MEVA Cognitive Wellness Platform Study for Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MEVA Cognitive Wellness Platform.
- Who it may be relevant to
- Registry conditions: Cognitive Wellness, Healthy Aging, Age-Related Cognitive Change, Aging. Basic parameters: 55 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase 1 Validation Study of the MEVA Cognitive Wellness Platform
Overview
The goal of this observational study is to evaluate the reliability, usability, and feasibility of the MEVA Cognitive Wellness Platform in community-dwelling adults aged 55 to 75. The main questions it aims to answer are: How consistent is the MEVA Global Cognitive Index when participants complete the MEVA activities again approximately 14 days later? How usable and acceptable is the MEVA platform for older adults in community settings? What completion rates, data quality patterns, and participant feedback are observed during use of the platform? Participants will: Complete a baseline study visit lasting approximately 45 to 60 minutes Complete a 7-activity digital cognitive wellness battery Answer questionnaires about usability, technology acceptance, and wellness experience Complete the Saint Louis University Mental Status (SLUMS) examination as an exploratory comparison measure If selected for the retest group, return approximately 14 days later to complete the MEVA activities again MEVA is being evaluated as a cognitive wellness platform. It is not intended to diagnose, treat, prevent, screen for, or monitor any disease or medical condition.
Detailed description
This is a prospective, single-center, observational psychometric validation study of the MEVA Cognitive Wellness Platform in community-dwelling adults aged 55 to 75.
Platform Overview MEVA is a digital cognitive wellness platform developed by Mentage LLC to support cognitive engagement and healthy aging. MEVA uses real-world, Montessori-informed digital activities designed for older adult usability, autonomy, and engagement. The platform is not intended to diagnose, treat, prevent, screen for, or monitor any disease or medical condition, and is not used for clinical decision-making.
Study Purpose The primary objective is to evaluate test-retest reliability of the MEVA Global Cognitive Index over approximately 14 days. Secondary objectives include assessing usability, feasibility, task completion rates, internal consistency, participant experience, and exploratory convergent validity with an established cognitive measure.
Study Design All enrolled participants complete a baseline visit including informed consent, eligibility confirmation, demographic and health questionnaires, the PHQ-4 distress screening, the MEVA 7-activity digital cognitive wellness battery, the Saint Louis University Mental Status (SLUMS) examination, System Usability Scale, Technology Acceptance Model questionnaire, and brief qualitative feedback. The baseline visit lasts approximately 45 to 60 minutes.
The MEVA battery includes seven digital activities across four cognitive wellness domains: visuospatial ability, processing speed, language, and executive function. Performance across activities is combined into domain composite scores, which are then combined into the MEVA Global Cognitive Index, a composite wellness metric.
A randomly selected subset of participants (approximately 48 to 50) will complete a second visit approximately 14 days after baseline (allowed window: 11 to 17 days). At the retest visit, participants repeat the MEVA battery and complete a brief satisfaction questionnaire. The retest visit lasts approximately 30 to 35 minutes.
Recruitment and Health Equity Considerations Recruitment is community-based, including senior centers, libraries, faith-based organizations, wellness programs, and word of mouth. Recruitment is designed to support demographic and socioeconomic diversity. The study includes exploratory descriptive analyses examining MEVA performance, usability, and participant experience across age, education, technology experience, and self-reported health status to inform future culturally responsive wellness platform development.
Outcomes The primary outcome is test-retest reliability of the MEVA Global Cognitive Index, measured by intraclass correlation coefficient (ICC). Success is defined as ICC point estimate ≥ 0.75 with lower 95% confidence interval bound ≥ 0.60.
Secondary and exploratory outcomes include domain-level reliability, activity-level reliability, internal consistency (Cronbach's alpha, McDonald's omega), System Usability Scale score, Technology Acceptance Model scores, task completion rates, validity flag frequency, practice effects between visits, exploratory correlation with SLUMS total score, and exploratory age-stratified wellness score distributions.
Provisional Wellness Feedback Participants may receive provisional wellness feedback during or after MEVA completion. Any feedback is for research and wellness purposes only. It is not a medical assessment, diagnosis, screening result, treatment recommendation, or clinical interpretation.
Study Rationale This study provides foundational psychometric evidence to support MEVA's use as a wellness engagement tool in community and primary care settings. Findings will inform future validation studies in larger, more diverse populations and explore MEVA's potential role in health equity research and community-based cognitive wellness initiatives.
Interventions
- Behavioral MEVA Cognitive Wellness Platform
Participants complete an activity digital cognitive wellness battery designed to evaluate reliability, usability, feasibility, participant experience, and data quality. MEVA is being evaluated as a general wellness platform and is not used to diagnose, treat, prevent, screen for, or monitor any disease or medical condition.
Primary outcome measures
- Test-retest reliability of the MEVA Global Cognitive Index [Time frame: Baseline (Visit 1) and retest approximately 14 days later (Visit 2, allowed window 11-17 days)]
Secondary outcome measures (6)
- Task completion rate [Time frame: Baseline and 14-day retest (11-17 day window)]
- Exploratory convergent validity with SLUMS [Time frame: Baseline (Visit 1)]
- Exploratory age-stratified score distributions [Time frame: Baseline (Visit 1)]
- Test-Retest Reliability of Individual MEVA Digital Activity Scores [Time frame: Baseline (Visit 1) and retest approximately 14 days later (Visit 2, allowed window 11-17 days)]
- Test-Retest Reliability of MEVA Domain Composite Scores [Time frame: Baseline and 14-day retest (11-17 day window)]
- Technology Acceptance Model Questionnaire Subscale Scores [Time frame: Baseline (Visit 1)]
Eligibility criteria
Inclusion criteria
- Adults aged 55 to 75 years
- Community-dwelling (living independently in the community)
- English fluency sufficient for informed consent, task instructions, and questionnaires
- Able to provide informed consent using teach-back method
- Able to use a computer or tablet for simple tap or drag interactions
- Functional vision sufficient for on-screen tasks with usual corrective lenses
- Functional hearing sufficient for spoken instructions with or without hearing aids
- Interest in cognitive wellness and personal well-being
- Available for baseline visit and possible retest visit approximately 14 days later
- Transportation to study site or ability to participate remotely if permitted by protocol
- Assistive devices and accommodations are permitted
Exclusion criteria
- Severe visual impairment preventing completion of digital tasks
- Severe motor impairment preventing interaction with tablet or web application
- Known diagnosis of moderate or severe dementia, or inability to comprehend consent and task instructions
- Current participation in another cognitive training or technology intervention study likely to confound outcomes
- Recent hospitalization, emergency room visit, or acute exacerbation of a medical or psychiatric condition within the past 30 days that would impede study participation
- Current substance use disorder likely to interfere with study adherence or completion
- Recent intensive use of a similar structured cognitive wellness or brain training application
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07595250 · MEVA-P1-2026 · 26-08-039-2503