Feasibility of A Smartphone Application Intervention in Community Settings: A Pretest-Posttest Pilot Study

NCT ID: NCT07313540

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

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).

Detailed Description

This study will conduct primary data collection on 20 individuals aged 50+ and another 20 who are their caregivers regarding the use of a smartphone application (app) to promote mental well-being. The aging population is growing rapidly from 52 million in 2018 to 95 million by 2060. Approximately 34.2 million Americans have provided unpaid care to an adult age 50 or older. While 82% of them care for one adult, about 15% care for 2 adults and 3% for 3 or more adults. This number is expected to increase as the population ages. Deteriorating health of care recipients and caregivers is a critical issue that may be delayed by the use of a smartphone app to improve mental and emotional well-beings.

The objective of this proposed project is through collaborating with community-based organizations to test the acceptability and feasibility of a smartphone app intervention. We will collaborate with the community-based organization (i.e., UTMB OLLI and Libbie's Place) to announce the study by flyers and request RSVP to the study investigator. The investigator will provide instructions on using the smartphone app to potential participants and obtain participant's written consent to the study. After consenting, 20 pairs of older adults and their caregivers will fill out a mood test, download the app to their phone, and use it at least three times a week for four weeks. Participants will be required to keep their utilization log and fill out the post-intervention mood test and the feedback survey after four weeks of participation.

Conditions

Aging; Dementia; Cognitive Decline

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

utmbHealthyBrain Smartphone App

Intervention Type: BEHAVIORAL

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

Interventions

utmbHealthyBrain Smartphone App

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Individuals aged 50+ who has a primary source of assistance (no age limitation for the caregiver)

2. Both care recipient and caregiver can participate in the study for six weeks in total,

3. Both care recipient and caregiver can read, listen, write, and speak English

4. Both care recipient and caregiver have a personal smartphone.

Exclusion Criteria

1. 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)

2. People who are at hospice care

3. 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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei-Chen Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch, Galveston

Locations

University of Texas Medical Branch, Galveston

Galveston, Texas, United States

Countries

United States

Central Contacts

Wei-Chen Lee, PhD

Role: CONTACT

weilee@utmb.edu

409-747-2649

Facility Contacts

Wei-Chen Lee, PhD

Role: primary

weilee@utmb.edu

409-747-2649

Other Identifiers

23-0082

Identifier Type: -

Identifier Source: org_study_id