Paper-Based and Smartphone-Based Memory Supports

NCT06444841 | Recruiting DMC

• 2 other identifiers: STUDY000045271R01AG082783-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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 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 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 for 6 months

Secondary Outcomes (19)

• Caregiving Cognitive Burden

  Measured for 6 months

• Calendar Use

  Measured for 6 months

• Montreal Cognitive Assessment

  Measured during screening and at 6 months

• Smartphone Use - Screen Time

  Measured for 6 months

• Smartphone Use - Notifications

  Measured for 6 months

Study Arms (2)

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.

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.

Behavioral: Paper-based - Memory Support System

Interventions

Digital - Google Calendar BEHAVIORAL

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).

Smartphone-based app

Paper-based - Memory Support System BEHAVIORAL

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.

Paper-based notebook

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• The co-participant will need to be over the age of 18, consent to participation, and see the participant at least once per month.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Baylor University: lead
• University of Texas at Austin: collaborator
• Baylor Scott and White Health: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

UT Health Austin Comprehensive Memory Center

Austin, Texas, 78712, United States

RECRUITING

Baylor Scott & White Healthcare

Temple, Texas, 76508, United States

NOT YET RECRUITING

Baylor University

Waco, Texas, 76798, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Lymphoma, Follicular; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cognition Disorders

Study Officials

• Michael Scullin, PhD

  Baylor University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Scullin, PhD

CONTACT

254-710-2251; michael_scullin@baylor.edu

Jared Benge, PhD

CONTACT

512-495-5285; jared.benge@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology and Neuroscience

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 6, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deposit data within 9 months of publication.
• Access Criteria: Open sharing.

Locations

US (3)