BackgroundWith the rapid aging of the global population, experts anticipate a surge in the prevalence of mild cognitive impairment (MCI) and dementia worldwide. It is argued that developing more sensitive, easy to administer, and valid MCI screening tools for use in primary care settings may initiate timely clinical and personal care planning and treatment, enabling early access to programs and services. Including functional competence measures in screening tests makes them more ecologically valid and may help to identify cognitive deficits at an earlier stage.ObjectiveWe aim to conduct a preliminary evaluative study comparing the sensitivity, specificity, and reliability of the BrainFx Screen (referred to as SCREEN hereafter), a novel digital tool designed to assess functional competence and detect early signs of cognitive impairment, with the Quick Mild Cognitive Impairment, a validated and highly sensitive tool that detects MCI in the older adult population. We will also investigate the perceived usefulness and integration of the SCREEN into primary care practice to identify demonstrable impacts on clinical workflow and health care providers’ (HCP) perceptions of its success as a screening tool. Patients’ perceptions of completing the SCREEN and its impact on their quality of life will also be explored.MethodsThis study has a concurrent, mixed methods, prospective, and quasi-experimental design. Participants will be recruited from 5 primary care family health teams (FHTs; defined by multidisciplinary practice and capitated funding) across southwestern Ontario, Canada. Participants will include HCPs, patients, care partners, and FHT administrative executives. Patients 55 years and older with no history of diagnoses for MCI, dementia, or Alzheimer disease rostered in one of the FHTs participating in the study will be eligible to participate. Their care partners will help triangulate the qualitative data collected from patients. Participating FHTs will identify an occupational therapist from their site to participate in the study; this HCP will both administer the research protocol and participate in semistructured in-depth interviews and questionnaires. Principal component analysis will be conducted on the SCREEN data to understand the test components better. Tests comparing sensitivity, specificity, and test-retest reliability will assess the validity of SCREEN as a screening tool for MCI.ResultsThis paper describes the study protocol and its activities to date. Data collection was halted early because of COVID-19 restrictions on research activity, and data analysis is currently in progress.ConclusionsAt the end of the project, we anticipate having an initial comparative evaluation of the SCREEN as a tool for early detection of MCI in primary care older adult patient populations. Resource constraints on this research study limit our ability to conduct a randomized controlled trial; however, the results will assist developers of the SCREEN in determining whether rigorous controlled testing is warranted.International Registered Report Identifier (IRRID)DERR1-10.2196/25520
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