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Introduction: Annual cognitive screening in older adults is essential for early detection of cognitive impairment, yet primary care settings face time constraints that present barriers to routine screening. A remote cognitive screener completed on a patient's personal smartphone before a visit has the potential to save primary care clinics time, encourage broader screening practices and increase early detection of cognitive decline. MyCog Mobile is a promising new remote smartphone-based cognitive screening app for primary care settings. We propose a combined construct and clinical validation study of MyCog Mobile., Methods and Analysis: We will recruit a total sample of 300 adult participants aged 65 years and older. A subsample of 200 healthy adult participants and a subsample of 100 adults with a cognitive impairment diagnosis (ie, dementia, mild cognitive impairment, cognitive deficits or other memory loss) will be recruited from the general population and specialty memory care centres, respectively. To evaluate the construct validity of MyCog Mobile, the healthy control sample will self-administer MyCog Mobile on study-provided smartphones and be administered a battery of gold-standard neuropsychological assessments. We will compare correlations between performance on MyCog Mobile and measures of similar and dissimilar constructs to evaluate convergent and discriminant validity. To assess clinical validity, participants in the clinical sample will self-administer MyCog Mobile on a smartphone and be administered a Mini-Cog screener and these data will be combined with the healthy control sample. We will then apply several supervised model types to determine the best predictors of cognitive impairment within the sample. Area under the receiver operating characteristic curve, accuracy, sensitivity and specificity will be the primary performance metrics for clinical validity., Ethics and Dissemination: The Institutional Review Board at Northwestern University (STU00214921) approved this study protocol. Results will be published in peer-reviewed journals and summaries provided to the study's funders., Competing Interests: Competing interests: MW reports grants from the NIH, Gordon and Betty Moore Foundation, and Eli Lilly and personal fees from Pfizer, Sanofi, Luto UK, University of Westminster, Lundbeck and GlaxoSmithKline outside the submitted work. All other authors report no conflicts of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To help promote early detection of cognitive impairment in primary care, MyCog Mobile was designed as a cognitive screener that can be self-administered remotely on a personal smartphone. We explore the potential utility of MyCog Mobile in primary care by comparing MyCog Mobile to a commonly used screener, Mini-Cog., Methods: A sample of 200 older adults 65+ years (mean age = 72.56 years), completed the Mini-Cog and MyCog Mobile, which includes 2 memory measures and 2 executive functioning measures. A logistic regression model was conducted to predict failing Mini-Cog scores (≤2) based on MyCog Mobile measures., Results: A total of 20 participants earned a Mini-Cog score ≤2. MyCog Mobile demonstrated an AUC of 0.83 (95% bootstrap CI [0.75, 0.95]), sensitivity of 0.76 (95% bootstrap CI [0.63, 0.97]), and specificity of .88 (95% bootstrap CI [0.63, 0.10]). The subtest Name Matching from MyFaces and MySorting were the only significant predictors of failed Mini-Cogs., Conclusions: MyCog Mobile demonstrated sensitivity and specificity to identify participants who failed the Mini-Cog, and may show promise as a screening tool for cognitive impairment in older adults. Further research is necessary to establish the clinical utility of MyCog Mobile in a larger sample using documented clinical diagnoses., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: Many older adults receive assistance in managing their chronic conditions. Yet complicating the utility of caregiver support is whether caregivers have sufficient skills to aid in older adults' health management at home. We examined associations between caregiver health literacy and performance on health tasks., Methods: Caregivers to older adults enrolled in a cognitive aging cohort were recruited to participate in a supplemental interview ( n  = 97). Caregivers completed one structured interview that included assessments of health literacy and health task performance., Results: Caregivers demonstrated a range of health literacy skills (44% adequate, 36% marginal, 20% low health literacy). In adjusted analyses, caregivers with marginal and low health literacy demonstrated worse overall performance on the health tasks, and poorer interpretation of health information presented on print documents and recall of spoken communication (p's < 0.05)., Conclusion: Caregivers with marginal or low health literacy demonstrated poorer performance on everyday health tasks that they commonly assist older adults with. The application of health literacy best-practices to support better training and capacity-building for caregivers is warranted., Innovation: Few studies have considered the health literacy skills of caregivers and its application to caregivers' abilities to carry out common supportive tasks., Competing Interests: Dr. O'Conor reports grants from the NIH outside of the submitted work. Dr. Wolf reports grants from the NIH, Gordon and Betty Moore Foundation, and Eli Lilly, and personal fees from Pfizer, Sanofi, Luto UK, University of Westminster, Lundbeck and GlaxoSmithKline outside the submitted work. All other authors report no conflicts of interest., (© 2023 The Authors. Published by Elsevier B.V.)

