Using paper and smartphone aids to help memory in Alzheimer's and dementia patients

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

This study is testing whether using paper or smartphone memory aids can help people with mild cognitive impairment and mild dementia remember things better in their daily lives.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Baylor University (Academic / other)
• Locations: 3 sites (Austin, Texas and 2 other locations)
• Trial ID: NCT06444841 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of paper-based and smartphone-based memory aids in improving prospective memory among individuals with mild cognitive impairment and mild dementia. The study will recruit 200 participants who will be randomly assigned to use either digital tools like Google Calendar or a paper-based memory support system. The trial will assess the efficacy, durability, and generalizability of these memory aids in enhancing daily functioning and quality of life for participants. The approach builds on previous pilot studies that indicated the potential of smartphone applications to assist with memory tasks.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with mild cognitive impairment or mild dementia who can provide informed consent.

Not a fit: Patients with severe cognitive impairment or those unable to engage with either paper or digital memory aids may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly enhance the ability of patients with mild cognitive impairment and dementia to manage their daily activities and improve their quality of life.

How similar studies have performed: Previous studies have shown promise in using smartphone-based memory aids for similar populations, indicating a potential for success in this approach.

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.

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.

Where this trial is running

Austin, Texas and 2 other locations

• UT Health Austin Comprehensive Memory Center — Austin, Texas, United States (Recruiting)
• Baylor Scott & White Healthcare — Temple, Texas, United States (Not_yet_recruiting)
• Baylor University — Waco, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Michael Scullin, PhD — Baylor University
• Study coordinator: Michael Scullin, PhD

Conditions Alzheimer Disease; Dementia, Mild; Mild Cognitive Impairment