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Clinical Trials/NCT05016856
NCT05016856CompletedNot Applicable

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

Florida State University1 site in 1 country190 target enrollmentStarted: November 7, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
190
Locations
1
Primary Endpoint
Adherence (session number)

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Basic Science
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Standard Reminder System (Active Control) (Behavioral)

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.

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

Outcomes

Primary Outcomes

Adherence (session number)

Time Frame: 6 months

Number of sessions over 6 months

Adherence (session length)

Time Frame: 6 months

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

Adherence (holidays)

Time Frame: 6 months

Number of extended gaps in between sessions over 6 months

Secondary Outcomes

  • Personality (predictor of adherence)(Assessed at baseline, predicting adherence variables over 6 months)
  • Objective Cognition (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)
  • Dementia Worry (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)
  • Subjective Cognition (predictor of adherence)(Assessed at baseline, predicting adherence variables over 6 months)
  • Busyness Scale (predictor of adherence)(Assessed at baseline, predicting adherence variables over 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Walter Boot

Principal Investigator

Florida State University

Study Sites (1)

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