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Completed

NCT Number: NCT06175299

Social Functions to Promote 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.

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Key information

Conditions

Adherence, Treatment Behavior Health Behavior Social Behavior Social Isolation Treatment Adherence and Compliance

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adherence Promotion With Person-centered Technology (APPT) System with Social Functions

Behavioral

The system has seven games for cognitive training and two social interactions functions: a chat function and a leaderboard function.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Adherence (session number)

    Time frame: 2 months

    Number of sessions over 2 months

  2. Adherence (session length)

    Time frame: 2 months

    Number of sessions reaching at least 80% of the assigned session duration over 2 months

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Acronym: DeepCare

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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