跳至主要内容
临床试验/NCT06011681
NCT06011681招募中不适用

The Proactive Screening and Diagnosis of Mild Cognitive Impairment and Depression in Patients Ages 60 and Over: An Implementation Study

Miro Health1 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2023年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
960
试验地点
1
主要终点
Measure usability of Miro Health assessments (iOS and Android) for patients

研究概览

简要总结

Mild cognitive impairment (MCI) leading to Alzheimer's disease and related disorders (ADRD) represents a significant health and economic burden of the rapidly expanding senior population. The accurate detection and diagnosis of MCI and its common comorbidity, late-life depression (LLD), is essential for prolonging patient quality of life and developing advancements in research and treatment options. The purpose of the proposed program is to refine Miro Health's A.I. to accurately detect, differentiate and diagnose MCI and LLD.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • LLD: Age 60 or over; diagnosis of LLD or symptoms consonant with LLD; PHQ-9 score from 15 to 27
  • MCI: Age 60 or over; diagnosis of MCI or self-reported insidious onset and continued worsening of cognitive decline; intact activities of daily living
  • HC: Age 60 or over

排除标准

  • Age 59 or younger; history of unresolved neurological or psychiatric conditions; current medications known to affect cognition; history of substance abuse; unable to perform activities of daily living; change in employment status due to condition

结局指标

主要结局

Measure usability of Miro Health assessments (iOS and Android) for patients

时间窗: Year 1, Q3 - Year 2, Q2

Measure the (a) time point 1 in-assessment drop-out rate; and (b) the rate of lost-to-time-point-2-followup at 12 months.

Measure acceptability of Miro Health assessments (iOS and Android) for patients

时间窗: Year 1, Q3 - Year 2, Q2

Measure the participant preference for pencil-paper test or Miro Health Mobile Assessment

次要结局

  • Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment(Year 1, Q1 - Year 2, Q2)

研究者

发起方
Miro Health
申办方类型
Other
责任方
Sponsor

研究点 (1)

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