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.

Impact of COVID-19 on the capacity to self-manage health and chronic conditions.

Objective: To investigate well-being, lifestyle behaviors, self-management capacity and healthcare utilization among adults with chronic conditions at the outbreak of the COVID-19 pandemic. Methods: Data was collected from two interviewer-administered telephone surveys conducted between March 27 - May 22, 2020. Participants were patients at Chicago-area clinics. Self-report and validated measures were used for study-related outcomes. Results: A total of 553 participants (age range 23-88) completed data collection at both timepoints. One in five (20.7%) participants experienced stress due to the coronavirus most or all the time and rates of negative well-being were high (WHO-5 Index mean = 58.7%). Almost a quarter (22.3%) engaged in hazardous drinking and 79.7% reported insufficient physical activity. Nearly one in four participants (23.7%) avoided seeking medical care due to worry about COVID-19. In multivariable analyses, greater COVID-19 related stress was associated with less physical activity, lower self-efficacy, greater difficulty managing health and medications, and delays in seeking medical care due to the coronavirus. Conclusions: Mental well-being, lifestyle behaviors, self-management capacity, and healthcare utilization were impacted in the months following the COVID outbreak. Innovation: These findings suggest health systems should implement proactive measures for detecting and treating emotional and behavioral COVID-related concerns.

MidCog study: a prospective, observational cohort study investigating health literacy, self-management skills and cognitive function in middle-aged adults.

INTRODUCTION: The lack of definitive means to prevent or treat cognitive impairment or dementia is driving intense efforts to identify causal mechanisms. Recent evidence suggests clinically meaningful declines in cognition might present as early as middle age. Studying cognitive changes in middle adulthood could elucidate modifiable factors affecting later cognitive and health outcomes, yet few cognitive ageing studies include this age group. The purpose of the MidCog study is to begin investigations of less-studied and potentially modifiable midlife determinants of later life cognitive outcomes. METHODS AND ANALYSIS: MidCog is a prospective cohort study of adults ages 35-64, with two in-person interviews 2.5 years apart. Data will be collected from interviews, electronic health records and pharmacy fill data. Measurements will include health literacy, self-management skills, cognitive function, lifestyle and health behaviours, healthcare use, health status and chronic disease outcomes. Associations of health literacy and self-management skills with health behaviours and cognitive/health outcomes will be examined in a series of regression models, and moderating effects of modifiable psychosocial factors.Finally, MidCog data will be linked to an ongoing, parallel cohort study of older adults recruited at ages 55-74 in 2008 ('LitCog'; ages 70-90 in 2023), to explore associations between age, health literacy, self-management skills, chronic diseases, health status and cognitive function among adults ages 35-90. ETHICS AND DISSEMINATION: The Institutional Review Board at Northwestern University has approved the MidCog study protocol (STU00214736). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study as well as patients.

Trajectories of Sleep Disturbance and Self-Management of Chronic Conditions during COVID-19 among Middle-aged and Older Adults.

Background: The COVID-19 pandemic has had a widespread impact on sleep quality, yet little is known about the prevalence of sleep disturbance and its impact on self-management of chronic conditions during the ongoing pandemic. Objective: To evaluate trajectories of sleep disturbance, and their associations with one's capacity to self-manage chronic conditions. Design: A longitudinal cohort study linked to 3 active clinical trials and 2 cohort studies with 5 time points of sleep data collection (July 15, 2020 - May 23, 2022). Participants: Adults living with chronic conditions who completed sleep questionnaires for two or more time points. Exposure: Trajectories of self-reported sleep disturbance across 5 time points. Main Outcomes: 3 self-reported measures of self-management capacity, including subjective cognitive decline, medication adherence, and self-efficacy for managing chronic disease. Results: 549 adults aged 23 to 91 years were included in the analysis. Two thirds had 3 or more chronic conditions; 42.4% of participants followed a trajectory of moderate or high likelihood of persistent sleep disturbance across the study period. Moderate or high likelihood of sleep disturbance was associated with older age (RR 1.57, 95% CI 1.09, 2.26, P<.05), persistent stress (RR 1.54, 95% CI 1.16, 2.06, P=.003), poorer physical function (RR 1.57, 95% CI 1.17, 2.13, P=.003), greater anxiety (RR 1.40, 95% CI 1.04, 1.87, P=.03) and depression (RR 1.63, 95% CI 1.20, 2.22, P=.002). Moderate or high likelihood of sleep disturbance was also independently associated with subjective cognitive decline, poorer medication adherence, and worse self-efficacy for managing chronic diseases (all P<.001). Conclusions: Persistent sleep disturbance during the pandemic may be an important risk factor for inadequate chronic disease self-management and potentially poor health outcomes in adults living with chronic conditions. Public health and health system strategies might consider monitoring sleep quality in adults with chronic conditions to optimize health outcomes.

