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临床试验/NCT05016856
NCT05016856已完成不适用

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

Florida State University2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2022年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
2
主要终点
Adherence (session number)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 years of age or older
  • normal or corrected to normal visual acuity
  • must pass a dementia screening

排除标准

  • 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

结局指标

主要结局

Adherence (session number)

时间窗: 6 months

Number of sessions over 6 months

Adherence (session length)

时间窗: 6 months

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

Adherence (holidays)

时间窗: 6 months

Number of extended gaps in between sessions over 6 months

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walter Boot

Principal Investigator

Florida State University

研究点 (2)

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