Alzheimer DiseaseNCT06444841
Paper-Based and Smartphone-Based Memory Supports
A study testing Digital - Google Calendar and Paper-based - Memory Support System in people with Alzheimer Disease and Dementia, Mild, run by Baylor University at 3 sites in United States.
Trial summary
Alzheimer's disease and related dementias lead to marked declines in daily functioning, independence, and quality of life. One of the earliest cognitive changes in these conditions is impairment in prospective memory, or the ability to remember future intentions such as taking medications at a given time. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment
- What is being tested?
- Digital - Google Calendar and Paper-based - Memory Support System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jun 2024to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Demonstrate capacity to consent via structured interview that involves reviewing core study features and probing for understanding of potential benefits/consequences of participating, and understanding that one can withdraw consent at any point, or availability to obtain surrogate consent.
- Clinical features consistent with a diagnosis of MCI or dementia. For clinic-referred participants, available records will be reviewed to ensure the clinical diagnosis meets published diagnostic guidelines. If there is not sufficient documentation for diagnostic purposes, then semi-structured clinical interview and cognitive screening (see below) will be reviewed by clinical staff.
- Cognitive status for inclusion will be assessed by Montreal Cognitive Assessment (MoCA) scores of 17-25 (or 12-18 for the telephone version if in-clinic assessment is not feasible). While some studies suggested that these ranges are appropriate across diverse groups, recent work indicates that adjustment of 1-2 points for different demographics improves instrument sensitivity in disadvantaged groups. The latter approach will be taken.
- Functional status will be assessed via semi-structured interview with the Global Deterioration Scale (GDS), with stage 3 or 4 indicating independence in basic self-maintenance activities.
- Adequate sensory and motor abilities to utilize a smartphone with accommodation.
- Availability of a co-participant who sees the participant at least once a month.
- Co-Participant Inclusion Criteria:
- The co-participant will need to be over the age of 18, consent to participation, and see the participant at least once per month.
Who cannot join
- History of serious mental illness including schizophrenia or bipolar disorder that is judged by the clinician to be the primary cause of cognitive decline.
- Indication of moderate or severe dementia based on clinical documentation, MoCA score, and/or collateral/informant activities of daily living measure during the screening process (GDS score ≥5).
- Language difficulties significant enough to interfere with the screening procedures.
- Uncorrected hearing loss, vision loss, or motor dysfunction significant enough to interfere with training.
- No study partner.
- At the current time, individuals who do not identify as conversational in English will be excluded from participation.
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- Co-Participant Exclusion Criteria:
- Sees participant less than once per month.
- At the current time, individuals who do not identify as conversational in English will be excluded from participation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UT Health Austin Comprehensive Memory Center
Austin, Texas, 78712
Jared Benge, PhD, 512-495-5285, jared.benge@austin.utexas.edu
- Not yet recruiting
Baylor Scott & White Healthcare
Temple, Texas, 76508
Michael Scullin
- Recruiting
Baylor University
Waco, Texas, 76798
Michael Scullin
About this study
Official title: Smartphone-Based Solutions for Prospective Memory in Mild Cognitive Impairment and Dementia
Alzheimer's disease and related dementias lead to marked declines in daily functioning, independence, and quality of life. One of the earliest cognitive changes in these conditions is impairment in prospective memory, or the ability to remember future intentions such as taking medications at a given time. Prior intervention studies that targeted prospective memory used mnemonic strategies or cognitive training, but these approaches resulted in modest gains in clinical populations. By contrast, a Stage I pilot trial indicated that smartphone-based memory aids (reminder apps) can be accepted and used by persons with mild cognitive impairment and mild dementia to improve both subjective and objective prospective memory performance. The investigators will now test for efficacy, durability, and generalizability of benefits across diverse samples in a Stage II randomized controlled trial. Some 200 participants with mild cognitive impairment or mild dementia will be recruited, half of whom will be from digitally-disadvantaged backgrounds (low socioeconomic status, rural, or historically underrepresented groups). Participants will complete baseline assessments and then be randomly assigned to a smartphone reminder app intervention or an active control condition that uses a paper- based memory support system. Across a 4-week intervention period, participants will complete patient-selected and experimenter-assigned prospective memory assessments and receive booster training sessions to promote self-efficacy with the intervention/control system. Durability of effects will be assessed at 3-month and 6-month follow-up sessions. As a secondary aim, study partners will be simultaneously enrolled to collect informant ratings, track how much study partners assist the participants, and determine whether improving prospective memory in patients improves quality of life in study partners (e.g., by reducing the double to-do list burden of remembering for themselves and for care recipients). As a third aim, the investigators will identify barriers and facilitators to smartphone interventions in digitally-disadvantaged individuals who have historically been underrepresented in technology and dementia research.
