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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UT Health Austin Comprehensive Memory Center
  Austin, Texas, United States Recruiting
• Baylor University
  Waco, Texas, United States Recruiting
• Baylor Scott & White Healthcare
  Temple, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Michael Scullin, PhD — Baylor University
• Study coordinator: Michael Scullin, PhD
• Email: michael_scullin@baylor.edu
• Phone: 254-710-2251

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.