Rehabilitation of Airway Protection in Parkinson's Disease: Comparing In-Person and Telehealth Service Delivery Models

帕金森病气道保护的康复：比较面对面和远程医疗服务提供模式

• 批准号: 10419307
• 负责人: MICHELLE S TROCHE
• 金额: $ 62.51万
• 依托单位: COLUMBIA UNIVERSITY TEACHERS COLLEGE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10419307
• 关键词: Address; Affect; Aftercare; Aspiration Pneumonia; Caregiver Burden; Caring; Cause of Death; Cessation of life; Client satisfaction; Clinical; Clinical Research; Coughing; Data; Deglutition Disorders; Disease; Elderly; Fibrinogen; Functional disorder; Future; Geographic Locations; Geography; Goals; Health; Health Care Costs; Health Insurance; Healthcare; Hospitalization; Impaired cognition; Improve Access; Individual; Insurance Coverage; Life; Light; Maintenance; Mission; Modality; Nature; Outcome; Parkinson Disease; Patient-Focused Outcomes; Patients; Peak Expiratory Flow Rate; Persons; Phase; Physiological; Population; Public Health; Quality of life; Randomized Clinical Trials; Rehabilitation therapy; Research; Role; Service delivery model; Services; Severity of illness; Site; United States; United States National Institutes of Health; Work; arm; barrier to care; base; care burden; clinical center; clinically translatable; cognitive function; comparative effectiveness; efficacious intervention; health care disparity; improved; muscle strength; novel; pressure; programs; rehabilitation paradigm; rehabilitation service; rehabilitation strategy; response; skills training; standard of care; strength training; telehealth; treatment adherence; treatment duration; treatment services; trial comparing; urban area

PROJECT SUMMARY/ABSTRACT Progressive disorders of airway protection, such as swallowing disorders (dysphagia) and cough disorders (dystussia), are highly prevalent in PD and have significant negative implications for health and quality of life. In fact, aspiration pneumonia, commonly associated with dysphagia/dystussia, is a leading cause of death in PD. Despite this, there is currently no established standard of care for the treatment of airway protective disorders in this population. Even more critically, approximately 40% of individuals with PD in the United States do not access rehabilitation services or receive specialized care for these potentially life-threatening airway protective deficits. Expiratory Muscle Strength Training (EMST) and Cough Skill Training (CST) have been found to improve airway protective disorders in PD and be feasible via telehealth. However, a significant clinical-research gap remains in that it has not been demonstrated that clinical outcomes are comparable (non-inferior) when these treatments are delivered via telehealth versus in-person. This gap limits access to these important services with detrimental effects to health and quality of life. The long-term goal of this line of research is to improve the health outcomes of individuals with PD, specifically as they relate to airway protective dysfunction. The objective of this application is to pair EMST + CST – and compare clinical and patient-centered outcomes when conducted in-person versus via telehealth in the short- and the long-term. Also, we will assess the role of specific patient burden factors and resultant treatment adherence on clinical outcomes. Therefore, the aims of this study are to: 1) Compare clinical and patient-centered outcomes following four weeks of intensive in-person vs. telehealth EMST+CST treatment in persons with PD, 2) Compare clinical and patient-centered outcomes from a long-term EMST+CST maintenance program offered in-person vs. via telehealth in persons with PD, and 3) Identify the role of specific patient burden factors (i.e., geographic location, cognitive function, disease severity, and caregiver burden) on treatment adherence in the short- and long-term and the influence of treatment adherence on clinical outcomes. We will achieve these aims by conducting a two-arm, two site, randomized clinical trial in 120 people with PD comparing in-person vs. telehealth EMST+CST treatment after a four-week intensive period (aim1) and after a one year maintenance treatment period (with assessments at six and 12 months – aim 2). We anticipate our findings will result in immediately translatable clinical deliverables that will have broad impact for reduced burden and improved accessibility of treatment. Further, these findings will inform our future studies investigating these treatments and service delivery models on long-term outcomes (i.e., aspiration pneumonia, hospitalization, death), accessibility, and healthcare costs.

项目总结/摘要 进行性气道保护障碍，如吞咽障碍（吞咽困难）和咳嗽障碍 （味觉障碍），在PD中非常普遍，对健康和生活质量具有显著的负面影响。在 事实上，吸入性肺炎，通常与吞咽困难/吞咽困难相关，是PD死亡的主要原因。 尽管如此，目前还没有确定的标准治疗气道保护性疾病， 这个人口。更重要的是，在美国，大约40%的PD患者无法获得 康复服务或接受专门护理，这些潜在的危及生命的气道保护缺陷。 呼气肌力训练（埃姆斯特）和咳嗽技巧训练（CST）已被发现可以改善气道 保护性疾病，并通过远程医疗可行。然而，一个显着的临床研究差距仍然存在， 尚未证明这些治疗的临床结局具有可比性（非劣效性）， 是通过远程医疗还是面对面提供。这一差距限制了获得这些重要服务的机会， 影响健康和生活质量。这项研究的长期目标是改善健康状况， PD患者，特别是因为它们与气道保护功能障碍有关。本申请的目的 将埃姆斯特+ CST配对，并比较当面进行与 通过远程医疗在短期和长期。此外，我们将评估特定患者负担因素的作用， 从而导致治疗依从性对临床结局的影响。因此，本研究的目的是：1）比较临床 4周密集面对面与远程医疗埃姆斯特+CST治疗后的以患者为中心的结局 2）比较长期埃姆斯特+CST的临床和以患者为中心的结局 在PD患者中，面对面与通过远程医疗提供的维护程序，以及3）确定特定 患者负担因素（即，地理位置、认知功能、疾病严重程度和照顾者负担） 短期和长期的治疗依从性以及治疗依从性对临床结局的影响。 我们将通过在120名PD患者中进行一项两组、两个地点的随机临床试验来实现这些目标 比较4周强化期（aim 1）和4周后的面对面与远程保健埃姆斯特+CST治疗， 1年维持治疗期（在6个月和12个月时进行评估-目标2）。我们期待我们的 研究结果将产生可立即翻译的临床可交付成果，对减轻负担产生广泛影响 并改善治疗的可及性。此外，这些发现将为我们未来的研究提供信息， 治疗和服务提供模式对长期结果的影响（即，吸入性肺炎，住院治疗， 死亡）、可及性和医疗费用。