- Conditions
- Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment
- Being tested
- Digital - Google Calendar, Paper-based - Memory Support System
- Medical subject headings
- Alzheimer Disease, Dementia, Lymphoma, Follicular, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital - Google CalendarBehavioural
Digital calendar apps allow one to digitally "off-load" intentions either by typing them or by speaking them (speech-to-text voice-dictation capabilities). In addition, they deliver automated reminders to perform intended tasks, either at a single time (e.g., Monday at 9 am) or at recurring times (e.g., every night at 8 pm).
Paper-based - Memory Support SystemBehavioural
The Memory Support System is an established paper-based solution for prospective memory functioning. There is considerable evidence in the literature for its utility in mild cognitive impairment (MCI) and it has face validity to patients as supporting memory.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-based app | Experimental | Participants will use Google Calendar, an off-the-shelf app that is free and user-friendly, to provide reminders on their smartphone to perform prospective memory tasks at the appropriate time. In the current study, participants will offload their personal and experimentally assigned tasks into the digital calendar with reminders enabled. Receives: Behavioral: Digital - Google Calendar |
| Paper-based notebook | Active comparator | Participants will use a Memory Support System, which is an established paper-based calendar and note taking system that can fit into one's pocket. In the current study they will use the system to offload personal and experimentally assigned tasks and notes into the schedule, to-do list, and journal sections of the notebook. Receives: Behavioral: Paper-based - Memory Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Prospective Memory Performance
Participants will need to remember to call the study phone number at both 1) regular times each week (set at baseline for the entire study duration), and 2) irregular times each week (experimenter-assigned times that change).
Measured: Measured for 6 months
Patient-Centered/Patient-Selected Prospective Memory Performance
Based on the goal attainment scaling framework; via a structured interview at baseline, the participant and study partner will identify 5-10 activities from the participant's daily routine that require frequent use of prospective memory. At follow-up sessions, participants rate the degree to which each of these personal activities improved or worsened.
Measured: Measured for 6 months
Caregiving-Related Quality of Life
Co-participants will complete the Direct Impact of Care (Scales Measuring the Impact of Dementia on Carers - Direct Impact) scale. This scale has 18 items to which the co-participant respond Agree or Disagree, with Agree responses indicating a greater impact of the care they provide on their own lives.
Measured: Measured for 6 months
Secondary outcomes (19)
Caregiving Cognitive Burden
The Cognitive Burden of Caregiving Scale (CBCS) is a 14 item scale assessing cognitive burden associated with caregiving, strategy use independence and assistance, and time preoccupation. Items are responded to on a 1-7 likert scale (max score of 98) with higher scores indicating greater cognitive burden.
Measured: Measured for 6 months
Calendar Use
Total number of entries for the digital or paper calendar
Measured: Measured for 6 months
Montreal Cognitive Assessment
Participants will complete the Montreal Cognitive Assessment (MoCA), a rapid screening assessment to help detect mild cognitive impairment in numerous cognitive domains (attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation). Scores range from 0 to 30, with lower scores indicating worse outcomes.
Measured: Measured during screening and at 6 months
Smartphone Use - Screen Time
Participants in the digital condition will provide their total minutes of screen time from their phone's settings.
Measured: Measured for 6 months
Smartphone Use - Notifications
Participants in the digital condition will provide the total number of notifications they received, found in their phone's settings.
Measured: Measured for 6 months
Smartphone Use - Pickups
Participants in the digital condition will provide the total number of pickups/unlocks of their phone, found in their phone's settings.
Measured: Measured for 6 months
Smartphone Use - Apps
Participants in the digital condition will provide their most used apps, found in their phone's settings.
Measured: Measured for 6 months
Smartphone Use - Google Calendar
Participants in the digital condition will provide the total amount of time they spent using Google Calendar, found in their phone's settings.
Measured: Measured for 6 months
Prospective and Retrospective Memory Questionnaire - Subjective Memory Functioning
The 21-item Prospective and Retrospective Memory Questionnaire uses a 5-point scale ran to assess the frequency of retrospective and prospective memory failures, such as forgetting to take a pill.
Measured: Measured for 6 months
Modified Functional Activities Questionnaire
Co-Participants will complete a modified instrumental activities of daily living scale to assess participants' ability to independently complete activities of daily living, such as preparing meals or making purchases with analog and digital approaches. The 6-point scale ranges from Normal to Dependent and includes Not Applicable/Unknown response options, with greater scores indicating a greater need of assistance.
Measured: Measured for 6 months
Neuro-QoL - Depression
Participants will complete the Quality of Life in Neurological Disorders (Neuro-QOL) subscale for depression. The subscale has 8 items that are rated from Never to Always. The subscale total score range from 8 (minimum) to 40 (maximum), with lower scores indicating better outcomes.
Measured: Measured for 6 months
Insomnia Severity Index
The 7-item Insomnia Severity Index asks participants to rate the severity of both nighttime and daytime components of their insomnia, with higher scores indicating worse outcomes.
