The Proactive Screening and Diagnosis of Mild Cognitive Impairment and Depression in Patients Ages 60 and Over: An Implementation Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 960
- Locations
- 1
- Primary Endpoint
- Measure usability of Miro Health assessments (iOS and Android) for patients
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Measure usability of Miro Health assessments (iOS and Android) for patients
Time Frame: 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
Time Frame: Year 1, Q3 - Year 2, Q2
Measure the participant preference for pencil-paper test or Miro Health Mobile Assessment
Secondary Outcomes
- Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment(Year 1, Q1 - Year 2, Q2)