Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06444841

Paper-Based and Smartphone-Based Memory Supports

Led by Baylor University · Updated on 2024-07-09

200

Participants Needed

3

Research Sites

222 weeks

Total Duration

On this page

Sponsors

B

Baylor University

Lead Sponsor

U

University of Texas at Austin

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Paper-Based and Smartphone-Based Memory Supports

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Demonstrate capacity to consent via structured interview or have availability for surrogate consent.
  • Clinical features consistent with mild cognitive impairment or dementia confirmed by records or clinical interview.
  • Montreal Cognitive Assessment (MoCA) scores between 17-25 (or 12-18 for telephone assessment), adjusted for demographics.
  • Functional status indicating independence in basic self-care activities (Global Deterioration Scale stage 3 or 4).
  • Adequate sensory and motor skills to use a smartphone with accommodations.
  • Availability of a co-participant over age 18 who sees the participant at least once a month.
  • Co-participant consents to participate and sees the participant at least monthly.
Not Eligible

You will not qualify if you...

  • History of serious mental illness such as schizophrenia or bipolar disorder causing cognitive decline.
  • Moderate to severe dementia indicated by clinical documentation, MoCA scores, or Global Deterioration Scale score 5 or higher.
  • Significant language difficulties interfering with screening.
  • Uncorrected hearing, vision loss, or motor dysfunction that affects training.
  • No available study partner.
  • Individuals not conversational in English are excluded.
  • Co-participants who see the participant less than once per month or are not conversational in English are excluded.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

UT Health Austin Comprehensive Memory Center

Austin, Texas, United States, 78712

Actively Recruiting

2

Baylor Scott & White Healthcare

Temple, Texas, United States, 76508

Not Yet Recruiting

3

Baylor University

Waco, Texas, United States, 76798

Actively Recruiting

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Research Team

M

Michael Scullin, PhD

CONTACT

J

Jared Benge, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Paper-Based and Smartphone-Based Memory Supports | DecenTrialz