MEVA Cognitive Wellness Platform Study for Adults (MEVA)

May 18, 2026 updated by: Mentage LLC

Phase 1 Validation Study of the MEVA Cognitive Wellness Platform

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Community-dwelling adults aged 55 to 75 years who are generally healthy or have stable chronic conditions and are interested in cognitive wellness research. Participants are recruited through community-based outreach, including senior centers, libraries, faith-based organizations, wellness programs, and word of mouth. Recruitment is designed to support demographic and socioeconomic diversity.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MEVA Study Cohort
Community-dwelling adults aged 55 to 75 who complete the MEVA digital cognitive wellness battery at baseline. A subset of participants will complete the MEVA battery again approximately 14 days later to assess test-retest reliability.
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.
Other Names:
  • MEVA Mentage Engagement and Vitality Assessment
  • Montessori Engagement and Vitality Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

Intraclass correlation coefficient (ICC) for the MEVA Global Cognitive Index between baseline and retest visits. The Global Cognitive Index is a composite wellness metric derived from performance across four cognitive wellness domains: visuospatial ability, processing speed, language, and executive function.

Reliability will be estimated using ICC(3,1), two-way mixed effects model, absolute agreement, single measurement. Success criterion: ICC point estimate

≥ 0.75 with lower 95% confidence interval bound ≥ 0.60.
Baseline (Visit 1) and retest approximately 14 days later (Visit 2, allowed window 11-17 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Task completion rate
Time Frame: Baseline and 14-day retest (11-17 day window)
Proportion of MEVA digital activities completed without technical errors or participant withdrawal from the activity.
Baseline and 14-day retest (11-17 day window)
Exploratory convergent validity with SLUMS
Time Frame: Baseline (Visit 1)
Pearson correlation between MEVA Global Cognitive Index at baseline and Saint Louis University Mental Status (SLUMS) examination total score.
Baseline (Visit 1)
Exploratory age-stratified score distributions
Time Frame: Baseline (Visit 1)
Descriptive statistics (mean, standard deviation, percentiles) for MEVA Global Cognitive Index and domain composite scores, stratified by age groups within the 55-75 year study population.
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 individual MEVA digital activity scores, measured by the intraclass correlation coefficient (ICC). ICC is a reliability statistic (not a correlation between different measures) ranging from 0 to 1, with higher values indicating greater consistency when the same measure is administered twice. ICC will be calculated using ICC(3,1), a two-way mixed effects model with absolute agreement for single measurements. Each MEVA digital activity generates a numerical performance score at baseline and retest; ICC quantifies the stability of these scores over approximately 14 days.
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)
Test-retest reliability of MEVA domain composite scores, measured by intraclass correlation coefficient (ICC). ICC is a reliability statistic (not a correlation between different measures) ranging from 0 to 1, with higher values indicating greater consistency when the same measure is administered twice. ICC will be calculated using ICC(3,1), a two-way mixed effects model with absolute agreement for single measurements. MEVA generates domain composite scores for four cognitive wellness domains (visuospatial ability, processing speed, language, and executive function) at baseline and retest; ICC quantifies the stability of these domain scores over approximately 14 days.
Baseline and 14-day retest (11-17 day window)
Technology Acceptance Model Questionnaire Subscale Scores
Time Frame: Baseline (Visit 1)
Technology Acceptance Model (TAM) questionnaire scores for perceived usefulness and perceived ease of use of the MEVA platform. Items are rated on a 1 to 7 Likert scale. Subscale scores are calculated as mean item scores ranging from 1 to 7, with higher scores indicating greater perceived usefulness or ease of use.
Baseline (Visit 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mentage LLC

Investigators

  • Principal Investigator: Dwight Bellingham, MD, Bellingham Family Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEVA-P1-2026
  • 26-08-039-2503 (Other Identifier: IRB File Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to small sample size (target n=40 complete test-retest pairs), participant privacy considerations, and proprietary platform development. Aggregate results will be reported in scientific publications and regulatory summaries.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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