Remote Pulmonary Function Testing and Nurse Respiratory Health Coaching in Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Date of Identification of Noninvasive Ventilation (NIV) Need From rPFT Monitoring
研究概览
简要总结
Comparison of respiratory outcomes in patients receiving telemedicine-guided remote pulmonary function testing (rPFT) with or without the additional support of nurse coaching. This is a randomized controlled study which assesses the effects rPFT and coaching on respiratory outcomes and quality of life.
详细描述
This is a two-arm, randomized study to determine 1) whether weekly monitoring of respiratory function can lead to timelier initiation of NIV and 2) whether structured nurse coaching leads to improved self-efficacy for managing disease and better maintenance of respiratory health. For enrollees in both arms, standard FVC and MIP measurements obtained approximately every three months by the respiratory therapist during ALS Clinic are supplemented with self-administered rPFTs performed weekly. Enrollees in the rPFT+NRHC (nurse respiratory health coaching) arm will additionally receive monthly coaching with the study nurse via telehealth. Outcomes include measures of quality of life and self-efficacy for managing disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Possess a diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria [Brooks2000].
- •Be 18 years of age or older.
- •Have a caregiver available to participate in the study
- •Symptom onset within the last three years.
- •Have a computer and home internet service sufficient for engaging in telemedicine sessions.
- •Have a second device capable of downloading the spirometer application from an app store (Android- or iOS-based smartphone or tablet).
- •Caregivers:
- •Be 18 years of age or older, of either gender.
- •Be able and willing to provide informed consent.
排除标准
- •Use of NIV or diaphragm pacer at time of obtaining informed consent.
- •FVC ≤50% predicted or MIP > -60 cm of water.
- •ALS Functional Rating Scale (ALSFRS-R) [Cedarbaum1999] score on day of screening of ≥2 on items for speech, swallowing, and salivation. These items are indicators of bulbar dysfunction, which limits the reliability of PFT administration.
- •Cognitive impairment, as judged by the ALS clinic neurologist, that prevents participation in the study.
- •Caregivers: None
结局指标
主要结局
Date of Identification of Noninvasive Ventilation (NIV) Need From rPFT Monitoring
时间窗: 1 year
NIV is typically prescribed when an individual demonstrates signs of respiratory failure. In this study, forced vital capacity (FVC) of 50% or less of the predicted value serves as a surrogate for respiratory failure and constitutes identification of NIV need. First date of remote measurement of FVC 50% or less of the predicted value is reported here.
Date of Identification of NIV Need From Standard PFT Monitoring
时间窗: From date of enrollment until first identification of non-invasive ventilation need, assessed up to 1.5 years
NIV is typically prescribed when an individual demonstrates signs of respiratory failure. In this study, forced vital capacity (FVC) of 50% or less of the predicted value serves as a surrogate for respiratory failure and constitutes identification of NIV need. First date of standard, in-clinic measurement of FVC 50% or less of the predicted value is reported here.
Self-efficacy for Managing Medications and Treatments
时间窗: 1 year
The self-efficacy assessment contains questions from the Patient-Reported Outcomes Measurement Information System (PROMIS) item banks on Self-Efficacy for Managing Medications and Treatments (4 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.
Self-efficacy for Managing Social Interactions
时间窗: 1 year
The self-efficacy assessment contains questions from the PROMIS item bank on Self-Efficacy for Managing Social Interactions (5 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.
Self-efficacy for Managing Symptoms
时间窗: 1 year
The self-efficacy assessment contains questions from the PROMIS item bank on Self-Efficacy for Managing Symptoms (9 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.
次要结局
- Sleep Related Impairment(1 year)
- rPFT Adherence(1 year)
- Dyspnea Characteristics(1 year)
- Respiratory-related Symptoms(1 year)
- Dyspnea Functional Limitations(1 year)
研究者
Zachary Simmons, MD
Professor of Neurology and Humanities
Milton S. Hershey Medical Center