Rationale, Design, and Baseline Characteristics of the VALIANT (COVID-19 in Older Adults: A Longitudinal Assessment) Cohort

Background Most older adults hospitalized with COVID-19 survive their acute illness. The impact of COVID-19 hospitalization on patient-centered outcomes, such as physical function, cognitive function, and symptoms, is not well understood. We sought to address this knowledge gap by collecting longitudinal data about these issues from a cohort of older adult survivors of COVID-19 hospitalization. Methods We undertook a prospective study of community-living persons age ≥60 years who were hospitalized with COVID-19 from June 2020 to June 2021. A baseline interview was conducted during or up to two weeks after hospitalization. Follow-up interviews occurred at one, three, and six months post-discharge. In interviews, participants completed comprehensive assessments of physical and cognitive function, symptoms, and psychosocial factors. If a participant was too impaired to complete an interview, an abbreviated assessment was performed with a proxy. Additional information was collected from the electronic health record. Baseline characteristics of the cohort are reported here. Results Among 341 participants, the mean age was 71.4 (SD 8.4) years, 51% were women, and 37% were of Black race or Hispanic ethnicity. Median length of hospitalization was 8 (IQR 6-12) days. All but 4% of participants required supplemental oxygen and 21% required a higher level of care in an intensive care unit or stepdown unit. Nearly half (47%) reported at least one disability in physical function, 45% demonstrated cognitive impairment, and 67% were pre-frail or frail. Participants reported a mean of 9 of 14 (SD 3) COVID-19-related symptoms. Conclusions Older adults hospitalized with COVID-19 demonstrated high rates of baseline physical and cognitive impairment as well as high symptom burden. Longitudinal findings from this cohort will advance our understanding of outcome trajectories of great importance to older survivors of COVID-19. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was supported by the Claude D. Pepper Older Americans Independence Center at Yale University (P30AG21342 and P30AG21342-18S1). Dr. Cohen and Dr. Ferrante were supported by Paul B. Beeson Emerging Leaders in Aging awards (K76AG059987 and K76AG057023) from the National Institute on Aging. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Institutional Review Board of Yale School of Medicine gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data from VALIANT will be made available to the public, for use upon approval by the principal investigators, at one year from completion of data collection (January 31, 2023).