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Clinical Trials/NCT03384043
NCT03384043
Completed
Not Applicable

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

Baylor University1 site in 1 country52 target enrollmentJanuary 8, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Baylor University
Enrollment
52
Locations
1
Primary Endpoint
Objective Prospective Memory Performance
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2018
End Date
February 28, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Scullin

Assistant Professor of Psychology and Neuroscience

Baylor University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Objective Prospective Memory Performance

Time Frame: Measured for 4 weeks.

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

Secondary Outcomes

  • 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))
  • Subjective Memory Performance Questionnaire(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))

Study Sites (1)

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