Protocol for a construct and clinical validation study of MyCog Mobile: a remote smartphone-based cognitive screener for older adults.

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.

Remote Self-Administration of Cognitive Screeners for Older Adults Prior to a Primary Care Visit: Pilot Cross-Sectional Study of the Reliability and Usability of the MyCog Mobile Screening App.

BACKGROUND: Routine cognitive screening is essential in the early detection of dementia, but time constraints in primary care settings often limit clinicians' ability to conduct screenings. MyCog Mobile is a newly developed cognitive screening system that patients can self-administer on their smartphones before a primary care visit, which can help save clinics' time, encourage broader screening practices, and increase early detection of cognitive decline. OBJECTIVE: The goal of this pilot study was to examine the feasibility, acceptability, and initial psychometric properties of MyCog Mobile. Research questions included (1) Can older adults complete MyCog Mobile remotely without staff support? (2) Are the internal consistency and test-retest reliability of the measures acceptable? and (3) How do participants rate the user experience of MyCog Mobile? METHODS: A sample of adults aged 65 years and older (N=51) self-administered the MyCog Mobile measures remotely on their smartphones twice within a 2- to 3-week interval. The pilot version of MyCog Mobile includes 4 activities: MyFaces measures facial memory, MySorting measures executive functioning, MySequences measures working memory, and MyPictures measures episodic memory. After their first administration, participants also completed a modified version of the Simplified System Usability Scale (S-SUS) and 2 custom survey items. RESULTS: All participants in the sample passed the practice items and completed each measure. Findings indicate that the Mobile Toolbox assessments measure the constructs well (internal consistency 0.73 to 0.91) and are stable over an approximately 2-week delay (test-retest reliability 0.61 to 0.71). Participants' rating of the user experience (mean S-SUS score 73.17, SD 19.27) indicated that older adults found the usability of MyCog Mobile to be above average. On free-response feedback items, most participants provided positive feedback or no feedback at all, but some indicated a need for clarity in certain task instructions, concerns about participants' abilities, desire to be able to contact a support person or use in-app technical support, and desire for additional practice items. CONCLUSIONS: Pilot evidence suggests that the MyCog Mobile cognitive screener can be reliably self-administered by older adults on their smartphones. Participants in our study generally provided positive feedback about the MyCog Mobile experience and rated the usability of the app highly. Based on participant feedback, we will conduct further usability research to improve support functionality, optimize task instructions and practice opportunities, and ensure that patients feel comfortable using MyCog Mobile. The next steps include a clinical validation study that compares MyCog Mobile to gold-standard assessments and tests the sensitivity and specificity of the measures for identifying dementia.

Cognitive function, self-management, and outcomes among liver transplant recipients: LivCog, a multicenter, prospective study.

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.

Long-term impact of the COVID-19 pandemic on self-management of chronic conditions among high-risk adults in the USA: protocol for the C3 observational cohort study.

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 (T1-T8). Four additional survey waves (T9-T12) 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.

Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm.

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.

LitCog Caregiver Cohort: a prospective, observational cohort study investigating US caregivers' health literacy, self-care skills and cognitive function.

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.

Patient randomised controlled trial of technology enabled strategies to promote treatment adherence in liver transplantation: rationale and design of the TEST trial.

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.

Early COVID-19 Attitudes and Behaviors and Their Associations With Later Infection: A Local Perspective From One U.S. City.

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.

Remote Cognitive Screening Of Healthy Older Adults for Primary Care With the MyCog Mobile App: Iterative Design and Usability Evaluation.

BACKGROUND: Annual cognitive screening in adults aged >65 years can improve early detection of cognitive impairment, yet less than half of all cases are identified in primary care. Time constraints in primary care settings present a major barrier to routine screening. A remote cognitive screener completed on a patient's own smartphone before a visit has the potential to save primary care clinics time, encourage broader screening practices, and increase early detection of cognitive decline. OBJECTIVE: We described the iterative design and proposed the implementation of a remote cognitive screening app, MyCog Mobile, to be completed on a patient's smartphone before an annual wellness visit. The research questions were as follows: What would motivate primary care clinicians and clinic administrators to implement a remote cognitive screening process? How might we design a remote cognitive screener to fit well with existing primary care workflows? What would motivate an older adult patient to complete a cognitive screener on a smartphone before a primary care visit? How might we optimize the user experience of completing a remote cognitive screener on a smartphone for older adults? METHODS: To address research questions 1 and 2, we conducted individual interviews with clinicians (n=5) and clinic administrators (n=3). We also collaborated with clinic administrators to create user journey maps of their existing and proposed MyCog Mobile workflows. To address research questions 3 and 4, we conducted individual semistructured interviews with cognitively healthy older adults (n=5) and solicited feedback from a community stakeholder panel (n=11). We also tested and refined high-fidelity prototypes of the MyCog Mobile app with the older adult interview participants, who rated the usability on the Simplified System Usability Scale and After-Scenario Questionnaire. RESULTS: Clinicians and clinic administrators were motivated to adopt a remote cognitive screening process if it saved time in their workflows. Findings from interviews and user journey mapping informed the proposed implementation and core functionality of MyCog Mobile. Older adult participants were motivated to complete cognitive screeners to ensure that they were cognitively healthy and saw additional benefits to remote screening, such as saving time during their visit and privacy. Older adults also identified potential challenges to remote smartphone screening, which informed the user experience design of the MyCog Mobile app. The average rating across prototype versions was 91 (SD 5.18) on the Simplified System Usability Scale and 6.13 (SD 8.40) on the After-Scenario Questionnaire, indicating above-average usability. CONCLUSIONS: Through an iterative, human-centered design process, we developed a viable remote cognitive screening app and proposed an implementation strategy for primary care settings that was optimized for multiple stakeholders. The next steps include validating the cognitive screener in clinical and healthy populations and piloting the finalized app in a community primary care clinic.

Caregiver health literacy and health task performance: Findings from the LitCog caregiver cohort study.

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.

Persistent loneliness due to COVID-19 over 18 months of the pandemic: A prospective cohort study.

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.

Factors associated with COVID-19 vaccine trust and hesitancy among adults with chronic conditions.

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.

Perceived Adequacy of Tangible Support during Stay-at-Home Orders in Chicago and New York.

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.

Change in Health Literacy over a Decade in a Prospective Cohort of Community-Dwelling Older Adults.

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.