Alzheimer DiseaseNCT03384043
Comparing Smartphone Technology and a Memory Strategy on Improving Prospective Memory in Alzheimer's Disease
A study testing Smartphone Personal Assistant and Implementation Intention in people with Alzheimer Disease and Cognitive Impairment, Mild, run by Baylor University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Cognitive Impairment, Mild, Dementia, Mild
- What is being tested?
- Smartphone Personal Assistant and Implementation Intention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Medical Center
Temple, Texas, 76508
About this study
Official title: Using Smartphone Personal Assistant Technology to Improve Prospective Memory in Alzheimer's Disease
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.
- Being tested
- Smartphone Personal Assistant, Implementation Intention
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Personal AssistantBehavioural
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 IntentionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Implementation Intention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Prospective Memory Performance
Performance on the experimenter-assigned time-based and event-based prospective memory tasks (number of tasks completed).
Measured: Measured for 4 weeks.
Secondary outcomes (10)
Quality of Life - Positive Affect and Well-Being
Participants will complete the Quality of Life in Neurological Disorders (Neuro-QOL) subscale titled "Positive Affect and Well-Being." This subscale has 9 items that are rated from Never to Always. The subscale total scores range from 9 (minimum) to 45 (maximum), with higher scores indicating better outcomes
Measured: Pre-Intervention and Post-Intervention (4 weeks)
Quality of Life - Ability to Participate in Social Roles and Activities
Participants will complete the Quality of Life in Neurological Disorders (Neuro-QOL) subscale titled "Ability to Participate in Social Roles and Activities." This subscale has 8 items that are rated from Never to Always. The subscale total scores range from 8 (minimum) to 40 (maximum), with higher scores indicating better outcomes.
Measured: Pre-Intervention and Post-Intervention (4 weeks)
Quality of Life - Satisfaction with Social Roles and Activities
Participants will complete the Quality of Life in Neurological Disorders (Neuro-QOL) subscale titled "Satisfaction with Social Roles and Activities." This subscale has 8 items that are rated from Not at All to Very Much. The subscale total scores range from 8 (minimum) to 40 (maximum), with higher scores indicating better outcomes.
Measured: Pre-Intervention and Post-Intervention (4 weeks)
Quality of Life - Cognitive Function
Participants will complete the Quality of Life in Neurological Disorders (Neuro-QOL) subscale titled "Cognitive Function." This subscale has 8 items. The first four items are rated from Never to Very Often, and the last four items are rated from No Difficulty to Cannot Do. The subscale total scores range from 8 (minimum) to 40 (maximum), with higher scores indicating better outcomes.
Measured: Pre-Intervention and Post-Intervention (4 weeks)
Subjective Memory Performance Questionnaire
The Prospective and Retrospective Memory Questionnaire uses a 5-point scale to assess the frequency of retrospective and prospective memory failures such as forgetting to take a pill.
Measured: Pre-Intervention and Post-Intervention (4 weeks)
Perceived Memory Structured Interview
The experimenter will conduct a structured interview session at baseline to determine participants' most important, common, and challenging prospective memory tasks. At follow-up, participants will rate whether each memory issue described at baseline was much worse (1), worse (2), normal (3), better (4), or much better (5) than usual over the last month.
Measured: Pre-Intervention and Post-Intervention (4 weeks)
Use of Technology/Strategy
The number of times the personal assistant feature and voice-recorder system were used.
Measured: Measured for 4 weeks
Instrumental Activities of Daily Living
Scale on participants' ability to complete instrumental activities of daily living, such as housekeeping, financing, and medication activities.
Measured: Pre-Intervention and Post-Intervention (4 weeks)
Smartphone Acceptability/Usability Scale
Scale to assess the acceptability and usability of the smartphone (Ben Zeev et al., 2014). The scale includes 26 items to which participants respond agree, neutral, or disagree, with agree indicating the favorable outcome on 21 items, and disagree indicating the favorable outcome on 5 items.
Measured: Pre-Intervention and Post-Intervention (4 weeks)
Training Duration
Number of minutes to complete smartphone training
Measured: Pre-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start8 Jan 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Michael Scullin, Baylor University
- Investigators
- Michael Scullin, PhD, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384043
- Sponsor's protocol ID
- 017-327
- Other IDs
- 1R21AG053161-01A1
- Status last verified
- Jul 2020
- First submitted
- 18 Dec 2017
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be shared with any interested researcher who adheres to Health Insurance Portability and Accountability Act (HIPAA) requirements.
Publications
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.
PubMed 24609454
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Smartphone Personal Assistant Technology to Improve Prospective Memory in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03384043
- Acronym / sponsor ID
- 017-327
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone Personal Assistant | Experimental | Behavioral: Smartphone Personal AssistantParticipants 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). |
| Implementation Intention | Active comparator | Behavioral: Implementation IntentionThe 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone Personal AssistantElectronic 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. | Behavioural | Smartphone Personal Assistant |
| Implementation IntentionVerbally 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. | Behavioural | Implementation Intention |
Primary outcome
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).
10 secondary outcomes
Quality of Life - Positive Affect and Well-Being
Time frame: Pre-Intervention and Post-Intervention (4 weeks)
Quality of Life - Ability to Participate in Social Roles and Activities
Time frame: Pre-Intervention and Post-Intervention (4 weeks)
Quality of Life - Satisfaction with Social Roles and Activities
Time frame: Pre-Intervention and Post-Intervention (4 weeks)
Quality of Life - Cognitive Function
Time frame: Pre-Intervention and Post-Intervention (4 weeks)
Subjective Memory Performance Questionnaire
Time frame: Pre-Intervention and Post-Intervention (4 weeks)
Perceived Memory Structured Interview
Time frame: Pre-Intervention and Post-Intervention (4 weeks)
Use of Technology/Strategy
Time frame: Measured for 4 weeks
Instrumental Activities of Daily Living
Time frame: Pre-Intervention and Post-Intervention (4 weeks)
Smartphone Acceptability/Usability Scale
Time frame: Pre-Intervention and Post-Intervention (4 weeks)
Training Duration
Time frame: Pre-Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Background: PubMed 24609454Ben-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.
- Individual participant dataSharing planned: Undecided. De-identified data will be shared with any interested researcher who adheres to Health Insurance Portability and Accountability Act (HIPAA) requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Scullin, PhD principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Personal Assistant and Implementation Intention in people with Alzheimer Disease and Cognitive Impairment, Mild, run by Baylor University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Prospective Memory Performance (time frame: Measured for 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03384043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020; AzTrials last refreshed its copy on 29 Oct 2026.