Clinical trial NCT05016856: Smart Reminders to Promote Home-based Cognitive Training
Official title: Adherence Promotion with Person-centered Technology (APPT): Promoting Adherence to Cognitive Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Treatment
Keywords: adherence
cognitive intervention
memory support
artificial intelligence
aging
technology
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 190
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Adherence (session number)
timeFrame: 6 months
measure: Adherence (session length)
timeFrame: 6 months
measure: Adherence (holidays)
timeFrame: 6 months
Secondary outcomes:
measure: Objective Cognition (predictor of adherence)
timeFrame: Assessed at baseline, predicting adherence variables over 6 months
measure: Subjective Cognition (predictor of adherence)
timeFrame: Assessed at baseline, predicting adherence variables over 6 months
measure: Self-Efficacy (predictor of adherence)
timeFrame: Assessed at baseline, predicting adherence variables over 6 months
measure: Technology Proficiency (predictor of adherence)
timeFrame: Assessed at baseline, predicting adherence variables over 6 months
measure: Perceived Training Efficacy (predictor of adherence)
timeFrame: Assessed at baseline, predicting adherence variables over 6 months
measure: Personality (predictor of adherence)
timeFrame: Assessed at baseline, predicting adherence variables over 6 months
measure: Dementia Worry (predictor of adherence)
timeFrame: Assessed at baseline, predicting adherence variables over 6 months
measure: Busyness Scale (predictor of adherence)
timeFrame: Assessed at baseline, predicting adherence variables over 6 months
Other outcomes:
measure: Interview
timeFrame: 6 months
Locations:
city: Tallahassee
country: United States
facility: Department of Psychology, Florida State University
state: Florida
Study officials:
References: