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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

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.

抽象的对于许多晚期肺病患者来说，肺移植是最后可行的治疗选择提高他们的生活质量 (QoL) 并延长他们的生存期。随着受苦受难的人数不断增加从终末期肺部疾病开始，肺移植的频率在过去呈指数级增长二十年； 2016年，美国有超过2,500名患者接受了移植手术，这个数字相当于预计未来几年将会增加。尽管外科技术和医疗管理取得了进步，中位长期生存期稳定在 6 年左右，令人惊讶的是，心理健康生活质量可能不会移植后明显改善。开发治疗方法以延长个体寿命并提高生活质量患有晚期肺部疾病是公共卫生的首要任务。功能能力低下、缺乏身体活动，肺移植后情绪困扰加剧很常见，并且与增加死亡和再住院的风险。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患者生活质量的改善和更好的医疗结果收件人。先前的研究表明，应对技能训练（CST）旨在教会患者自我应对管理技能并更有效地应对与慢性病相关的心理压力对多种慢性疾病有效，包括糖尿病、缺血性心脏病、关节炎和心脏病失败。然而，CST 尚未被评估为促进肺部自我管理的干预措施。对于移植受者来说，这是一种更加复杂的情况，患者需要进行自我管理、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，比较为期 12 周的综合应对技能训练和锻炼 (CSTEX) 干预以及标准护理加杜克大学招募的 150 名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 干预措施，由呼吸治疗师使用移动医疗技术提供，旨在减少痛苦和抑郁改善关键的健康行为，包括体力活动、肺功能监测，以及坚持用药，已被证明与移植受者的医疗结果有关。治疗前后，身体和心理健康状况表明的总体痛苦和生活质量功能，将被评估。 CSTEX 对临床结果的影响也将通过中位数进行评估随访期2.5年。这项试验的结果可能会导致纳入应对技能培训并将推广活动纳入日常自我管理干预措施中，作为增强肺移植患者的疾病管理、生活质量和医疗结果，并为扩展提供基础对其他晚期肺病患者人群的研究。