Electronic-health Application To Measure Outcomes REmotely Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Estimated Mean Change in Weight From Baseline to 6 Months
研究概览
简要总结
This is a phase II feasibility, safety, tolerability and preliminary efficacy study of an e-Health application versus in-person nutritional counseling to maintain or increase weight in patients with neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), Parkinson's Disease (PD) and Huntington's disease (HD). Primary Objectives include the feasibility, safety, tolerability and efficacy of an e-Health application to maintain or increase body weight compared to in-person nutritional counseling. Secondary Objectives are to measure the number of calories required to maintain or increase body weight in neurodegenerative diseases at all stages of the disease. Tertiary Objectives are to test the effects of an e-Health application compared to in-person nutritional counseling on disease progression using the ALSFRS-R, UHDRS or UDysRS, on survival, and on quality of life using the PROMIS SF v1.1 scale.
详细描述
This is a single center, randomized, open-label, placebo controlled, parallel group study. The study treatment period is approximately 6 months and observation period is approximately 7 months. There are three parallel treatment groups: in-person nutritional counseling, nutritional counseling using an e-Health App, and standard care. Subjects will be randomly assigned in a 1:1:1 ratio using a computer-generated randomization scheme. Subjects in the two intervention arms will be given caloric recommendations designed to cause weight stability or modest weight gain, depending on their current BMI and weight loss history. All participants in the intervention arms will receive counseling either in-person or remotely through the App by registered dietitians (RD) working in the Bionutrition department of the Clinical Research Center at MGH. At MGH, approximately 150 ALS subjects (50 per treatment group) will be enrolled. Approximately 75-150 PD and HD subjects will enroll.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adults with neurodegenerative diseases such as ALS, PD or HD with or without a history of unintentional weight loss.
- •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 an MGH swallowing screening tool score>5 at the time of the screening visit
- •Participants or a designated caregiver must be able to obtain home weights and communicate to their RD
排除标准
- •Clinical evidence of unstable medical or psychiatric illness, in the investigator's judgment, which would prevent the participant from completing their assessments.
- •BMI > 35 combined with a history of cardiovascular disease; or a history of diabetes regardless of BMI.
结局指标
主要结局
Estimated Mean Change in Weight From Baseline to 6 Months
时间窗: Change over time from Baseline to 6 months
The Primary Aim is to study the feasibility and efficacy to maintain or increase body weight of an e-Health application and in-person nutritional counseling compared to standard of care and to each other. Weights were measured in the clinic every 3 months.
次要结局
- Change in Calorie Intake Over Time(Change from baseline over 6 months)
- Safety: Frequency of Adverse Events(From baseline to month 7 (one month after 6 month end of study visit))
- Tolerability: The Number of Participants Who Complete the Study While Complying With at Least 80% of the Counseling Sessions(Baseline, 3 months and 6 months)
研究者
Anne-Marie Alexandra Wills, MD
Assistant Professor of Neurology
Massachusetts General Hospital