Introduction: COVID-19 is an unprecedented public health threat in modern times, especially for older adults or those with chronic illness. Beyond the threat of infection, the pandemic may also have longer-term impacts on mental and physical health. The COVID-19 & Chronic Conditions ('C3') study offers a unique opportunity to assess psychosocial and health/healthcare trajectories over 5 years among a diverse cohort of adults with comorbidities well-characterised from before the pandemic, at its onset, through multiple surges, vaccine rollouts and through the gradual easing of restrictions as society slowly returns to 'normal'., Methods and Analysis: The C3 study is an extension of an ongoing longitudinal cohort study of 'high-risk' adults (aged 23-88 at baseline) with one or more chronic medical conditions during the COVID-19 pandemic. Five active studies with uniform data collection prior to COVID-19 were leveraged to establish the C3 cohort; 673 adults in Chicago were interviewed during the first week of the outbreak. The C3 cohort has since expanded to include 1044 participants across eight survey waves (T 1 -T 8 ). Four additional survey waves (T 9 -T 12 ) will be conducted via telephone interviews spaced 1 year apart and supplemented by electronic health record and pharmacy fill data, for a total of 5 years of data post pandemic onset. Measurement will include COVID-19-related attitudes/behaviours, mental health, social behaviour, lifestyle/health behaviours, healthcare use, chronic disease self-management and health outcomes. Mental health trajectories and associations with health behaviours/outcomes will be examined in a series of latent group and mixed effects modelling, while also examining mediating and moderating factors., Ethics and Dissemination: This study was approved by Northwestern University's Feinberg School of Medicine Institutional Review Board (STU00215360). Results will be published in international peer-reviewed journals and summaries will be provided to the funders of the study., Competing Interests: Competing interests: SCB reports grants from the NIH, Merck, Pfizer, Gordon and Betty Moore Foundation, Retirement Research Foundation for Aging, Lundbeck, Gilead and Eli Lilly via her institution and personal fees from Sanofi, Pfizer, University of Westminster, Lundbeck, Gilead and Luto UK outside the submitted work. MW reports grants from the NIH, Gordon and Betty Moore Foundation, and Eli Lilly, and personal fees from Pfizer, Sanofi, Luto UK, University of Westminster and Lundbeck outside the submitted work. All other authors have no conflicts of interest to disclose., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Many older adults receive assistance in managing chronic conditions. Yet complicating the utility of caregiver support is whether caregivers have sufficient skills to aid in a patient's self-care. Health literacy and cognition are important determinants of older adults' health outcomes, but few studies have examined caregiver health literacy, cognition and self-care skills and their relations to patient outcomes., Methods and Analysis: We will expand an ongoing cognitive ageing cohort study (LitCog) to enroll a parallel caregiver cohort. Caregivers are eligible if they are (1) ≥18 years of age, (2) provided care for ≥6 months and (3) assisted with at least one activity of daily living, instrumental activity of daily living or health management task. Caregivers will complete interviews at time points corresponding with the LitCog participant interviews. Caregivers will complete assessments of health literacy, self-care skills, cognitive function, caregiver healthcare task difficulty, caregiver burden, caregiver self-efficacy, activation, technology use, busyness and routine and relationship quality. Caregivers will self-report the nature and intensity of care provided, and their own health status. Associations between caregiver presence and caregiver capacity with patient outcomes will be examined in a series of regression models, and mediating and moderating factors will be tested., Ethics and Dissemination: The Institutional Review Board at Northwestern University has approved the study protocol (STU00026255). