RecruitingNot ApplicableNCT06444841

Paper-Based and Smartphone-Based Memory Supports

Smartphone-Based Solutions for Prospective Memory in Mild Cognitive Impairment and Dementia


Sponsor

Baylor University

Enrollment

200 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of memory support tools — a paper-based planner and a smartphone-based app — to help people with mild cognitive impairment (MCI) or early dementia manage day-to-day tasks more independently. Participants work with a "co-participant" (a family member or friend) during the study. **You may be eligible if...** - You have been diagnosed with mild cognitive impairment or early dementia - You score between 17–25 on a standard cognitive test (MoCA) - You can manage basic daily activities on your own - You have a family member or friend who sees you at least once a month and is willing to join - You are conversational in English **You may NOT be eligible if...** - Your main diagnosis is a serious mental illness (such as schizophrenia or bipolar disorder) rather than a memory condition - You have moderate or severe dementia - You have significant uncorrected vision, hearing, or motor problems that would interfere with using a phone - You do not have a study partner Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDigital - 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).

BEHAVIORALPaper-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.


Locations(3)

UT Health Austin Comprehensive Memory Center

Austin, Texas, United States

Baylor Scott & White Healthcare

Temple, Texas, United States

Baylor University

Waco, Texas, United States

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NCT06444841


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