Study Recruitment, Retention, and Adherence Among Chinese American Immigrants During the COVID-19 Pandemic.

BACKGROUND: Chinese American immigrants have been underrepresented in health research partly due to challenges in recruitment. OBJECTIVES: This study aims to describe recruitment and retention strategies and report adherence in a 7-day observational physical activity study of Chinese American immigrants with prior gestational diabetes during the COVID-19 pandemic. METHODS: Foreign-born Chinese women aged 18-45 years, with a gestational diabetes index pregnancy of 0.5-5 years, who were not pregnant and had no current diabetes diagnosis were recruited. They wore an accelerometer for 7 consecutive days and completed an online survey. Multiple recruitment strategies were used: (a) culturally and linguistically tailored flyers, (b) social media platforms (e.g., WeChat [a popular Chinese platform] and Facebook), (c) near-peer recruitment and snowball sampling, and (d) a study website. Retention strategies included flexible scheduling and accommodation, rapid communications, and incentives. Adherence strategies included a paper diary and/or automated daily text reminders with a daily log for device wearing, daily email reminders for the online survey, close monitoring, and timely problem-solving. RESULTS: Participants were recruited from 17 states; 108 were enrolled from August 2020 to August 2021. There were 2,479 visits to the study webpage, 194 screening entries, and 149 inquiries about the study. Their mean age was 34.3 years, and the mean length of U.S. stay was 9.2 years. Despite community outreach, participants were mainly recruited from social media (e.g., WeChat). The majority were recruited via near-peer recruitment and snowball sampling. The retention rate was 96.3%; about 99% had valid actigraphy data, and 81.7% wore the device for 7 days. The majority of devices were successfully returned, and the majority completed the online survey on time. DISCUSSION: We demonstrated the feasibility of recruiting and retaining a geographically diverse sample of Chinese American immigrants with prior gestational diabetes during the COVID-19 pandemic. Recruiting Chinese immigrants via social media (e.g., WeChat) is a viable approach. Nonetheless, more inclusive recruitment strategies are needed to ensure broad representation from diverse socioeconomic groups of immigrants.

Status-neutral community-based multilevel intervention to address intersectional stigma and discrimination, and increase HIV testing, PrEP, and ART uptake among YGBMSM in Ghanaian Slums: A clustered randomized control trial protocol.

Background: While GBMSM constitute less than 2% of Ghana's population, their HIV prevalence surpasses the national average by more than eightfold, emphasizing the critical need for targeted interventions to improve detection, care linkage, and reduce community transmission. This study seeks to increase HIV testing, Pre-Exposure Prophylaxis (PrEP), and Antiretroviral Therapy (ART) uptake (HPART) among YGBMSM through the adaptation of an evidence-based intervention (LAFIYA). Methodology: We will employ the ADAPTT-IT framework to adapt LAFIYA and evaluate its feasibility and effectiveness in addressing intersectional stigma and increasing HPART uptake among YGBMSM residing in Ghanaian slums. In aim 1, we will hold focus groups (n=5) and interviews (n=20) among YGBMSM and two FGDs among GBMSM-led organizations. At the HCF level, we will hold 6 FGDs and interviews (n=20) among nurses. In AIM 2, we will randomly assign 6 healthcare facilities (HCFs) to receive the LAFIYA (n=3) or wait-list control (n=3). Friend groups (cluster) of YGBMSM (N=240) will be assigned to receive LAFIYA (n=120) or a wait-list control (n=120). We will collect 3-, 6-, and 9-months post-intervention data among YGBMSM(n=240) and HCWs(n=300) to measure HPART adherence (primary outcomes), ISD reduction, HIV and status-neutral knowledge (secondary outcomes), and intervention acceptability, appropriateness, and feasibility (implementation outcomes). Conclusion: The intervention group will observe increased HPART adherence, reduced ISD, and enhanced HPART knowledge and efficacy relative to the wait-list control group. The findings will inform ISD reduction and HIV status-neutral implementation strategies - and place-based interventions that address access to HIV prevention and care among YGBMSM, slum and in different settings. Trail Registration: This study was registered on clinicalTrail.gov, with identifier number NCT06312514 on 03/14/2023. https://classic.clinicaltrials.gov/ct2/show/NCT06312514.

The CARING study: Examining biological, behavioral, and genetic mechanisms in the intergenerational transmission of toxic stress.