Prevalence and risk factors of sleep disturbance in adults with underlying health conditions during the ongoing COVID-19 pandemic.

To determine the prevalence of sleep disturbance during the coronavirus disease 2019 (COVID-19) pandemic among US adults who are more vulnerable to complications because of age and co-morbid conditions, and to identify associated sociodemographic and psychosocial factors. Cross-sectional survey linked to 3 active clinical trials and 2 cohort studies, conducted between 11/30/2020 and 3/3/2021. Five academic internal medicine practices and 2 federally qualified health centers. A total of 715 adults ages 23 to 91 years living with one or more chronic conditions. A fifth (20%) of participants reported poor sleep. Black adults were twice as likely to report poor sleep compared to Whites. Self-reported poor physical function (51%), stress (42%), depression (28%), and anxiety (36%) were also common and all significantly associated with poor sleep. Age ≥70 years and having been vaccinated for COVID-19 were protective against poor sleep. Sex, education, income, alcohol use, and employment status were not significantly associated with sleep quality. In this diverse sample of adults with chronic conditions, by race, ethnicity, and socioeconomic status, disparities in sleep health amid the ongoing pandemic were apparent. Worse physical function and mental health were associated with poor sleep and should be considered targets for health system interventions to prevent the many subsequent consequences of disturbed sleep on health outcomes. Measurements: self-reported sleep quality, physical function, stress, depression, and anxiety.

A Multifaceted Intervention to Improve Medication Adherence in Kidney Transplant Recipients: An Exploratory Analysis of the Fidelity of the TAKE IT Trial.

BACKGROUND: Inadequate adherence to prescribed immunosuppressive medication regimens among kidney transplant recipients is common, yet interventions are needed to support patients in sustaining adequate adherence to prescribed regimens and achieving optimal transplant outcomes. OBJECTIVE: We examined the preliminary fidelity of a transplant center-based, multifaceted adherence monitoring strategy known as TAKE IT. METHODS: The TAKE IT strategy includes: (1) routine, online, monthly patient self-report adherence assessments; (2) care alerts directed to nurses; (3) quarterly reports monitoring tacrolimus values and adherence trends; (4) support tools tailored to specific adherence concerns. A 2-arm, patient-randomized trial is underway at two large transplant centers (N=449). To evaluate the initial fidelity of TAKE IT, we investigated patient uptake of monthly adherence assessments during the course of a 3-month period, whether any disparities emerged, and the nature of any reported adherence concerns. RESULTS: Among 202 patients randomized and exposed to TAKE IT for 3-months or more, 81% (164/202) completed an adherence assessment, 73% (148/202) completed at least two, and 57% (116/202) completed all monthly assessments. Overall, 50% (82/164) of kidney transplant recipients reported at least one adherence concern over the 3-month assessment period. The most common barriers were classified as regimen-related (eg, regimen complexity), cognitive (eg, forgetfulness), and medical (eg, side effects). Higher-income participants were more likely to complete all surveys compared to lower-income participants (P=.01). CONCLUSIONS: TAKE IT demonstrated 81% (164/202) completion of an adherence assessment, 73% (148/202) completion of at least two, and 57% (116/202) completion of all monthly assessments during this brief, initial observation period. Among those that did respond to the online assessments, the majority demonstrated sustained engagement. Additional monitoring modalities could also be offered to meet patient preferences to ensure all patients' medication use can be properly monitored. TRIAL REGISTRATION: ClinicalTrials.gov NCT03104868; https://clinicaltrials.gov/ct2/show/NCT03104868.

