Social Functions to Promote Home-based Cognitive Training (DeepCare)

August 6, 2024 updated by: Zhe He, Florida State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Florida State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Training with Social Function
To promote adherence and reduce social isolation, participants will be asked to use home-based cognitive training program on a tablet for 30 minutes per day for 5 days a week for 1 month, then use it freely for another month. The cognitive training program has a chat function and a leadership board to allow interaction between participants.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Three-Item Loneliness Scale
Time Frame: Assessed at baseline and at the end of the 2-months of training
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence (session number)
Time Frame: 2 months
Number of sessions over 2 months
2 months
Adherence (session length)
Time Frame: 2 months
Number of sessions reaching at least 80% of the assigned session duration over 2 months
2 months
General Self-Efficacy (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 2 months
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
Perceived Training Efficacy (predictor of adherence)
Time Frame: Assessed at baseline
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
Self-Efficacy of Cognitive Training (predictor of adherence and training outcome)
Time Frame: Assessed at baseline and at the end of the 2-months of training
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Investigators

  • Principal Investigator: Zhe He, PhD, Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FSU00004067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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