NCT07313540

Brief Summary

The objective of this project is to test the feasibility of using a smartphone app in a community setting through collaborating with community-based organizations. The app is called utmbHealthyBrain and it has three activities: (1) drawing, (2) Tai-Chi and meditation, and (3) prayer reading. It also has a "share" function to enable users to interact with their family and friend. These activities can be translated to humans' well-beings such as a more stable emotion, more muscle movement, and better social engagement. This app does not collect any personal data and users are not required to register an account either. The overall study period is 6 weeks including one introduction session (week 1), four weeks of intervention (week 2 to 5), and final feedback session (week 6).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

December 17, 2025

Last Update Submit

March 25, 2026

Conditions

AgingDementiaCognitive Decline

Keywords

SmarthphoneTai-ChiMeditation

Outcome Measures

Primary Outcomes (1)

  • Feasibility of a smartphone app intervention

    Feasibility will be assessed by participant adherence to the smartphone app intervention, defined as completion of activities three times per week.

    3 times per week for 4 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

Twenty pairs of care recipients and caregivers (total: 40 people) will be recruited to the study and required to download the app to their phone and use it three times a week for four weeks. Tools to collect data include (1) one participation log, (2) two mood tests before and after the intervention, and (3) one feedback survey after the intervention.

Behavioral: utmbHealthyBrain Smartphone App

Interventions

utmbHealthyBrain Smartphone AppBEHAVIORAL

a wellness product related to relaxation and stress management and presents a low risk to the safety of users and other persons

Intervention Group

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 50+ who has a primary source of assistance (no age limitation for the caregiver)
  • Both care recipient and caregiver can participate in the study for six weeks in total,
  • Both care recipient and caregiver can read, listen, write, and speak English
  • Both care recipient and caregiver have a personal smartphone.

You may not qualify if:

  • People who are diagnosed with any middle to severe cognitive symptoms (dementia or Alzheimer's Disease) or any psychiatric disease (depression, bipolar, PTSD, Schizophrenia, anxiety disorders, eating disorders)
  • People who are at hospice care
  • People who plan to move out of the current area in one year, and (4) people younger than 50 (but no age limitation for caregivers)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

DementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Wei-Chen Lee, PhD

    University of Texas Medical Branch, Galveston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Chen Lee, PhD

CONTACT

409-747-2649weilee@utmb.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 2, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)