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study as well as patients and caregivers., Competing Interests: Competing interests: MW reports grants from the NIH, Gordon and Betty Moore Foundation and Eli Lilly, and personal fees from Pfizer, Sanofi, Luto UK, University of Westminster, Lundbeck and GlaxoSmithKline outside the submitted work. All other authors report no conflicts of interest., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Early identification of cognitive impairment (CI), including Alzheimer's disease and related dementias (ADRD), is a top public health priority. Yet, CI/ADRD is often undetected and underdiagnosed within primary care settings, and in health disparate populations. The MyCog paradigm is an iPad-based, self-administered, validated cognitive assessment based on the National Institutes of Health (NIH) Toolbox Cognition Battery and coupled with clinician decision-support tools that is specifically tailored for CI/ADRD detection within diverse, primary care settings., Methods and Analysis: We will conduct a two-arm, primary care practice-randomised (N=24 practices; 45 257 active patients at the proposed practices), pragmatic trial among geographically diverse Oak Street Health sites to test the effectiveness of the MyCog paradigm to improve early detection CI/ADRD among low socioeconomic, black and Hispanic older adults compared with usual care. Participating practices randomised to the intervention arm will impart the MyCog paradigm as a new standard of care over a 3-year implementation period; as the cognitive component for Annual Wellness Visits and for any patient/informant-reported or healthcare provider-suspected cognitive concern. Rates of detected (cognitive test suggesting impairment) and/or diagnosed (relevant International Classification of Diseases-9/10 [ICD-9/10] code) cognitive deficits, impairments or dementias including ADRD will be our primary outcome of study compared between arms. Secondary outcomes will include ADRD severity (ie, mild or later stage), rates of cognitive-related referrals and rates of family member or caregiver involvement in ADRD care planning. We will use generalised linear mixed models to account for clustered study design. Secondary models will adjust for subject, clinic or visit-specific characteristics. We will use mixed-methods approaches to examine fidelity and cost-effectiveness of the MyCog paradigm., Ethics and Dissemination: The Institutional Review Board at Advarra has approved the study protocol (Pro00064339). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study., Trial Registration Number: NCT05607732., Competing Interests: Competing interests: MW reports grants from the NIH, Gordon and Betty Moore Foundation, and Eli Lilly, and personal fees from Pfizer, Sanofi, Luto UK, University of Westminster, Lundbeck and GlaxoSmithKline outside the submitted work. All other authors report no conflicts of interest., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Liver transplantation is a life-saving option for decompensated cirrhosis. Liver transplant recipients require advanced self-management skills, intact cognitive skills, and care partner support to improve long-term outcomes. Gaps remain in understanding post-liver transplant cognitive and health trajectories, and patient factors such as self-management skills, care partner support, and sleep. Our aims are to (1) assess pre-liver transplant to post-liver transplant cognitive trajectories and identify risk factors for persistent cognitive impairment; (2) evaluate associations between cognitive function and self-management skills, health behaviors, functional health status, and post-transplant outcomes; and (3) investigate potential mediators and moderators of associations between cognitive function and post-liver transplant outcomes. LivCog is a longitudinal, prospective observational study that will enroll 450 adult liver transplant recipients and their caregivers/care partners. The duration of the study is 5 years with 24 additional months of patient follow-up. Data will be collected from participants at 1, 3, 12, and 24 months post-transplant. Limited pre-liver transplant data will also be collected from waitlisted candidates. Data collection methods include interviews, surveys, cognitive assessments, and actigraphy/sleep diary measures. Patient measurements include sociodemographic characteristics, pretransplant health status, cognitive function, physical function, perioperative measures, medical history, transplant history, self-management skills, patient-reported outcomes, health behaviors, and clinical outcomes. Caregiver measures assess sociodemographic variables, health literacy, health care navigation skills, self-efficacy, care partner preparedness, nature and intensity of care, care partner burden, and community participation. By elucidating various health trajectories from pre-liver transplant to 2 years post-liver transplant, LivCog will be able to better characterize recipients at higher risk of cognitive impairment and compromised self-management. Findings will inform interventions targeting health behaviors, self-management, and caregiver supports to optimize outcomes., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Association for the Study of Liver Diseases.)