Changes in COVID-19 Knowledge, Beliefs, Behaviors, and Preparedness Among High-Risk Adults from the Onset to the Acceleration Phase of the US Outbreak.

BACKGROUND: The US outbreak of coronavirus disease 2019 (COVID-19) accelerated rapidly over a short time to become a public health crisis. OBJECTIVE: To assess how high-risk adults' COVID-19 knowledge, beliefs, behaviors, and sense of preparedness changed from the onset of the US outbreak (March 13-20, 2020) to the acceleration phase (March 27-April 7, 2020). DESIGN: Longitudinal, two-wave telephone survey. PARTICIPANTS: 588 predominately older adults with ≥ 1 chronic condition recruited from 4 active, federally funded studies in Chicago. MAIN MEASURES: Self-reported knowledge of COVID-19 symptoms and prevention, related beliefs, behaviors, and sense of preparedness. KEY RESULTS: From the onset to the acceleration phase, participants increasingly perceived COVID-19 to be a serious public health threat, reported more changes to their daily routine and plans, and reported greater preparedness. The proportion of respondents who believed they were "not at all likely" to get the virus decreased slightly (24.9 to 22.4%; p = 0.04), but there was no significant change in the proportion of those who were unable to accurately identify ways to prevent infection (29.2 to 25.7%; p 0.14). In multivariable analyses, black adults and those with lower health literacy were more likely to report less perceived susceptibility to COVID-19 (black adults: relative risk (RR) 1.62, 95% confidence interval (CI) 1.07-2.44, p = 0.02; marginal health literacy: RR 1.96, 95% CI 1.26-3.07, p < 0.01). Individuals with low health literacy remained more likely to feel unprepared for the outbreak (RR 1.80, 95% CI 1.11-2.92, p = 0.02) and to express confidence in the federal government response (RR 2.11, 95% CI 1.49-3.00, p < 0.001) CONCLUSIONS: Adults at higher risk for COVID-19 continue to lack critical knowledge about prevention. While participants reported greater changes to daily routines and plans, disparities continued to exist in perceived susceptibility to COVID-19 and in preparedness. Public health messaging to date may not be effectively reaching vulnerable communities.

Awareness, Attitudes, and Actions Related to COVID-19 Among Adults With Chronic Conditions at the Onset of the U.S. Outbreak: A Cross-sectional Survey.

BACKGROUND: The evolving outbreak of coronavirus disease 2019 (COVID-19) is requiring social distancing and other measures to protect public health. However, messaging has been inconsistent and unclear. OBJECTIVE: To determine COVID-19 awareness, knowledge, attitudes, and related behaviors among U.S. adults who are more vulnerable to complications of infection because of age and comorbid conditions. DESIGN: Cross-sectional survey linked to 3 active clinical trials and 1 cohort study. SETTING: 5 academic internal medicine practices and 2 federally qualified health centers. PATIENTS: 630 adults aged 23 to 88 years living with 1 or more chronic conditions. MEASUREMENTS: Self-reported knowledge, attitudes, and behaviors related to COVID-19. RESULTS: A fourth (24.6%) of participants were "very worried" about getting the coronavirus. Nearly a third could not correctly identify symptoms (28.3%) or ways to prevent infection (30.2%). One in 4 adults (24.6%) believed that they were "not at all likely" to get the virus, and 21.9% reported that COVID-19 had little or no effect on their daily routine. One in 10 respondents was very confident that the federal government could prevent a nationwide outbreak. In multivariable analyses, participants who were black, were living below the poverty level, and had low health literacy were more likely to be less worried about COVID-19, to not believe that they would become infected, and to feel less prepared for an outbreak. Those with low health literacy had greater confidence in the federal government response. LIMITATION: Cross-sectional study of adults with underlying health conditions in 1 city during the initial week of the COVID-19 U.S. outbreak. CONCLUSION: Many adults with comorbid conditions lacked critical knowledge about COVID-19 and, despite concern, were not changing routines or plans. Noted disparities suggest that greater public health efforts may be needed to mobilize the most vulnerable communities. PRIMARY FUNDING SOURCE: National Institutes of Health.