Smart Reminders to Promote Home-based Cognitive Training

February 20, 2025 updated by: Walter Boot, Florida State University

Adherence Promotion with Person-centered Technology (APPT): Promoting Adherence to Cognitive Intervention

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.

Study Overview

Detailed Description

Many cognitive training interventions are associated with poor adherence, and poor adherence is associated with fewer benefits. Further, poor adherence in cognitive intervention studies can interfere with answering fundamental questions regarding intervention efficacy. This study will compare the effects of non-adaptive and smart adherence support systems. Participants will be asked to engage in frequent home-based cognitive training on a computer tablet. In the smart adherence support 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 engagement, 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. This study will investigate adherence to training sessions, multiple times each week for 6 months, representing a large challenge to adherence. Participants will be randomly assigned to one condition or another, and adherence at home will be monitored. This will be an Individually Randomized Group-Treatment Trial (IRGT).

Study Type

Interventional

Enrollment (Actual)

190

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

    • Florida
      • Tallahassee, Florida, United States, 32306-4301
        • Department of Psychology, 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

65 years and older (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
  • 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

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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reminder Only Condition
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.
A typical text message reminder system.
Experimental: Smart Adherence Support Condition
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.
A personalized and adaptive text message reminder system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence (session number)
Time Frame: 6 months
Number of sessions over 6 months
6 months
Adherence (session length)
Time Frame: 6 months
Number of sessions reaching at least 80% of the assigned session duration over 6 months
6 months
Adherence (holidays)
Time Frame: 6 months
Number of extended gaps in between sessions over 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Cognition (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
A composite measure of objective cognitive ability
Assessed at baseline, predicting adherence variables over 6 months
Subjective Cognition (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
A composite measure of subjective cognitive deficit
Assessed at baseline, predicting adherence variables over 6 months
Self-Efficacy (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
A composite measure of self-efficacy (beliefs held about ability to complete tasks)
Assessed at baseline, predicting adherence variables over 6 months
Technology Proficiency (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
A composite measure of proficiency with technology
Assessed at baseline, predicting adherence variables over 6 months
Perceived Training Efficacy (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
A composite measure of belief in the the efficacy of cognitive training
Assessed at baseline, predicting adherence variables over 6 months
Personality (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
Measure of stable traits
Assessed at baseline, predicting adherence variables over 6 months
Dementia Worry (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
A composite measure of anxiety over cognitive decline
Assessed at baseline, predicting adherence variables over 6 months
Busyness Scale (predictor of adherence)
Time Frame: Assessed at baseline, predicting adherence variables over 6 months
Self-reported environmental demands of day-to-day life
Assessed at baseline, predicting adherence variables over 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interview
Time Frame: 6 months
Interview assessing experience in study
6 months

Collaborators and Investigators

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

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)

November 7, 2022

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified adherence data (time and date of intervention engagement) and scored individual difference measures (at the level of the individual) will be shared online.

IPD Sharing 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.

IPD Sharing Access Criteria

Data will be freely available online.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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