TabCAT Assessment for Dementia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Disqualifiers: Under 18
No Placebo Group
Approved in 9 Jurisdictions
Trial Summary
What is the purpose of this trial?Efficient and user-friendly paradigms to detect cognitive impairment, including dementia are needed in primary care. The TabCAT Brain Health Assessment accurately detects cognitive impairment via an appealing tablet interface with automated scoring and EMR integration. This study will evaluate the effectiveness of the paradigm on detection rates and other brain health outcomes via a pragmatic cluster randomized trial in 26 Kaiser Southern California primary care clinics.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the TabCAT Brain Health Assessment treatment for dementia?
Research shows that tablet-based cognitive tests, like the TabCAT Brain Health Assessment, are effective in identifying early cognitive impairment in older adults, including those with mild cognitive impairment and Alzheimer's disease. These tests are quick to administer and have been shown to correlate well with traditional cognitive assessments, making them a valid tool for evaluating cognition.
12345Is the TabCAT Assessment for Dementia safe for humans?
The available research does not provide specific safety data for the TabCAT Assessment for Dementia, but it suggests that using mobile devices for cognitive assessments is generally considered feasible and viable, with concerns mainly about privacy and test validation rather than safety.
26789How is the TabCAT Brain Health Assessment treatment different from other treatments for dementia?
The TabCAT Brain Health Assessment is unique because it uses a tablet-based approach to evaluate cognitive functions like memory and attention, making it a quick and accessible tool for identifying early cognitive impairment in older adults.
34101112Eligibility Criteria
This trial is for adults who have visited one of the 26 participating primary care clinics in Southern California during the study period. It's focused on those aged 65 and older for the main analysis but includes adults over 18. Children under 18 cannot participate.Inclusion Criteria
I am 18 years old or older.
Patient with at least one encounter at an intervention clinic during the intervention period
Exclusion Criteria
I am under 18 years old.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Startup
Research team partners with physician leads to adapt the paradigm workflows and onboard PCPs
6 months
Steady State
Effectiveness on primary and secondary outcomes measured; TabCAT-BHA assessments conducted
12 months
Follow-up
Participants are monitored for cognitive assessment and referrals post-intervention
4 months
Participant Groups
The TabCAT Brain Health Assessment, a tablet-based tool designed to detect cognitive impairments including dementia, is being tested. The study aims to see if this user-friendly technology with automatic scoring improves detection rates in a real-world clinic setting.
2Treatment groups
Experimental Treatment
Active Control
Group I: TabCAT-Brain Health Assessment Clinical PathwayExperimental Treatment1 Intervention
Primary care providers concerned that their patients are exhibiting signs of cognitive decline based on patient, informant (family), or provider concerns will refer them for a TabCAT-BHA assessment and follow-up care.
Group II: Usual Care Clinical PathwayActive Control1 Intervention
Patients in the control practices will continue with usual care workflows.
TabCAT Brain Health Assessment is already approved in United States, Brazil for the following indications:
🇺🇸 Approved in United States as TabCAT-BHA for:
- Detection of mild cognitive impairment
- Detection of dementia
🇧🇷 Approved in Brazil as TabCAT-BHA for:
- Detection of mild cognitive impairment
- Detection of dementia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kaiser Permanente Southern California Department of Research & EvaluationPasadena, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
Kaiser PermanenteCollaborator
References
Human Factors and Requirements of People with Cognitive Impairment, Their Caregivers, and Healthcare Professionals for mHealth Apps Including Reminders, Games, and Geolocation Tracking: A Survey-Questionnaire Study. [2022]Mobile Health (mHealth) apps can delay the cognitive decline of people with dementia (PwD), by providing both objective assessment and cognitive enhancement.
