NCT06175299

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

December 6, 2023

Last Update Submit

August 6, 2024

Conditions

Keywords

CognitionAdherenceSocial isolation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Adherence (session number)

    2 months

  • Adherence (session length)

    2 months

  • General Self-Efficacy (predictor of adherence)

    Assessed at baseline, predicting adherence variables over 2 months

  • Perceived Training Efficacy (predictor of adherence)

    Assessed at baseline

  • Self-Efficacy of Cognitive Training (predictor of adherence and training outcome)

    Assessed at baseline and at the end of the 2-months of training

Study Arms (1)

Cognitive Training with Social Function

EXPERIMENTAL

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

Interventions

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

Cognitive Training with Social Function

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • Normal or corrected to normal visual acuity
  • Must pass a dementia screening.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Treatment Adherence and ComplianceSocial Isolation

Interventions

4-azido-7-phenylpyrazolo-(1,5a)-1,3,5-triazineDrug Delivery Systems

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Zhe He, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 18, 2023

Study Start

September 30, 2023

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations