Paper-Based and Smartphone-Based Memory Supports

NCT ID: NCT06444841

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-27
• Study Completion Date: 2028-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital - Google Calendar

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Paper-based - Memory Support System

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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.

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: collaborator

Baylor Scott and White Health

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Baylor University

OTHER

Sponsor Role: lead

Responsible Party

Michael Scullin

Associate Professor of Psychology and Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Scullin, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Locations

UT Health Austin Comprehensive Memory Center

Austin, Texas, United States

Site Status: RECRUITING

Baylor Scott & White Healthcare

Temple, Texas, United States

Site Status: NOT_YET_RECRUITING

Baylor University

Waco, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Scullin, PhD

Role: CONTACT

michael_scullin@baylor.edu

254-710-2251

Jared Benge, PhD

Role: CONTACT

jared.benge@austin.utexas.edu

512-495-5285

Facility Contacts

Jared Benge, PhD

Role: primary

jared.benge@austin.utexas.edu

512-495-5285

Michael Scullin

Role: primary

Michael Scullin

Role: primary

Other Identifiers

1R01AG082783-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004527

Identifier Type: -

Identifier Source: org_study_id