Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- AIMS Score
研究概览
简要总结
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.
详细描述
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia. Participants will all be taking an antipsychotic medication and half will have a diagnosis of Tardive Dyskinesia and half will not. Participant responses to interview questions and elements of the Abnormal Involuntary Movement Scale will be collected on video. The videos will be rated by trained observers. Machine learning methods will be used to develop an algorithm to detect abnormal movements in individuals with a known Tardive Dyskinesia diagnosis. The trained rater results will be compared to the algorithm to determine the accuracy of the algorithm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •For the non-TD group:
- •Prescribed and taking an antipsychotic medication for 90-days or longer.
- •Tardive Dyskinesia symptoms if present are not from Parkinsons, Tourette's syndrome, Huntington disease.
- •Signed an informed consent.
- •Speaks English fluently.
排除标准
- •Suffered a moderate or severe head injury in the last year;
- •History of a learning disorder or developmental disability that would inhibit a patient from completing the TD protocol.
- •Severe visual impairment that is cannot be corrected by glasses or contacts.
研究组 & 干预措施
Taking antipsychotic medication with Tardive Dyskinesia
干预措施: TDtect (Other)
Taking antipsychotic medication without Tardive Dyskinesia
干预措施: TDtect (Other)
结局指标
主要结局
AIMS Score
时间窗: Baseline
Abnormal Involuntary Scale Score
次要结局
未报告次要终点