Project 2

Cleveland Clinic Foundation, Cleveland OH

Investigators

Linked publications & trials

Abstract

SUMMARY/ABSTRACT PROJECT R-2 Characterization of Patient-Centered Outcomes (Dr. John) Individuals with comorbidities such as high blood pressure and diabetes, among others, are at greater risk of developing Alzheimer’s disease and other neurodegenerative disorders (NDD). Improving the identification and measurement of NDD within patient populations is therefore a public health priority. Neurodegenerative disorders manifest differently among high-risk with disease comorbidities, lifestyle factors, and other exposures. However, accurate measurement of disease and its risk factors is necessary when investigating treatment efficacy. Use of patient-centered outcomes can increase the likelihood of high-risk patient remaining engaged in research. Patient-centered outcomes also increase treatment adherence and improve quality of life. Research in NDD has been slow to embrace and prioritize patient-reported outcome measures. Instead, studies of NDD rely on clinical outcome measures of cognition, behavioral symptoms, and independent functioning, which may be reported only by a caregiver and interpreted by a healthcare provider. Patient and caregiver perceptions of current NDD outcome measures are not well researched, and this is particularly true for individuals with disease comorbidities. Even among common clinical outcome measures, minimal research exists examining the validity and efficacy of these outcomes. The proposed project will utilize an exploratory sequential mixed-methods design to evaluate common clinical trial outcome measures and patient-centered outcomes in NDD in high-risk participants. We will first evaluate the measurement properties of existing clinical trial outcome measures to ensure that they do not affect higher-risk individuals disproportionately. This will allow us to assess the comparability of existing measures across low-risk groups. We will then conduct focus groups with high-risk patients and community-based older adults to identify sensitive healthcare concerns and prioritized patient-centered outcomes. Finally, we will evaluate these perceptions and preferences in greater detail through a survey administered to a larger sample of high-risk community participants and current CNTN patients. The findings from these analyses may have a profound impact on the design and conduct of clinical trials of older adults with NDD, including their outcome measurements. The study goals outlined above will generate pilot data for future research and will help support the project leader in her application for independent research funding.