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临床试验/NCT03384043
NCT03384043已完成不适用

Using Smartphone Personal Assistant Technology to Improve Prospective Memory in Alzheimer's Disease

Baylor University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Objective Prospective Memory Performance

研究概览

简要总结

Alzheimer's disease is a debilitating condition for patients and their caregivers marked by hallmark cognitive symptoms (e.g., memory loss) as well as an impact on quality of life. Researchers and clinicians are learning that a specific type of memory, called prospective memory, may be particularly affected in mild Alzheimer's disease. Prospective memory is memory for future intentions, goals, and chores, and the loss of the neurocognitive processes supporting prospective memory may reduce independent functioning (e.g., medication adherence). The current study investigates a technology-based intervention to assist participants with their daily prospective memory tasks. Participants with mild cognitive impairment and mild Alzheimer's disease will be trained to use a smartphone for four weeks. Smartphone acceptability, usability, and overall user experience will be measured. Furthermore, participants will be tested on completion of daily prospective memory tasks. In one group, participants will train to use the smartphone personal assistant reminder system, which reminds participants of their goals, tasks, and chores at the appropriate time or location. In a comparison group, participants will also carry a smartphone but will train to use a memory strategy in which they verbalize external cues to remind them to perform their goals, tasks, and chores. The goal of this research is to inform whether smartphone technology or a memory strategy can be used to reduce memory burden and improve daily, independent functioning in participants with mild Alzheimer's disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of MCI or dementia at a neurology and/or neuropsychology office visit in the BSWH Temple region, or neuropsychology office visit in the RR BSWH region within 12 months of the study contact (Specific ICD Codes outlined below).
  • •Interest in participating in research
  • •Able and willing to bring a legally authorized representative (spouse or medical power of attorney) to initial training session.
  • •Able to independently consent according to the results of a structured capacity to consent interview OR is interested after going through the consent process but does not pass capacity to consent inventory AND has a legally authorized representative available to provide proxy consent.
  • •Presence of no more than mild dementia on the basis of telephone administered cognitive screening instrument (TICS-M) & Collateral/Informant ADL Measure
  • •o Using the TICS-M and published normative data, all subjects must have scores that are around -1 to -2 standard deviations for demographically corrected norms (National Institute of Aging-Alzheimer's Association recommended criteria for the very mild to mild stages of Alzheimer's disease; Albert et al., 2011; McKhann et al., 2011).
  • •Etiology of the dementia or MCI can be varied or unknown at the time of the screening criteria.

排除标准

  • •Presence of severe cognitive impairment defined by a TICS-M score <-2 standard deviations from the mean.
  • •Semi-structured telephone clinical interview and/or chart review suggest:
  • •Serious mental illness (schizophrenia, bipolar, or depression with suicidal ideation in the last 30 days) are present and significantly contributing to the current presentation
  • •Uncorrected hearing loss, visual loss, or motoric dysfunction would preclude using the smartphone.
  • •English language proficiency (whether due to English as a second language or the presence of aphasia) significantly interferes with completion of telephone screening procedures or would be clinically suspected to interfere with completion of the study process.

研究组 & 干预措施

Smartphone Personal Assistant

Experimental

Participants will use the personal assistant feature of the smartphone ("Cortana") to provide reminders to perform prospective memory tasks at the appropriate time and location. In the current study, participants will press a button and verbally state "Cortana, I need to remember to..." for time--based tasks ("...take my medicine at 7pm") and event--based tasks ("pick-up milk at the grocery store).

干预措施: Smartphone Personal Assistant (Behavioral)

Implementation Intention

Active Comparator

The implementation intention is a memory strategy, in which individuals verbally state when/where they will perform a prospective memory intention. In the current study, participants will verbally specify an external cue in a "When…then" format and record doing so using the smartphone's voice recorder app. They will use the implementation intention strategy for time--based tasks ("When it is 7pm, then I will remember to take my medicine"), and event--based tasks ("When I am at the grocery store, then I will remember to pick--up milk).

干预措施: Implementation Intention (Behavioral)

结局指标

主要结局

Objective Prospective Memory Performance

时间窗: Measured for 4 weeks.

Performance on the experimenter-assigned time-based and event-based prospective memory tasks (number of tasks completed).

次要结局

  • Subjective Memory Performance Questionnaire(Pre-Intervention and Post-Intervention (4 weeks))
  • Perceived Memory Structured Interview(Pre-Intervention and Post-Intervention (4 weeks))
  • Instrumental Activities of Daily Living(Pre-Intervention and Post-Intervention (4 weeks))
  • Training Duration(Pre-Intervention)
  • Quality of Life - Ability to Participate in Social Roles and Activities(Pre-Intervention and Post-Intervention (4 weeks))
  • Quality of Life - Satisfaction with Social Roles and Activities(Pre-Intervention and Post-Intervention (4 weeks))
  • Smartphone Acceptability/Usability Scale(Pre-Intervention and Post-Intervention (4 weeks))
  • Quality of Life - Cognitive Function(Pre-Intervention and Post-Intervention (4 weeks))
  • Use of Technology/Strategy(Measured for 4 weeks)
  • Quality of Life - Positive Affect and Well-Being(Pre-Intervention and Post-Intervention (4 weeks))

研究者

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

Michael Scullin

Assistant Professor of Psychology and Neuroscience

Baylor University

研究点 (1)

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