Measured: Measured for 6 months
Everyday Cognition
The Everyday Cognition (ECOG-12) questionnaire uses a 5-point scale to assess the participant's ability to perform certain everyday tasks, such as remembering the current date, rated from "I perform the task much worse than 10 years ago" to "There has been no change in my ability compared to 10 years ago."
Measured: Measured for 6 months
General Life Satisfaction
The National Institutes of Health (NIH) Toolbox General Life Satisfaction questionnaire uses a 7-point scale to assess participants' sense of fulfillment with their lives, with lower scores indicating greater life satisfaction.
Measured: Measured for 6 months
Coping Self-Efficacy
The Coping Self-Efficacy questionnaire uses an 11-point scale - ranging from 0, cannot do at all, to 10, certain can do - assessing the participant's confidence in solving personal or emotional problems.
Measured: Measured for 6 months
Follow-Up Qualitative Interview
Study personnel will conduct semi-structured qualitative interviews with dyads to determine the most helpful, challenging, interesting, and important themes from their experience using their memory strategy.
Measured: Measured at 6 months
Training/Booster Duration
Number of minutes to complete smartphone/memory notebook training
Measured: Measured for 1 month (throughout intervention period)
Self Reported Memory Strategy Use
Self report scale of frequency of using different memory strategies ranging from Never to All the Time, with greater scores indicating more frequent calendar and journal use.
Measured: Measured for 6 months
Self Reported Current Treatments
Self report usage of pharmacological, cognitive, and group therapies.
Measured: Measured for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start27 Jun 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin, Baylor Scott and White Health, 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
- NCT06444841
- Sponsor's protocol ID
- STUDY00004527
- Other IDs
- 1R01AG082783-01
- Status last verified
- Jul 2024
- First submitted
- 21 May 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will use the repository provided by the Global Alzheimer's Association Interactive Network (GAAIN), depositing data within 9 months of publication.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-Based Solutions for Prospective Memory in Mild Cognitive Impairment and Dementia
- ClinicalTrials.gov ID
- NCT06444841
- Acronym / sponsor ID
- STUDY00004527
- Conditions
- Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- University of Texas at Austin, Baylor Scott and White Health, National Institute on Aging (NIA)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 6 Jun 2024 (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 and related dementias lead to marked declines in daily functioning, independence, and quality of life. One of the earliest cognitive changes in these conditions is impairment in prospective memory, or the ability to remember future intentions such as taking medications at a given time. Prior intervention studies that targeted prospective memory used mnemonic strategies or cognitive training, but these approaches resulted in modest gains in clinical populations. By contrast, a Stage I pilot trial indicated that smartphone-based memory aids (reminder apps) can be accepted and used by persons with mild cognitive impairment and mild dementia to improve both subjective and objective prospective memory performance. The investigators will now test for efficacy, durability, and generalizability of benefits across diverse samples in a Stage II randomized controlled trial. Some 200 participants with mild cognitive impairment or mild dementia will be recruited, half of whom will be from digitally-disadvantaged backgrounds (low socioeconomic status, rural, or historically underrepresented groups). Participants will complete baseline assessments and then be randomly assigned to a smartphone reminder app intervention or an active control condition that uses a paper- based memory support system. Across a 4-week intervention period, participants will complete patient-selected and experimenter-assigned prospective memory assessments and receive booster training sessions to promote self-efficacy with the intervention/control system. Durability of effects will be assessed at 3-month and 6-month follow-up sessions. As a secondary aim, study partners will be simultaneously enrolled to collect informant ratings, track how much study partners assist the participants, and determine whether improving prospective memory in patients improves quality of life in study partners (e.g., by reducing the double to-do list burden of remembering for themselves and for care recipients). As a third aim, the investigators will identify barriers and facilitators to smartphone interventions in digitally-disadvantaged individuals who have historically been underrepresented in technology and dementia research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone-based app | Experimental | Behavioral: Digital - Google CalendarParticipants will use Google Calendar, an off-the-shelf app that is free and user-friendly, to provide reminders on their smartphone to perform prospective memory tasks at the appropriate time. In the current study, participants will offload their personal and experimentally assigned tasks into the digital calendar with reminders enabled. |
| Paper-based notebook | Active comparator | Behavioral: Paper-based - Memory Support SystemParticipants will use a Memory Support System, which is an established paper-based calendar and note taking system that can fit into one's pocket. In the current study they will use the system to offload personal and experimentally assigned tasks and notes into the schedule, to-do list, and journal sections of the notebook. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Demonstrate capacity to consent via structured interview that involves reviewing core study features and probing for understanding of potential benefits/consequences of participating, and understanding that one can withdraw consent at any point, or availability to obtain surrogate consent.
