Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Feasibility of at-home assessments
研究概览
简要总结
The purpose of this study is to study use of advance Digital Health Technologies (DHT) and its validity as measures for assessing progression in Amyotrophic Lateral Sclerosis (ALS) patients. A total of 80 ALS patients will be recruited across US, and will involve two sites - St. Joseph Hospital and Medical Center in Phoenix, AZ, and Emory University ALS Clinic in Atlanta. This will be a fully remote observational study and will employ remote data collection platforms such as (a) A digital spirometry device powered by a mobile app will be used to measure vital capacity; (b) A clinical-grade voice recording app will be used to evaluate speech function; (c) A medical-grade wearable sensor will be used to monitor activity levels and sleep patterns; and (d) Standardized Electronic Clinical Outcome Assessments (eCOA) and Patient Reported Outcomes (ePRO) will be used to evaluate quality of life and cognitive abilities.
The main goals of this study is to answer some of these questions:
- Can ALS patients measure important aspects of disease progression at home, either by themselves with appropriate training or with assistance of a coordinators via virtual visit?
- Which clinical outcome measures collected through DHT are sensitive indicators of ALS progression?
- Are the measures reproducible and whether they can correlate with gold standard assessments?
The results of this study have the potential to provide valuable information for designing future ALS trials that are more decentralized, more patient-centric, and require less visits to the clinic which typically become a major burden with disease progression
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 to
- •Diagnosed with definite, probable, or possible ALS according to the modified El Escorial Criteria (EEC) or diagnosed with ALS using the Gold Coast Criteria.
- •Must be able to ambulate independently at the time of enrollment, with or without the use of foot braces or cane.
- •A vital capacity score of ≥40% of the predicted value (at last known in-person visit and if available).
- •Intelligible speech with occasional repetition.
- •Willingness and medical ability to comply with scheduled visits and study procedures.
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI).
- •Possession of a smartphone, and willingness to install study apps on it.
- •Continuous internet access at home, with stable broadband internet access.
- •Sufficiently proficient in English to understand and complete questionnaires and follow instructions using smartphone apps.
排除标准
- •Diagnosed with a superimposed medical condition that could confound study procedures in the opinion of the investigator.
- •Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant's ability to comply with the protocol.
- •Any other reasons that, in the opinion of the PI, the candidate is determined to be unsuitable for entry into the study.
结局指标
主要结局
Feasibility of at-home assessments
时间窗: 12 months
The average number of at-home assessments completed by each subject will be calculated each quarter using Wald method
次要结局
未报告次要终点