The E-health Application To Modify ORal Energy Intake and Measure Outcomes REmotely in ALS Clinical Trial (EAT MORE2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Patient Reported Outcome Measurement Information System Short Form v1.0
研究概览
简要总结
This is phase IIa feasibility and tolerability study of a mobile health (mHealth) application designed to study the effects of remote dietary counseling on disease progression and quality of life. The study will consist of two phases: Part I will consist of building and beta-testing the ALS Nutrition app and Part II will consist of enrolling a larger cohort of users into the app.
详细描述
The investigators' prior work has shown that nutrition is an important modifiable prognostic factor for ALS disease progression and survival. In the recently completed E-Health Application To Measure Outcomes Remotely (EAT MORE) clinical trial (sponsored by the ALS Association), the investigators found that nutritional counseling supported by a mobile health (mHealth) app was associated with 0.5 points/month slower ALSFRS-R progression (p=0.17) and improved quality of life (p=0.09).
The investigators are now designing an ALS-specific app that can be used by everyone with ALS, including those who do not live near ALS Centers. The app would help to address gaps in the delivery of ALS care by providing nutritional counseling, helping patients to manage and track their disease symptoms, and communicating with their providers. After the initial design has been tested by a group of NEALS patients and their caregivers, the study will advertise the app widely to recruit a larger group of ALS patients to measure nutrition and outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Participants with a diagnosis of ALS (self-reported)
- •Male or female subjects aged 18 years or older.
- •Participants must be capable of providing informed consent and complying with trial procedures.
- •Participants must have access to an iOS or Android device to allow the to download the apps.
- •Exclusion criteria:
- •Use of a feeding tube (G-tube or J-tube)
- •BMI>30 kg/m2 regardless of weight loss history
- •A history of cardiovascular disease (stroke, myocardial infarction, peripheral vascular disease)
- •A history of diabetes (self-reported)
排除标准
- 未提供
结局指标
主要结局
Patient Reported Outcome Measurement Information System Short Form v1.0
时间窗: Change over time over 6 months
Patient Reported Global Health Questionnaire where the higher the T score the better
次要结局
- ALS Functional Rating Scale-Revised(Change over time over 6 months)
研究者
Anne-Marie Alexandra Wills, MD
Assistant Professor of Neurology
Massachusetts General Hospital