Smart Reminders to Promote Home-based Cognitive Training

NCT05016856 | Completed

• 1 other identifier: STUDY00000064
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether among older adults an adaptive and personalized reminder system can better support adherence to home-based cognitive training over typical reminder systems.

Conditions

Adherence, Treatment

Keywords

adherence; cognitive intervention; memory support; artificial intelligence; aging; technology

Outcome Measures

Primary Outcomes (3)

• Adherence (session number)

  Number of sessions over 6 months

  6 months

• Adherence (session length)

  Number of sessions reaching at least 80% of the assigned session duration over 6 months

  6 months

• Adherence (holidays)

  Number of extended gaps in between sessions over 6 months

  6 months

Secondary Outcomes (8)

• Objective Cognition (predictor of adherence)

  Assessed at baseline, predicting adherence variables over 6 months

• Subjective Cognition (predictor of adherence)

  Assessed at baseline, predicting adherence variables over 6 months

• Self-Efficacy (predictor of adherence)

  Assessed at baseline, predicting adherence variables over 6 months

• Technology Proficiency (predictor of adherence)

  Assessed at baseline, predicting adherence variables over 6 months

• Perceived Training Efficacy (predictor of adherence)

  Assessed at baseline, predicting adherence variables over 6 months

Other Outcomes (1)

• Interview

  6 months

Study Arms (2)

Reminder Only Condition

ACTIVE COMPARATOR

To promote adherence, participants will receive generic reminders when home-based cognitive training has not been completed. This will be in the form of a text message to participants' smart phone.

Behavioral: Standard Reminder System (Active Control)

Smart Adherence Support Condition

EXPERIMENTAL

To promote adherence, participants will receive reminders when home-based cognitive training has not been completed. This will be in the form of a text message to participants' smart phone. In this condition, participants will receive adaptive and tailored reminders based on dynamic algorithms that deploy reminders in a way that considers participant preferences, days and times of previous successful assessments, the success of previous reminder attempts, and answers to brief questions contained within reminder prompts. Parameter weights for these variables will be adjusted dynamically over a 6-month assessment period to ensure that reminders are deployed when they are most likely to be acted upon.

Behavioral: Adherence Promotion With Person-centered Technology (APPT) System

Interventions

Adherence Promotion With Person-centered Technology (APPT) System BEHAVIORAL

A personalized and adaptive text message reminder system.

Smart Adherence Support Condition

Standard Reminder System (Active Control) BEHAVIORAL

A typical text message reminder system.

Reminder Only Condition

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older 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
• blindness or deafness
• severe motor impairment
• not living in the Tallahassee area for the entire 6 month study period
• unable to read at or above 6th grade level

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Department of Psychology, Florida State University

Tallahassee, Florida, 32306-4301, United States

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

4-azido-7-phenylpyrazolo-(1,5a)-1,3,5-triazine; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Measures of adherence will be automatically collected and thus assessors will be blind to this outcome. Data will be coded and analyzed with arbitrary condition markers to mask condition during analysis. Participants will not be explicitly told which condition they are in, but will be aware of the reminder messages they are receiving, and thus are not truly blind.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 23, 2021
• Study Start: November 7, 2022
• Primary Completion: October 31, 2024
• Study Completion: January 1, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available one year after the publication of the first primary outcome paper or two years after the collection of the final participants' data, whichever come first.
• Access Criteria: Data will be freely available online.

Locations

US (1)