Comparing Smartphone Technology and a Memory Strategy on Improving Prospective Memory in Alzheimer's Disease

NCT03384043 | Completed

• 2 other identifiers: 017-3271R21AG053161-01A1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Cognitive Impairment, Mild; Dementia, Mild

Outcome Measures

Primary Outcomes (1)

• Objective Prospective Memory Performance

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

  Measured for 4 weeks.

Secondary Outcomes (10)

• Quality of Life - Positive Affect and Well-Being

  Pre-Intervention and Post-Intervention (4 weeks)

• 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)

• Quality of Life - Cognitive Function

  Pre-Intervention and Post-Intervention (4 weeks)

• Subjective Memory Performance Questionnaire

  Pre-Intervention and Post-Intervention (4 weeks)

Study Arms (2)

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).

Behavioral: Smartphone Personal Assistant

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).

Behavioral: Implementation Intention

Interventions

Smartphone Personal Assistant BEHAVIORAL

Electronic memory aids (e.g., pagers) are known to support memory for goals and intentions (prospective memory) in individuals with cognitive impairment. Smartphone technology has the potential to enhance the benefits of previous electronic memory aids because they can provide reminders not only at the correct time, but also at the correct location.

Smartphone Personal Assistant

Implementation Intention BEHAVIORAL

Verbally specifying when and where one intends to complete a goal or action (prospective memory) is known to improve the likelihood of later completing that prospective memory. The implementation intention is the best known memory strategy for prospective memory in patients with mild cognitive impairment.

Implementation Intention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Baylor Scott & White Medical Center

Temple, Texas, 76508, United States

Location

Related Publications (1)

• Ben-Zeev D, Brenner CJ, Begale M, Duffecy J, Mohr DC, Mueser KT. Feasibility, acceptability, and preliminary efficacy of a smartphone intervention for schizophrenia. Schizophr Bull. 2014 Nov;40(6):1244-53. doi: 10.1093/schbul/sbu033. Epub 2014 Mar 8.

  PMID: 24609454 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michael Scullin, PhD

  Baylor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology and Neuroscience

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 27, 2017
• Study Start: January 8, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

US (1)