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Clinical Trials/NCT05016856
NCT05016856
Completed
Not Applicable

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

Florida State University1 site in 1 country190 target enrollmentNovember 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adherence, Treatment
Sponsor
Florida State University
Enrollment
190
Locations
1
Primary Endpoint
Adherence (session number)
Status
Completed
Last Updated
last year

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).

Registry
clinicaltrials.gov
Start Date
November 7, 2022
End Date
January 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Walter Boot

Principal Investigator

Florida State University

Eligibility Criteria

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

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)

Study Sites (1)

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