Smart Reminders to Promote Home-based Cognitive Training

NCT ID: NCT05016856

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2025-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adherence, Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Standard Reminder System (Active Control)

Intervention Type BEHAVIORAL

A typical text message reminder system.

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.

Group Type EXPERIMENTAL

Adherence Promotion With Person-centered Technology (APPT) System

Intervention Type BEHAVIORAL

A personalized and adaptive text message reminder system.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adherence Promotion With Person-centered Technology (APPT) System

A personalized and adaptive text message reminder system.

Intervention Type BEHAVIORAL

Standard Reminder System (Active Control)

A typical text message reminder system.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Florida State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Walter Boot

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychology, Florida State University

Tallahassee, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00000064

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Caring for the Caregiver Network
NCT03049501 COMPLETED NA