- Clinical features consistent with a diagnosis of MCI or dementia. For clinic-referred participants, available records will be reviewed to ensure the clinical diagnosis meets published diagnostic guidelines. If there is not sufficient documentation for diagnostic purposes, then semi-structured clinical interview and cognitive screening (see below) will be reviewed by clinical staff.
- Cognitive status for inclusion will be assessed by Montreal Cognitive Assessment (MoCA) scores of 17-25 (or 12-18 for the telephone version if in-clinic assessment is not feasible). While some studies suggested that these ranges are appropriate across diverse groups, recent work indicates that adjustment of 1-2 points for different demographics improves instrument sensitivity in disadvantaged groups. The latter approach will be taken.
- Functional status will be assessed via semi-structured interview with the Global Deterioration Scale (GDS), with stage 3 or 4 indicating independence in basic self-maintenance activities.
- Adequate sensory and motor abilities to utilize a smartphone with accommodation.
Key exclusion criteria (9 listed)
- History of serious mental illness including schizophrenia or bipolar disorder that is judged by the clinician to be the primary cause of cognitive decline.
- Indication of moderate or severe dementia based on clinical documentation, MoCA score, and/or collateral/informant activities of daily living measure during the screening process (GDS score ≥5).
- Language difficulties significant enough to interfere with the screening procedures.
- Uncorrected hearing loss, vision loss, or motor dysfunction significant enough to interfere with training.
- No study partner.
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 |
|---|---|---|
| Digital - Google CalendarDigital calendar apps allow one to digitally "off-load" intentions either by typing them or by speaking them (speech-to-text voice-dictation capabilities). In addition, they deliver automated reminders to perform intended tasks, either at a single time (e.g., Monday at 9 am) or at recurring times (e.g., every night at 8 pm). | Behavioural | Smartphone-based app |
| Paper-based - Memory Support SystemThe Memory Support System is an established paper-based solution for prospective memory functioning. There is considerable evidence in the literature for its utility in mild cognitive impairment (MCI) and it has face validity to patients as supporting memory. | Behavioural | Paper-based notebook |
Primary outcome
Objective Prospective Memory Performance
Time frame: Measured for 6 months
Participants will need to remember to call the study phone number at both 1) regular times each week (set at baseline for the entire study duration), and 2) irregular times each week (experimenter-assigned times that change).
Patient-Centered/Patient-Selected Prospective Memory Performance
Time frame: Measured for 6 months
Based on the goal attainment scaling framework; via a structured interview at baseline, the participant and study partner will identify 5-10 activities from the participant's daily routine that require frequent use of prospective memory. At follow-up sessions, participants rate the degree to which each of these personal activities improved or worsened.
Caregiving-Related Quality of Life
Time frame: Measured for 6 months
Co-participants will complete the Direct Impact of Care (Scales Measuring the Impact of Dementia on Carers - Direct Impact) scale. This scale has 18 items to which the co-participant respond Agree or Disagree, with Agree responses indicating a greater impact of the care they provide on their own lives.
19 secondary outcomes
Caregiving Cognitive Burden
Time frame: Measured for 6 months
Calendar Use
Time frame: Measured for 6 months
Montreal Cognitive Assessment
Time frame: Measured during screening and at 6 months
Smartphone Use - Screen Time
Time frame: Measured for 6 months
Smartphone Use - Notifications
Time frame: Measured for 6 months
Smartphone Use - Pickups
Time frame: Measured for 6 months
Smartphone Use - Apps
Time frame: Measured for 6 months
Smartphone Use - Google Calendar
Time frame: Measured for 6 months
Prospective and Retrospective Memory Questionnaire - Subjective Memory Functioning
Time frame: Measured for 6 months
Modified Functional Activities Questionnaire
Time frame: Measured for 6 months
Neuro-QoL - Depression
Time frame: Measured for 6 months
Insomnia Severity Index
Time frame: Measured for 6 months
Everyday Cognition
Time frame: Measured for 6 months
General Life Satisfaction
Time frame: Measured for 6 months
Coping Self-Efficacy
Time frame: Measured for 6 months
Follow-Up Qualitative Interview
Time frame: Measured at 6 months
Training/Booster Duration
Time frame: Measured for 1 month (throughout intervention period)
Self Reported Memory Strategy Use
Time frame: Measured for 6 months
Self Reported Current Treatments
Time frame: Measured for 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Yes. The investigators will use the repository provided by the Global Alzheimer's Association Interactive Network (GAAIN), depositing data within 9 months of publication.
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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.
Michael Scullin, PhD principal investigator
Baylor University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital - Google Calendar and Paper-based - Memory Support System in people with Alzheimer Disease and Dementia, Mild, run by Baylor University at 3 sites 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Scullin, PhD (254-710-2251, michael_scullin@baylor.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Prospective Memory Performance (time frame: Measured for 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2024.