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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06175299
Other study ID # FSU00004067
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2023
Est. completion date July 30, 2024

Study information

Verified date December 2023
Source Florida State University
Contact Zhe He, PhD
Phone 8506445775
Email zhe@fsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will examine whether among older adults social interaction functions in a home-based cognitive training program can better support adherence to training and reduce social isolation.


Description:

The goal of this project is to conduct a pilot study to test the feasibility of two new features, a chat function and a leaderboard function, to encourage social interactions and support adherence to cognitive training protocols (mental exercises delivered via a tablet) over a period of time (2 months), and uncover individual difference factors that can predict poor adherence in the future and social interactions in the game. Even effective cognitive interventions may fail if individuals do not adhere to them for an extended period. This project will compare cognitive training games with chat function and leaderboard in reducing social isolation and improving adherence to the training, compared to an external control group using a generic reminder system delivered via smartphone text messages to promote adherence. The ultimate goal, as effective technology-based interventions to improve cognition become available, is to help support their benefit for older adults by maximizing long-term adherence.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria: - 65 years of age or older - Normal or corrected to normal visual acuity - Must pass a dementia screening. Exclusion Criteria: - Parkinson's, Alzheimer's disease, or any other neurodegenerative disease - Terminal illness - Severe motor impairment - Not living in the Tallahassee area for the entire 6 month study period

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Adherence Promotion With Person-centered Technology (APPT) System with Social Functions
The system has seven games for cognitive training and two social interactions functions: a chat function and a leaderboard function.

Locations

Country Name City State
United States Florida State University Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Three-Item Loneliness Scale The Three-Item Loneliness Scale was developed by Hughes et al. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2394670/). The minimum value is 3. The maximum value is 9. Higher scores mean more loneliness. Assessed at baseline and at the end of the 2-months of training
Secondary Adherence (session number) Number of sessions over 2 months 2 months
Secondary Adherence (session length) Number of sessions reaching at least 80% of the assigned session duration over 2 months 2 months
Secondary General Self-Efficacy (predictor of adherence) The 10-item General Self-Efficacy Scale (GSE) was developed by Ralf Schwarzer & Matthias Jerusalem (http://userpage.fu-berlin.de/~health/engscal.htm). The minimum value is 10. The minimum value is 40. Higher scores mean higher general self-efficacy. Assessed at baseline, predicting adherence variables over 2 months
Secondary Perceived Training Efficacy (predictor of adherence) The 7-item Cognitive Training Belief Scale (NICT scale) measures perceived usefulness of brain training. It was developed by Rabipour & Davidson in 2015 (https://pubmed.ncbi.nlm.nih.gov/25591472/). The minimum value is 7. The maximum value is 49. High scores mean higher expectations of brain training efficacy. Assessed at baseline
Secondary Self-Efficacy of Cognitive Training (predictor of adherence and training outcome) The 12-item Self-Efficacy of Cognitive Training is a composite measure of self-efficacy of cognitive training based on the Health Belief Model. The minimum value is 12. The maximum value is 84. Higher scores mean lower confidence in computerized cognitive training. Assessed at baseline and at the end of the 2-months of training
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