Smart Reminders to Promote Home-based Cognitive Training

Adherence, Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05016856
• Other study ID #: STUDY00000064
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: Florida State University
• Contact: Walter Boot, PhD
• Phone: 850 645-8734
• Email: boot[@]psy.fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: January 1, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Treatment

Intervention

Behavioral:
• Adherence Promotion With Person-centered Technology (APPT) System
A personalized and adaptive text message reminder system.
• Standard Reminder System (Active Control)
A typical text message reminder system.

Locations

Country	Name	City	State
United States	Department of Psychology, Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interview	Interview assessing experience in study	6 months
Primary	Adherence (session number)	Number of sessions over 6 months	6 months
Primary	Adherence (session length)	Number of sessions reaching at least 80% of the assigned session duration over 6 months	6 months
Primary	Adherence (holidays)	Number of extended gaps in between sessions over 6 months	6 months
Secondary	Objective Cognition (predictor of adherence)	A composite measure of objective cognitive ability	Assessed at baseline, predicting adherence variables over 6 months
Secondary	Subjective Cognition (predictor of adherence)	A composite measure of subjective cognitive deficit	Assessed at baseline, predicting adherence variables over 6 months
Secondary	Self-Efficacy (predictor of adherence)	A composite measure of self-efficacy (beliefs held about ability to complete tasks)	Assessed at baseline, predicting adherence variables over 6 months
Secondary	Technology Proficiency (predictor of adherence)	A composite measure of proficiency with technology	Assessed at baseline, predicting adherence variables over 6 months
Secondary	Perceived Training Efficacy (predictor of adherence)	A composite measure of belief in the the efficacy of cognitive training	Assessed at baseline, predicting adherence variables over 6 months
Secondary	Personality (predictor of adherence)	Measure of stable traits	Assessed at baseline, predicting adherence variables over 6 months
Secondary	Dementia Worry (predictor of adherence)	A composite measure of anxiety over cognitive decline	Assessed at baseline, predicting adherence variables over 6 months
Secondary	Busyness Scale (predictor of adherence)	Self-reported environmental demands of day-to-day life	Assessed at baseline, predicting adherence variables over 6 months