Improving Lung Transplant Outcomes with Coping Skills and Physical Activity

通过应对技巧和体力活动改善肺移植结果

基本信息

批准号：
10355486
负责人：
James A Blumenthal
金额：
$ 60.72万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-05-09 至 2024-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10355486
关键词：
Academic Medical Centers Accounting Activities of Daily Living Adherence Adopted Adverse event Aerobic Exercise Arthritis Chronic Chronic Disease Clinical Complex Control Groups Coping Skills Data Diabetes Mellitus Disease Management Disease-Free Survival Distress Education Educational Intervention Exercise Exhibits Frequencies Functional disorder Future Health behavior Heart failure Home Hospitalization Immunosuppressive Agents Incidence Individual Intervention Knowledge Lead Leisures Life Lung Lung Transplantation Lung diseases Measures Medical Mental Depression Mental Health Monitor Myocardial Ischemia Operative Surgical Procedures Outcome Outpatients Patients Pharmaceutical Preparations Physical activity Psychological Stress Psychometrics Quality of life Randomized Randomized Clinical Trials Research Respiratory Disease Risk Factors Sampling Studies Self Efficacy Self Management Solid Techniques Technology Testing Time Translating Transplant Recipients Transplantation United States Universities Walking Washington Well in self base biobehavior clinical practice clinical predictors common treatment coping cost effective depressive symptoms design effective therapy effectiveness evaluation emotional distress exercise adherence exercise intervention experience follow-up hospital readmission improved lung allograft mHealth medical schools medication compliance modifiable risk mortality mortality risk older patient organ transplant recipient patient population physical conditioning physical inactivity post-transplant prognostic index prospective psychologic psychological distress public health priorities pulmonary function randomized trial recruit reduce symptoms remote delivery remote monitoring respiratory secondary outcome skills skills training sleep quality standard of care therapy design translational impact treatment optimization trial comparing trial design

Academic Medical Centers Accounting Activities of Daily Living Adherence Adopted Adverse event Aerobic Exercise Arthritis Chronic Chronic Disease Clinical Complex Control Groups Coping Skills Data Diabetes Mellitus Disease Management Disease-Free Survival Distress Education Educational Intervention Exercise Exhibits Frequencies Functional disorder Future Health behavior Heart failure Home Hospitalization Immunosuppressive Agents Incidence Individual Intervention Knowledge Lead Leisures Life Lung Lung Transplantation Lung diseases Measures Medical Mental Depression Mental Health Monitor Myocardial Ischemia Operative Surgical Procedures Outcome Outpatients Patients Pharmaceutical Preparations Physical activity Psychological Stress Psychometrics Quality of life Randomized Randomized Clinical Trials Research Respiratory Disease Risk Factors Sampling Studies Self Efficacy Self Management Solid Techniques Technology Testing Time Translating Transplant Recipients Transplantation United States Universities Walking Washington Well in self base biobehavior clinical practice clinical predictors common treatment coping cost effective depressive symptoms design effective therapy effectiveness evaluation emotional distress exercise adherence exercise intervention experience follow-up hospital readmission improved lung allograft mHealth medical schools medication compliance modifiable risk mortality mortality risk older patient organ transplant recipient patient population physical conditioning physical inactivity post-transplant prognostic index prospective psychologic psychological distress public health priorities pulmonary function randomized trial recruit reduce symptoms remote delivery remote monitoring respiratory secondary outcome skills skills training sleep quality standard of care therapy design translational impact treatment optimization trial comparing trial design

