NCT07595250

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
May 2026Dec 2026

Study Start

First participant enrolled

May 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 12, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

Cognitive wellnessHealthy agingHealth equityTest-retest reliabilityCommunity-dwelling older adultsPrimary careDigital wellnessOlder adult engagementPsychometricsUsabilityCommunity healthWellness trackingCognitive engagementAdult developmentGeneral wellnessMontessori-informed activitiesTechnology acceptanceExploratory convergent validity

Outcome Measures

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.

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

Secondary Outcomes (6)

  • Task completion rate

    Baseline and 14-day retest (11-17 day window)

  • Exploratory convergent validity with SLUMS

    Baseline (Visit 1)

  • Exploratory age-stratified score distributions

    Baseline (Visit 1)

  • Test-Retest Reliability of Individual MEVA Digital Activity Scores

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

  • Test-Retest Reliability of MEVA Domain Composite Scores

    Baseline and 14-day retest (11-17 day window)

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

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.

Also known as: MEVA Mentage Engagement and Vitality Assessment, Montessori Engagement and Vitality Assessment
MEVA Study Cohort

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dwight Bellingham, MD

    Bellingham Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 19, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.