Social Functions to Promote Home-based Cognitive Training

Social Isolation Clinical Trial

— DeepCare  

Official title:

Evaluating the Social Functions to Promote the Adherence and Reduce Social Isolation in Home-based Cognitive Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06175299
• Other study ID #: FSU00004067
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adherence, Treatment
• Social Isolation

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