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项目摘要

ABSTRACT For many patients with advanced lung disease, lung transplantation is the last viable treatment option to improve their quality of life (QoL) and extend their survival. With the growing number of individuals suffering from end-stage lung diseases, the frequency of lung transplantation has increased exponentially over the past two decades; more than 2,500 patients have been transplanted in the United States in 2016, a number that is expected to increase in the coming years. Despite advances in surgical techniques and medical management, median long term survival has plateaued at about 6 years, and, surprisingly, mental health QoL may not improve significantly after transplant. Developing treatments to extend life and improve QoL among individuals with advanced lung disease is a public health priority. Low functional capacity, physical inactivity, and heightened emotional distress are common following lung transplantation and are associated with increased risk of mortality and re-hospitalizations. Therefore we hypothesize that improving psychological well-being and functional capacity will further translate into improved QoL and better medical outcomes among lung transplant recipients. Prior research has shown that coping skills training (CST), designed both to teach patients self- management skills and to cope more effectively with psychological stress associated with chronic illness, is effective for a number of chronic conditions including diabetes, ischemic heart disease, arthritis, and heart failure. However, CST has not yet been evaluated as an intervention to facilitate self-management of lung transplant recipients, an even more complex condition in which patient self-management, regular exercise, and medication adherence are critical to successful outcomes. We propose a randomized clinical trial comparing a 12-week combined coping skills training and exercise (CSTEX) intervention with standard of care plus transplant education (SOC-ED) in a study sample of 150 lung transplant outpatients recruited from Duke University Medical Center and Washington University School of Medicine. The proposed CSTEX intervention, delivered by respiratory therapists using mHealth technology, is designed to reduce distress and depression and to improve key health behaviors, including physical activity, monitoring of pulmonary function, and adherence to medication, which have been shown to be related to medical outcomes in transplant recipients. Before and following treatment, overall distress and QoL indicated by both physical and mental health functioning, will be assessed. Effects of CSTEX on clinical outcomes also will be evaluated over a median follow-up period of 2.5 years. Findings from this trial could lead to the incorporation of coping skills training and exercise promotion into routine self-management interventions as cost-effective approaches to enhance disease management, QoL and medical outcomes in lung transplant patients and provide a basis for extending studies to other populations of patients with advanced lung disease.

抽象的对于许多患有晚期肺部疾病的患者，肺移植是最后一个可行的治疗选择提高生活质量（QOL）并扩大其生存。越来越多的人受苦从末期肺部疾病中，肺移植的频率在过去呈指数增长二十年； 2016年在美国已移植了2500多名患者，这一数字是预计未来几年会增加。尽管手术技术和医疗管理取得了进步，但长期生存的中位数已在大约6年的时间里稳定下来，令人惊讶的是，心理健康质量检查可能不会移植后显着改善。开发治疗以延长生活并改善个人的质量患有晚期肺部疾病是公共卫生的重点。低功能能力，身体不活动和肺移植后常见的情绪困扰是普遍的，并且与增加有关死亡率和重新建筑的风险。因此，我们假设改善心理健康和功能能力将进一步转化为肺移植中的QOL和更好的医疗结果收件人。先前的研究表明，应对技能培训（CST）旨在教患者自我管理技能并更有效地应对与慢性病相关的心理压力，是对于许多慢性病，包括糖尿病，缺血性心脏病，关节炎和心脏有效失败。但是，CST尚未被评估为促进肺部自我管理的干预措施移植接受者，一个更复杂的病情，患者自我管理，定期锻炼和药物依从性对于成功的结果至关重要。我们提出了一项随机临床试验，比较 12周的组合应对技能培训和锻炼（CSTEX）干预与护理标准Plus 从杜克大学招募的150个肺移植门诊患者的研究样本中的移植教育（SOC-ED）大学医学中心和华盛顿大学医学院。拟议的CSTEX干预，呼吸治疗师使用MHealth技术交付的旨在减少困扰和抑郁症并改善关键的健康行为，包括体育锻炼，监测肺功能以及遵守药物，这些药物已被证明与移植受者的医学结果有关。在治疗之前和之后，身体和心理健康都表明了总体困扰和质量功能将评估。 CSTEX对临床结果的影响也将通过中位数进行评估随访期为2。5年。该试验的发现可能会导致应对技能培训的纳入作为成本效益的方法，促进常规的自我管理干预措施肺移植患者的疾病管理，QOL和医疗结果，为扩展提供了基础对其他晚期肺部疾病患者的研究。