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Study of Paper-Based and Smartphone-Based Memory Supports for Alzheimer's and Dementia

This study is looking at how well different memory aids work for people with mild cognitive impairment (MCI) or mild dementia, including Alzheimer's disease. Researchers are testing two types of support: a paper-based Memory Support System and digital Google Calendar apps. These tools help people remember future tasks, like taking medicine. The study aims to see if these aids can improve your ability to remember things, how you feel about your memory, and the quality of life for caregivers. You may be able to join if you are 50 or older and have MCI or dementia. The study plans to enroll 200 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 200 participants. It is testing two different behavioral interventions: a paper-based system and a digital calendar app.
What's involved
The study will measure your objective and patient-selected prospective memory performance, and caregiver quality of life, for 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months to assess primary endpoints.

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NCT06444841

Paper-Based and Smartphone-Based Memory Supports

Recruiting
NAAges 50+InterventionalSupportive care
Baylor University
~200 participants
Updated 2024-07-09 on ClinicalTrials.gov
What's tested:Digital - Google CalendarPaper-based - Memory Support System

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Prospective Memory Performance
Measured over Measured for 6 months
+2 more outcomes measured

Conditions

Alzheimer Disease
Dementia, Mild
Mild Cognitive Impairment

Explore related trials

Alzheimer's DiseaseDementiaMild cognitive disorder

Where it's being run

3 sites across 1 states
Texas3

Study leadership

  • Michael Scullin, PhD · PRINCIPAL_INVESTIGATOR · Baylor University

Who to contact

Michael Scullin, PhD
[email protected]
254-710-2251
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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.
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.

What this trial measures

  • Objective Prospective Memory PerformanceMeasured for 6 months

    Participants will need to remember to call the study phone number at both 1) regular times each week (set at baseline for the entire study duration), and 2) irregular times each week (experimenter-assigned times that change).

  • Patient-Centered/Patient-Selected Prospective Memory PerformanceMeasured for 6 months

    Based on the goal attainment scaling framework; via a structured interview at baseline, the participant and study partner will identify 5-10 activities from the participant's daily routine that require frequent use of prospective memory. At follow-up sessions, participants rate the degree to which each of these personal activities improved or worsened.

  • Caregiving-Related Quality of LifeMeasured for 6 months

    Co-participants will complete the Direct Impact of Care (Scales Measuring the Impact of Dementia on Carers - Direct Impact) scale. This scale has 18 items to which the co-participant respond Agree or Disagree, with Agree responses indicating a greater impact of the care they provide on their own lives.