Background and Aims: Liver transplantation is a life-saving procedure for end-stage liver disease. However, post-transplant medication regimens are complex and non-adherence is common. Post-transplant medication non-adherence is associated with graft rejection, which can have long-term adverse consequences. Transplant centres are equipped with clinical staff that monitor patients post-transplant; however, digital health tools and proactive immunosuppression adherence monitoring has potential to improve outcomes., Methods and Analysis: This is a patient-randomised prospective clinical trial at three transplant centres in the Northeast, Midwest and South to investigate the effects of a remotely administered adherence programme compared with usual care. The programme monitors potential non-adherence largely levering text message prompts and phenotypes the nature of the non-adhere as cognitive, psychological, medical, social or economic. Additional reminders for medications, clinical appointments and routine self-management support are incorporated to promote adherence to the entire medical regimen. The primary study outcome is medication adherence via 24-hour recall; secondary outcomes include additional medication adherence (ASK-12 self-reported scale, regimen knowledge scales, tacrolimus values), quality of life, functional health status and clinical outcomes (eg, days hospitalised). Study implementation, acceptability, feasibility, costs and potential cost-effectiveness will also be evaluated., Ethics and Dissemination: The University of Pennsylvania Review Board has approved the study as the single IRB of record (protocol # 849575, V.1.4). Results will be published in peer-reviewed journals and summaries will be provided to study funders., Trial Registration Number: NCT05260268., Competing Interests: Competing interests: MS reports additional grants from NIH/NIDDK/NIAAA, PCORI, and Grifols, SA., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: At the onset of the pandemic, there was poor public awareness and inaction in response to COVID-19; it is less known whether this translated to subsequent infections., Objectives: To explore whether adults who perceived COVID-19 as less of a threat and who were not taking early actions were more likely to become infected over the following year., Research Design: Survey data from the ongoing (COVID-19 & Chronic Conditions (C3) anonymized for review) cohort study., Participants: Six hundred forty-two adults with a mean age of 63 and ≥1 chronic condition., Measures: Self-reported attitudes and behaviors regarding COVID-19 were assessed from March 13 to April 3, 2020, and COVID-19 infection status was captured between May 2020 and January 2021. Bivariate and multivariable analyses examined associations between early perceptions and behaviors with later infection., Results: Approximately 7% reported infection with COVID-19 (N = 46). Adults who perceived the threat of COVID-19 less seriously at the initial outbreak were more likely to test positive over the following year [odds ratio (OR): 0.81, CI: 0.70-0.94; P = 0.006]. Those who were less likely to believe their actions would affect whether they would become infected were more likely to test positive (OR: 0.87, CI: 0.77-0.99; P = 0.03), as were adults who reported not changing their routines (OR: 0.45; CI: 0.24-0.85; P = 0.01)., Conclusions: Adults with delayed responses in acknowledging the threat of COVID-19 and in changing behaviors were more likely to contract the virus. This investigation provides insight into the consequences of inadequate public understanding and response to COVID-19, and it highlights the importance of promoting early awareness among high-risk groups during public health crises., Competing Interests: M.S.W. reports grants from the NIH during the conduct of the study; grants from Merck, the Gordon and Betty Moore Foundation, the NIH, and Eli Lilly outside the submitted work; and personal fees from Sanofi, Pfizer, GlaxoSmithKline, Lundbeck, Bristol Myers Squibb, and Luto outside the submitted work. S.C.B reports grants from the NIH during the conduct of the study; grants from Merck, Lundbeck, Pfizer, NIH, and Eli Lilly outside the submitted work; grants and personal fees from Pfizer, Sanofi, Lundbeck, the Gordon and Betty Moore Foundation outside the submitted work; and personal fees from Sanofi, Pfizer, and Luto outside the submitted work. The remaining authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Loneliness was common early in the COVID-19 pandemic due to physical distancing measures, but little is known about how loneliness persisted into later stages of the pandemic. We therefore examined longitudinal trajectories of loneliness over 18 months of the pandemic and subgroups at risk for persistent loneliness., Methods: We used data from the COVID-19 & Chronic Conditions study collected between March 27, 2020 to December 10, 2021, including 641 predominantly older adults with ≥1 chronic condition who completed six interviews at approximately 3 month intervals. Participants reported loneliness (defined as some, most, or all of the time) during the past week due to COVID-19. We used trajectory mixture models to identify clusters of individuals following similar trajectories of loneliness, then determined subgroups likely to be classified in different loneliness trajectories using multivariable regression models adjusted for sociodemographic and clinical covariates., Results: Participants were on average 63 years old, 61% female, 30% Black, 20% Latinx, and 29% were living below the poverty level. There was an overall reduction in loneliness over time (March to April/2020: 51% to September to December/2021: 31%, p = 0.01). Four distinct trajectory groups emerged: (1) "Persistent Loneliness" (n = 101, 16%); (2) "Adapted" (n = 141, 22%), individuals who were initially lonely, with feelings of loneliness decreasing over time; (3) "Occasional loneliness" (n = 189, 29%); and (4) "Never lonely" (n = 211, 33%). Subgroups at highest risk of the "Persistently Lonely" trajectory included those identifying as Latinx (aOR 2.5, 95% CI: 1.2, 5.2), or living in poverty (aOR 2.5; 95% CI: 1.4, 4.6)., Conclusions: Although loneliness declined for a majority of older adults during the pandemic in our sample, persistent loneliness attributed to the COVID-19 pandemic was common (1 in 6 adults), particularly among individuals identifying as Hispanic/Latinx or living in poverty. Interventions addressing loneliness can ease pandemic-related suffering, and may mitigate long-term mental and physical health consequences., (© 2022 The American Geriatrics Society.)

