Clinical trial NCT03384043: Comparing Smartphone Technology and a Memory Strategy on Improving Prospective Memory in Alzheimer's Disease
Official title: Using Smartphone Personal Assistant Technology to Improve Prospective Memory in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Cognitive Impairment, Mild
Dementia, Mild
Lead sponsor: Baylor University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-12-27
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Objective Prospective Memory Performance
timeFrame: Measured for 4 weeks.
Secondary outcomes:
measure: Quality of Life - Positive Affect and Well-Being
timeFrame: Pre-Intervention and Post-Intervention (4 weeks)
measure: Quality of Life - Ability to Participate in Social Roles and Activities
timeFrame: Pre-Intervention and Post-Intervention (4 weeks)
measure: Quality of Life - Satisfaction with Social Roles and Activities
timeFrame: Pre-Intervention and Post-Intervention (4 weeks)
measure: Quality of Life - Cognitive Function
timeFrame: Pre-Intervention and Post-Intervention (4 weeks)
measure: Subjective Memory Performance Questionnaire
timeFrame: Pre-Intervention and Post-Intervention (4 weeks)
measure: Perceived Memory Structured Interview
timeFrame: Pre-Intervention and Post-Intervention (4 weeks)
measure: Use of Technology/Strategy
timeFrame: Measured for 4 weeks
measure: Instrumental Activities of Daily Living
timeFrame: Pre-Intervention and Post-Intervention (4 weeks)
measure: Smartphone Acceptability/Usability Scale
timeFrame: Pre-Intervention and Post-Intervention (4 weeks)
measure: Training Duration
timeFrame: Pre-Intervention
Other outcomes:
Locations:
city: Temple
country: United States
facility: Baylor Scott & White Medical Center
state: Texas
Study officials:
affiliation: Baylor University
name: Michael Scullin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.