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Not yet recruiting NCT07313540

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

No phase Interventional Aging Dementia Cognitive Decline

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: utmbHealthyBrain Smartphone App.
Who it may be relevant to
Registry conditions: Aging, Dementia, Cognitive Decline. Basic parameters: 50 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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

Primary outcome measures

  • Feasibility of a smartphone app intervention [Time frame: 3 times per week for 4 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Texas Medical Branch, Galveston — Galveston

Identifiers

NCT: NCT07313540 · 23-0082

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