In a survey of older adults at higher risk for COVID-19 complications, we sought to describe expectations of trust in the safety and efficacy of a future COVID-19 vaccine, and level of hesitancy about receiving it. We also assessed whether these expectations were associated with known or suspected contributors to vaccine hesitancy, disparities in vaccine receipt, and potential targets for public health outreach. From May 1-22, 2020, we performed telephone surveys of 601 older adults with chronic conditions in metro Chicago about their COVID-19 experiences and levels of vaccine trust and hesitancy. All participants previously completed assessments of demographics, health status, health literacy and activation. Bivariate associations were performed using t-tests or one-way ANOVA, and multivariate analyses using least square means. Younger age (<60), Black race, greater complacency about contracting COVID-19, and lower confidence in state or local government were associated with significantly lower trust in a vaccine's safety and efficacy. Black race and greater complacency about contracting COVID-19 were associated with a significantly greater vaccine hesitancy. Amongst Black participants, vaccine hesitancy varied significantly by confidence in the federal government. Trust and hesitancy regarding a future COVID-19 vaccine were associated with age, race, complacency regarding contracting COVID-19, and confidence in government response to the pandemic, but not education, health literacy or activation. Therefore, efforts to vaccinate higher risk older adults must aim not only to educate and provide vaccine access, but engender trust in the vaccine development process and vaccination strategies at both the federal and the local level., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 Published by Elsevier Inc.)

Background: Health literacy is often viewed as a static trait in longitudinal studies, which may over or underestimate an individual's ability to manage one's health., Objectives: We sought to examine health literacy over time among older adults using three widely used measures., Design: A prospective cohort study., Participants: Community-dwelling adults ages 55 to 74 at baseline with at least one follow-up visit (N = 656) recruited from one academic internal medicine clinic and six community health centers in Chicago, IL., Measures: Health literacy was measured using the Test of Functional Health Literacy in Adults (TOFHLA), Newest Vital Sign (NVS), and Rapid Estimate of Adult Literacy in Medicine (REALM) at baseline and up to three follow-up time points., Results: In unadjusted analyses, significant changes since baseline were found beginning at the second follow-up (mean (M) = 6.0 years, SD = 0.6) for the TOFHLA (M = - 0.9, SD = 0.95, p = 0.049) and the REALM (M = 0.3, SD = 2.5, p = 0.004) and at the last follow-up (M = 8.6 years, SD = 0.5) for the NVS (M = - 0.2, SD = 1.4, p = 0.02). There were non-linear effects of baseline age on TOFHLA and NVS scores over time (piecewise cubic spline p = 0.01 and p < 0.001, respectively) and no effect on REALM scores (B = 0.02, 95% CI - 0.01 to 0.04, p = 0.17) using multivariable mixed-effects linear regression models, controlling for race, education, income, and comorbidity., Conclusion: We found a negative relationship between age and health literacy over time as measured by the TOFHLA and NVS. Health literacy barriers appear to be more prevalent among individuals in later life, when self-care demands are similarly increasing. Clinicians might consider strategies to assess and respond to limited health literacy, particularly among patients 70 and older. REALM performance remained stable over 10 years of follow-up. This questions whether health literacy tools measure the same attribute. Prospective health literacy studies should carefully consider what measures to use, depending on their objective.

Objectives: Physical distancing precautions during the COVID-19 pandemic may challenge the provision of tangible support many middle age and older adults receive in managing their health. We examined the association between unmet tangible support needs and self-management behaviors and mental health status during the stay-at-home orders in Chicago and New York., Methods: We used data from the COVID-19 & Chronic Conditions study collected between May 1st and May 22nd, 2020. A total of 801 middle age and older adults with ≥1 chronic condition in Chicago and New York City completed the telephone interview. Adequacy of tangible social support was measured using a brief, validated scale that determined whether an individual needed assistance managing his or her health, and if yes, whether this need was met. Participants reported their level of difficulty engaging in self-management behaviors using 2 discrete items; they also self-reported medication adherence using the ASK-12 medication adherence scale. Mental health status was measured using the depression and anxiety PROMIS short-form instruments., Results: Participants' mean age was 63 years; 30% identified as Black, 26% identified as Latino, and 12% identified unmet support needs. Inadequacy of tangible support was associated with greater difficulty managing one's health and accessing medications due to COVID-19, as well as poorer medication adherence, increased anxiety and depressive symptoms, and poorer overall well-being ( P 's < .05)., Conclusions: Perceived unmet support needs during stay-at-home orders were associated with greater difficulty engaging in self-management behaviors and poorer overall well-being. Two brief items quickly identified individuals with unmet support needs.