Development and Validation of an Instrument to Assess Cognitive Function Regulati

DESCRIPTION (provided by applicant): Cognitive impairment is a serious public issue affecting more than one-third of Americans aged 71 and older. Impaired cognitive function compromises dentally-related function (DRF) (e.g, making treatment decisions, performing oral hygiene care, and following homecare instructions), remarkably increasing risk of dental caries, periodontal disease and other oral health issues. Poor oral health is associated with diabetes and increases risk of cardiovascular disease and recurrent respiratory infection, the leading causes of death in special-needs patients. Currently, due to the lack of a reliable and practical methodology, DRF assessment is not a standard part of dental assessment and treatment planning. This fact likely affects quality of care and increases the risk of avoidable complications. In response to this unmet need, Dr. Xi Chen (PI) proposes a career development plan to develop an instrument to assess DRF in cognitively-impaired patients. Dr. Chen is one of the few fellowship-trained geriatric dentists with a substantial grounding in research. He completed his geriatric dentistry fellowship and PhD training in Health Informatics at the University of Minnesota and started his career as an assistant professor at the University of North Carolina at Chapel Hill (UNC-CH) in 2008. His unique background in geriatric dentistry, gerontology and clinical research, together with a strong passion and sense of professional responsibility to advance the field of geriatric dentistry, make him an outstanding candidate for this award. In the past three years, UNC-CH has provided start-up funds, protected time and other excellent support for Dr. Chen, which enabled him to formulate a multidisciplinary mentoring team and complete a number of preliminary studies to conceptualize and test the hypotheses of the proposed studies. A prototype instrument has also been developed and is now ready for further testing. All of these elements have prepared Dr. Chen to become an independent investigator in geriatric dental research. The proposed career development plan includes supervised study and mentored research that will augment Dr. Chen's previous training, complement his proposed research, and develop the expertise needed to foster his transition to being an independent geriatric dental researcher. The proposed training plan consists of didactics (e.g. cognitive neuroscience, cognitive function assessment and measurement design, epidemiology and statistics), clinical and research seminars, and supervised clinical rotation in the UNC neurology clinic. During this award Dr. Chen will meet with his mentors once every other week to discuss the proposed research, training and other career development issues. These training activities aim to help Dr. Chen: A) develop expertise in cognitive and functional assessment for cognitively-impaired patients; B) develop expertise in health measurement scale development and validation; and C) improve clinical research skills. Complementary to the training plan, the mentored research plan aims to enhance Dr. Chen's clinical study skills and provide experience in patient-oriented dental research, all of which is essential to achieving his long- term goal -- development of a new evidence-based dental care model for dementia patients. The proposed research plan is an essential step toward his long-term goal and can be divided into two phases. Phase I is to refine the proposed Dentally-related Function Test (DRF-Test) (Specific Aim 1). A prototype DRF-Test including 17 items has been developed by the PI through literature review and focus group discussions. Two content validity tests, one with practicing geriatric dental experts and one with geriatric experts on cognitive/functional assessment, and a field testing will be conducted. These results will be used to further refine the prototype instrument. The psychometric properties of the DRF-Test will be evaluated during Phase II (Specific Aim 2). The DRF-Test and standard cognitive/functional assessments will be administered to 200 participants with MCI or dementia. Factor analysis will be performed to examine the structure of the DRF-Test and eliminate redundant or poorly-performed items. The reliability and validity of the DRF-Test will be evaluated using the Classical Test Theory. As a part of the validation studies, a subset of the study sample (N=125) will be randomly selected to receive oral health assessment focusing on oral hygiene status, denture hygiene (if applicable), gum inflammation and dental caries prevalence. The association between oral health measures and DRF in cognitively-impaired patients will be examined to provide data required to develop evidence-based interventions for cognitively-impaired patients in a future study. The proposed study and training plans are expected to provide Dr. Chen with the skills and experience essential to developing as a patient oriented researcher in geriatric dentistry. This proposal will also result in a practical method to measure DRF, leading to methods for incorporating these results into clinical assessment and treatment planning. Based on the results of this study, a future evidence-based, individualized oral health intervention protocol corresponding to patients' oral health needs, DRF and level of caregiver support will be developed and tested in patients with MCI or dementia. After that, a randomized control study will be conducted to evaluate how DRF-test and this evidence-based protocol may inform clinician's decision and improve clinical practice for cognitively-impaired patients. All of these are essential to achieving my long-term goal of developing a new evidence-based model of dementia dental care.