MEVA Cognitive Wellness Platform Study for Adults

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-75
SponsorMentage LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MEVA Cognitive Wellness Platform

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: MEVA Study Cohort1 intervention

Trial outcomes

Primary outcomes

1

Test-retest reliability of the MEVA Global Cognitive Index

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.

Time frame
Baseline (Visit 1) and retest approximately 14 days later (Visit 2, allowed window 11-17 days)

Secondary outcomes

1

Task completion rate

Proportion of MEVA digital activities completed without technical errors or participant withdrawal from the activity.

Time frame
Baseline and 14-day retest (11-17 day window)
2

Exploratory convergent validity with SLUMS

Pearson correlation between MEVA Global Cognitive Index at baseline and Saint Louis University Mental Status (SLUMS) examination total score.

Time frame
Baseline (Visit 1)
3

Exploratory age-stratified score distributions

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.

Time frame
Baseline (Visit 1)
4

Test-Retest Reliability of Individual MEVA Digital Activity Scores

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.

Time frame
Baseline (Visit 1) and retest approximately 14 days later (Visit 2, allowed window 11-17 days)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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