An Investigational Study Examining the Efficacy of QbMobile in Treatment Monitoring in Individuals With ADHD
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 175
- 试验地点
- 7
- 主要终点
- Change in QbMobile Total Score from Baseline at Visit 3 and Visit 4
研究概览
简要总结
The current study will investigate if QbMobile can be used to improve the accuracy and objective identification of reduced ADHD symptoms in tests scores once treatment has been initiated.
详细描述
This 4-week study will evaluate QbMobile's performance in monitoring ADHD treatment response. Participants will complete the 10-minute QbMobile test on their personal device during a scheduled clinical visit. They will then repeat the test remotely the following day before beginning their ADHD medication treatment. At week 2 and week 4, participants will take QbMobile remotely at least 1 hour after taking their ADHD medication and no longer than 4 hours post dose.
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
- 6 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent (including parent/legal guardians consent when this is required for individuals under 18 years old and assent as is required based on the age of participant) for QbMobile;
- •Aged > 6 years and < 60 years old;
- •Referred for an ADHD assessment or has a diagnosis of ADHD but not currently receiving any type of stimulant or nonstimulant medication treatment;
- •Meets DSM-5 or ICD-11 criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactivity/impulsive presentation) per sites standard clinical care evaluation;
- •Qbtech Rating Scale total score of >24 at Visit 1;
- •Have adequate sensory and physical ability to complete QbMobile;
- •Possess or has access to an iPhone model that supports QbMobile.
排除标准
- •Intellectual disability designated by IQ<75);
- •Has used psychostimulant medication within 7 days prior to Visit 1;
- •A concurrent medical diagnosis that could significantly affect test performance (brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g., vascular dementia, Alzheimer disease, etc);
- •Other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);
- •Substance use (e.g., alcohol, drugs) that may affect performance on the day of the test.
研究组 & 干预措施
ADHD
干预措施: observational study (Other)
结局指标
主要结局
Change in QbMobile Total Score from Baseline at Visit 3 and Visit 4
时间窗: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)
Change in the QbMobile Total Score from baseline (Visit 2) will be assessed at Visit 3 and Visit 4 to evaluate treatment related responses over time. The QbMobile produces a Total Score number ranging from 0 to 100, where 0 indicates a low likelihood of exhibiting ADHD symptoms and 100 indicates a high likelihood of exhibiting ADHD symptoms. This score is automatically generated in a standard report immediately upon completion of QbMobile.
Change in QbMobile Total Score from Baseline at Visit 3 and Visit 4
时间窗: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)
Change in the QbMobile Total Score from baseline (Visit 2) will be assessed at Visit 3 and Visit 4 to evaluate treatment related responses over time. The QbMobile produces a Total Score number ranging from 0 to 100, where 0 indicates a low likelihood of exhibiting ADHD symptoms and 100 indicates a high likelihood of exhibiting ADHD symptoms. This score is automatically generated in a standard report immediately upon completion of QbMobile.
次要结局
- Change in QbMobile SD-scores from Baseline at Visit 3 and Visit 4(Baseline, Visit 3 (Week 2), and Visit 4 (Week 4))
- Change in QbMobile SD-scores from Baseline at Visit 3 and Visit 4(Baseline, Visit 3 (Week 2), and Visit 4 (Week 4))