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

NCT ID: NCT03384043

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2020-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Smartphone Personal Assistant

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).

Group Type: EXPERIMENTAL

Smartphone Personal Assistant

Intervention Type: 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.

Implementation Intention

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).

Group Type: ACTIVE_COMPARATOR

Implementation Intention

Intervention Type: 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.

Interventions

Smartphone Personal Assistant

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.

Intervention Type: BEHAVIORAL

Implementation Intention

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.

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Baylor University

OTHER

Sponsor Role: lead

Responsible Party

Michael Scullin

Assistant Professor of Psychology and Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Scullin, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Locations

Baylor Scott & White Medical Center

Temple, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24609454 (View on PubMed)

Other Identifiers

1R21AG053161-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

017-327

Identifier Type: -

Identifier Source: org_study_id