Longitudinal Endpoint Assessment of Disease Burden in HD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Assess the ability to consent and enroll
研究概览
简要总结
LEAD-HD is intended to collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD participating in a 24-month longitudinal natural history study using remote technologies.
详细描述
The LEAD-HD study will be offered via HSG's online observational research platform called myHDstory®. This direct to patient study will collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD in a 24-month longitudinal natural history study that participants complete at any time and with their own electronic device.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age or older;
- •Be willing and able to provide informed consent electronically;
- •Self-report, when answering as a participant, that you have been diagnosed with HD by a doctor, or have undergone genetic testing and been found to carry the gene mutation responsible for HD but have not been clinically diagnosed with HD (prodromal HD);
- •Have the ability to answer online questions or direct someone else to enter answers for them;
- •Have the ability to ambulate independently and take care of some of your personal needs;
- •Have the ability to read and understand English;
- •Be willing to create a unique identifier based on personal demographic information;
- •Reside in the United States or its territories. Surveys can only be completed in the US. If you move outside of the US, you will no longer be able to participate;
- •Own or have access to an electronic device and secure internet connectivity
排除标准
- 未提供
结局指标
主要结局
Assess the ability to consent and enroll
时间窗: December 2026
Assess the ability to consent and enroll participants in long-term longitudinal studies in HD using a direct-to-patient platform.
Demographic characteristics
时间窗: December 2026
Identify demographic characteristics that are associated with faster or slower disease progression.
PRO natural history
时间窗: December 2026
Obtain PRO natural history data in HD.
次要结局
未报告次要终点