程序，遵守方案，并将病情变化传达给移植团队；或者是对照组，他们将收到关于移植后方案(包括健康监测)的标准说明。数据将在肺移植后出院后基线、1周、2周、6个月和12个月收集。带有计划比较的纵向重复测量模型将被用来检验主要目标的假设。据假设，Pocket Path组的受试者将比对照组的受试者发展出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、再次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Pocket Path(个人健康跟踪助理)在促进自我护理机构、自我护理行为和移植相关健康方面的有效性。尽管Pocket Path正在使用LTRS进行设计和测试，但这种干预措施几乎没有修改，有可能通过促进自我护理行为产生更广泛的影响，从而改善其他固体器官的接受者和患有其他慢性病的人的健康结果。这项拟议的研究符合以下倡议和优先事项：1)国家护理研究所强调产生和测试新技术以改善自我管理，2)NIH路线图倡议建立协作的跨学科团队以促进健康，以及3)最近的医学研究所报告，让患者参与健康技术的设计。