Paper-Based and Smartphone-Based Memory Supports

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	50 Years and Over
Gender	All

More Inclusion & Exclusion 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.

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06444841
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Baylor University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michael Scullin, PhD
Principal Investigator Affiliation	Baylor University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Alzheimer Disease, Dementia, Mild, Mild Cognitive Impairment

Arms & Interventions

Arms

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.

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.

Interventions

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).

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Austin 4671654, Texas 4736286

Status

Recruiting

Address

UT Health Austin Comprehensive Memory Center

Austin 4671654, Texas 4736286, 78712

Site Contact

Jared Benge, PhD

[email protected]

512-495-5285

Baylor Scott & White Healthcare, Temple 4735966, Texas 4736286

Status

Not yet recruiting

Address

Baylor Scott & White Healthcare

Temple 4735966, Texas 4736286, 76508

Site Contact

Michael Scullin

[email protected]

254-710-2251

Baylor University, Waco 4739526, Texas 4736286

Status

Recruiting

Address

Baylor University

Waco 4739526, Texas 4736286, 76798

Site Contact

Michael Scullin

[email protected]

254-710-2251

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