Paper-Based and Smartphone-Based Memory Supports

July 8, 2024 updated by: Michael Scullin, Baylor University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • Recruiting
        • UT Health Austin Comprehensive Memory Center
        • Contact:
      • Temple, Texas, United States, 76508
        • Not yet recruiting
        • Baylor Scott & White Healthcare
        • Contact:
          • Michael Scullin
      • Waco, Texas, United States, 76798
        • Recruiting
        • Baylor University
        • Contact:
          • Michael Scullin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Smartphone-based app
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.
Behavioral: Digital - Google Calendar
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).
Active Comparator: Paper-based notebook
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.
Behavioral: Paper-based - Memory Support System
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Measured for 6 months
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.
Measured for 6 months
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.
Measured for 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caregiving Cognitive Burden
Time Frame: Measured for 6 months
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 for 6 months
Calendar Use
Time Frame: Measured for 6 months
Total number of entries for the digital or paper calendar
Measured for 6 months
Smartphone Use - Screen Time
Time Frame: Measured for 6 months
Participants in the digital condition will provide their total minutes of screen time from their phone's settings.
Measured for 6 months
Smartphone Use - Notifications
Time Frame: Measured for 6 months
Participants in the digital condition will provide the total number of notifications they received, found in their phone's settings.
Measured for 6 months
Smartphone Use - Pickups
Time Frame: Measured for 6 months
Participants in the digital condition will provide the total number of pickups/unlocks of their phone, found in their phone's settings.
Measured for 6 months
Smartphone Use - Apps
Time Frame: Measured for 6 months
Participants in the digital condition will provide their most used apps, found in their phone's settings.
Measured for 6 months
Smartphone Use - Google Calendar
Time Frame: Measured for 6 months
Participants in the digital condition will provide the total amount of time they spent using Google Calendar, found in their phone's settings.
Measured for 6 months
Prospective and Retrospective Memory Questionnaire - Subjective Memory Functioning
Time Frame: Measured for 6 months
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 for 6 months
Modified Functional Activities Questionnaire
Time Frame: Measured for 6 months
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 for 6 months
Neuro-QoL - Depression
Time Frame: Measured for 6 months
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 for 6 months
Insomnia Severity Index
Time Frame: Measured for 6 months
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 for 6 months
Everyday Cognition
Time Frame: Measured for 6 months
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 for 6 months
Coping Self-Efficacy
Time Frame: Measured for 6 months
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 for 6 months
Follow-Up Qualitative Interview
Time Frame: Measured at 6 months
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 at 6 months
Training/Booster Duration
Time Frame: Measured for 1 month (throughout intervention period)
Number of minutes to complete smartphone/memory notebook training
Measured for 1 month (throughout intervention period)
Self Reported Memory Strategy Use
Time Frame: Measured for 6 months
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 for 6 months
Self Reported Current Treatments
Time Frame: Measured for 6 months
Self report usage of pharmacological, cognitive, and group therapies.
Measured for 6 months
Montreal Cognitive Assessment
Time Frame: Measured during screening and at 6 months
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 during screening and at 6 months
General Life Satisfaction
Time Frame: Measured for 6 months
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 for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)
Baylor Scott and White Health
University of Texas at Austin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Scullin, PhD, Baylor University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00004527
  • 1R01AG082783-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will use the repository provided by the Global Alzheimer's Association Interactive Network (GAAIN), depositing data within 9 months of publication.

IPD Sharing Time Frame

Deposit data within 9 months of publication.

IPD Sharing Access Criteria

Open sharing.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings