Rehabilitation of Airway Protection in Parkinson's Disease

Parkinson Disease Clinical Trial

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

Status Recruiting

Clinical Trial Summary

Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. The investigators will examine the comparative effectiveness of a novel treatment paradigm delivered in-person versus via telehealth in persons with PD, as well as the role of patient burden and treatment adherence on outcomes; thus, the proposed research is relevant to public health and in line with NIH's mission to identify novel, efficacious, and accessible rehabilitation strategies for short- and long-term improvement of dysfunctional airway protection in PD.

Clinical Trial Description

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, the investigators 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. The investigators 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). The investigators 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. ;

Related Conditions & MeSH terms

• Dysphagia
• Parkinson Disease

• NCT number: NCT05700825
• Study type: Interventional
• Source: Teachers College, Columbia University
• Contact: Michelle Troche, PhD
• Phone: 212-678-3072
• Email: uadlab@tc.columbia.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: August 11, 2022
• Completion date: September 1, 2027