Developing dementia prevention trials: baseline report of the Home-Based Assessment study. [2021]This report describes the baseline experience of the multicenter, Home-Based Assessment study, designed to develop methods for dementia prevention trials using novel technologies for test administration and data collection. Nondemented individuals of 75 years of age or more were recruited and evaluated in-person using established clinical trial outcomes of cognition and function, and randomized to one of 3 assessment methodologies: (1) mail-in questionnaire/live telephone interviews [mail-in/phone (MIP)]; (2) automated telephone with interactive voice recognition; and (3) internet-based computer Kiosk. Brief versions of cognitive and noncognitive outcomes were adapted to each methodology and administered at baseline and repeatedly over a 4-year period. "Efficiency" measures assessed the time from screening to baseline, and staff time required for each methodology. A total of 713 individuals signed consent and were screened; 640 met eligibility and were randomized to one of 3 assessment arms; and 581 completed baseline. Dropout, time from screening to baseline, and total staff time were highest among those assigned to internet-based computer Kiosk. However, efficiency measures were driven by nonrecurring start-up activities suggesting that differences may be mitigated over a long trial. Performance among Home-Based Assessment instruments collected through different technologies will be compared with established outcomes over this 4-year study.
Validity of a Novel Touch Screen Tablet-Based Assessment for Mild Cognitive Impairment and Probable AD in Older Adults. [2020]This study aimed to develop a psychometrically valid touch screen tablet-based cognitive test battery to identify early cognitive impairment due to dementia in older adults. The battery includes eight tests with 13 subscores, evaluating visual attention, auditory attention, information processing speed, visual memory, motor control, and visuospatial perception. Among the participants, 43 had been diagnosed with mild cognitive impairment (MCI) and 36 with probable Alzheimer's disease (AD); 41 had no cognitive impairment. The average time to administer the tablet-based tests was 10 minutes. Significant correlations with the Mini-Mental State Examination were found in 9 out of 13 subscores. Patients with probable AD scored significantly lower than controls in 8 out of 13 subscores, whereas those with MCI scored significantly lower in 4 out of 13 subscores. Confirmatory factor analysis using Promax rotation showed that four factors caused lower subscores in the MCI group compared with the controls: information processing speed, memory, visuospatial perception, and motor control. All four factors significantly discriminated the controls from the MCI and probable AD groups, and in the expected direction. The touch screen tablet-based cognitive test battery is psychometrically valid for evaluating cognition in older adults.
Alzheimer's dementia: performance on parallel forms of the dementia assessment battery. [2013]Fifty-four patients with Alzheimer's disease performed on the Dementia Assessment Battery that comprised of finger tapping, forward digit span, naming, verbal memory, visual memory, Token Test, digit cancellation, word-list generation, symbol-digit substitution, and copying geometric designs. Four forms of the battery were administered at weekly intervals. The equivalence of the forms, the relative difficulty of the tests, retest reliability, and factorial composition of the battery are presented. Performance improved with repetition. Impairments in visuo-spatial and verbal abilities were independent of each other. The fragility of the patients' working memory was identified as a main cause for their poor recall. The importance of "component analysis" in individual assessment is illustrated.
Unsupervised mobile app-based cognitive testing in a population-based study of older adults born 1944. [2022]Mobile app-based tools have the potential to yield rapid, cost-effective, and sensitive measures for detecting dementia-related cognitive impairment in clinical and research settings. At the same time, there is a substantial need to validate these tools in real-life settings. The primary aim of this study was thus to evaluate the feasibility, validity, and reliability of mobile app-based tasks for assessing cognitive function in a population-based sample of older adults.
An update on mobile applications collecting data among subjects with or at risk of Alzheimer's disease. [2023]Smart mobile phone use is increasing worldwide, as is the ability of mobile devices to monitor daily routines, behaviors, and even cognitive changes. There is a growing opportunity for users to share the data collected with their medical providers which may serve as an accessible cognitive impairment screening tool. Data logged or tracked in an app and analyzed with machine learning (ML) could identify subtle cognitive changes and lead to more timely diagnoses on an individual and population level. This review comments on existing evidence of mobile device applications designed to passively and/or actively collect data on cognition relevant for early detection and diagnosis of Alzheimer's disease (AD). The PubMed database was searched to identify existing literature on apps related to dementia and cognitive health data collection. The initial search deadline was December 1, 2022. Additional literature published in 2023 was accounted for with a follow-up search prior to publication. Criteria for inclusion was limited to articles in English which referenced data collection via mobile app from adults 50+ concerned, at risk of, or diagnosed with AD dementia. We identified relevant literature (n = 25) which fit our criteria. Many publications were excluded because they focused on apps which fail to collect data and simply provide users with cognitive health information. We found that although data collecting cognition-related apps have existed for years, the use of these apps as screening tools remains underdeveloped; however, it may serve as proof of concept and feasibility as there is much supporting evidence on their predictive utility. Concerns about the validity of mobile apps for cognitive screening and privacy issues remain prevalent. Mobile applications and use of ML is widely considered a financially and socially viable method of compiling symptomatic data but currently this large potential dataset, screening tool, and research resource is still largely untapped.
The Feasibility of At-Home iPad Cognitive Testing For Use in Clinical Trials. [2022]Technological advances now make it feasible to administer cognitive assessments at-home on mobile and touch-screen devices such as an iPad or tablet computer. Validation of these techniques is necessary to assess their utility in clinical trials.
Towards Symptom-Specific Intervention Recommendation Systems. [2022]Mobile devices and their capabilities (e.g., device sensors and human-device interactions) are increasingly being considered for use in clinical assessments and disease monitoring due to their ability to provide objective, repeatable, and more accurate measures of neurocognitive performance. These mobile-based assessments also provide a foundation for the design of intervention recommendations.
Early Detection of Mild Cognitive Impairment (MCI) in an At-Home Setting. [2022]Emerging digital tools have the potential to enable a new generation of qualitative and quantitative assessment of cognitive performance. Moreover, the ubiquity of consumer electronics, such as smartphones and tablets, can be harnessed to support large-scale self-assessed cognitive screening with benefit to healthcare systems and consumers. A wide variety of apps, wearables, and new digital technologies are either available or in development for the detection of mild cognitive impairment (MCI), a risk factor for dementia. Two categories of novel methodologies may be considered: passive technologies (which monitor a user's behavior without active user input) and interactive assessments (which require active user input). Such examinations can be self-administered, supervised by a caregiver, or conducted by an informant at home or outside of a clinical setting. These direct-to-consumer tools have the potential to sidestep barriers associated with cognitive evaluation in primary care, thus improving access to cognitive assessments. Although direct-to-consumer cognitive assessment is associated with its own barriers, including test validation, user experience, and technological concerns, it is conceivable that these issues can be addressed so that a large-scale, self-assessed cognitive evaluation that would represent an initial cognitive screen may be feasible in the future.
Utility of the iPad NIH Toolbox Cognition Battery in a clinical trial of older adults. [2022]To demonstrate feasibility and utility of the iPad version of the NIH Toolbox Cognition Battery (NIHTB-CB) in a clinical trial of older adults.
Development and evaluation of a computerized test battery for Alzheimer's disease screening in community-based settings. [2019]To evaluate the capability of a computerized test battery for Alzheimer's disease screening which has been newly developed to provide a standardized and efficient method for widespread use in routine clinical and community-based settings.
Validation of a new mass screening tool for cognitive impairment: Cognitive Assessment for Dementia, iPad version. [2022]We have developed a new screening test for dementia that runs on an iPad and can be used for mass screening, known as the Cognitive Assessment for Dementia, iPad version (CADi). The CADi consists of items involving immediate recognition memory for three words, semantic memory, categorization of six objects, subtraction, backward repetition of digits, cube rotation, pyramid rotation, trail making A, trail making B, and delayed recognition memory for three words. The present study examined the reliability and validity of the CADi.