When children experience extreme or persistent stressors (e.g., maltreatment, housing insecurity, intimate partner violence), prolonged elevation of the stress-response system can lead to disrupted development of multiple physiological systems. This response, known as toxic stress, is associated with poor physical and mental health across the life course. Emerging evidence suggests that the effects of toxic stress may be transmitted through generations, but the biological and behavioral mechanisms that link caregivers' childhood history with the health of the children they care for remain poorly understood. The purpose of this report is to describe the research protocol for The CARING (Childhood Adversity and Resilience In the Next Generation) Study, a cross-sectional study of caregivers with children aged 3-5 years designed to (1) examine the intergenerational transmission of toxic stress and protective factors; (2) explore three hypothesized pathways of transmission: parenting, daily routines, stressors, and supports; and (3) explore the extent to which genotypic variation in candidate genes related to caregiving and stress contribute to caregivers' and children's susceptibility to the effects of early childhood experiences (i.e., gene × environment interactions). We expect that findings from this study will provide critical data needed to identify targets for precision health interventions, reduce health disparities related to toxic stress, and prevent cycles of adversity among families at risk.

Measuring intersectional HIV, sexual diversity, and gender non-conformity stigma among healthcare workers in Ghana: scale validation and correlates of stigma.

BACKGROUND: Men who have sex with men (MSM) are at heightened risk for HIV acquisition, yet they may delay or avoid HIV testing due to intersectional stigma experienced at the healthcare facility (HCF). Few validated scales exist to measure intersectional stigma, particularly amongst HCF staff. We developed the Healthcare Facility Staff Intersectional Stigma Scale (HCF-ISS) and assessed factors associated with stigma in Ghana. METHODS: We analyzed baseline data from HCF staff involved in a study testing a multi-level intervention to reduce intersectional stigma experienced by MSM. Data are from eight HCFs in Ghana (HCF Staff n = 200). The HCF-ISS assesses attitudes and beliefs towards same-sex relationships, people living with HIV (PLWH) and gender non-conformity. Exploratory factor analysis assessed HCF-ISS construct validity and Cronbach's alphas assessed the reliability of the scale. Multivariable regression analyses assessed factors associated with intersectional stigma. RESULTS: Factor analysis suggested an 18-item 3-factor scale including: Comfort with Intersectional Identities in the Workplace (6 items, Cronbach's alpha = 0.71); Beliefs about Gender and Sexuality Norms (7 items, Cronbach's alpha = 0.72); and Beliefs about PLWH (5 items, Cronbach's alpha = 0.68). Having recent clients who engage in same-gender sex was associated with greater comfort with intersectional identities but more stigmatizing beliefs about PLWH. Greater religiosity was associated with stigmatizing beliefs. Infection control training was associated with less stigma towards PLWH and greater comfort with intersectional identities. CONCLUSIONS: Achieving the goal of ending AIDS by 2030 requires eliminating barriers that undermine access to HIV prevention and treatment for MSM, including HCF intersectional stigma. The HCF-ISS provides a measurement tool to support intersectional stigma-reduction interventions.

IL-1 receptor 1 signaling shapes the development of viral antigen-specific CD4+ T cell responses following COVID-19 mRNA vaccination.

BACKGROUND: The innate immune cytokine interleukin (IL)-1 can affect T cell immunity, a critical factor in host defense. In a previous study, we identified a subset of human CD4+ T cells which express IL-1 receptor 1 (IL-1R1). However, the expression of such receptor by viral antigen-specific CD4+ T cells and its biological implication remain largely unexplored. This led us to investigate the implication of IL-1R1 in the development of viral antigen-specific CD4+ T cell responses in humans, including healthy individuals and patients with primary antibody deficiency (PAD), and animals. METHODS: We characterized CD4+ T cells specific for SARS-CoV-2 spike (S) protein, influenza virus, and cytomegalovirus utilizing multiplexed single cell RNA-seq, mass cytometry and flow cytometry followed by an animal study. FINDINGS: In healthy individuals, CD4+ T cells specific for viral antigens, including S protein, highly expressed IL-1R1. IL-1ß promoted interferon (IFN)-γ expression by S protein-stimulated CD4+ T cells, supporting the functional implication of IL-1R1. Following the 2nd dose of COVID-19 mRNA vaccines, S protein-specific CD4+ T cells with high levels of IL-1R1 increased, likely reflecting repetitive antigenic stimulation. The expression levels of IL-1R1 by such cells correlated with the development of serum anti-S protein IgG antibody. A similar finding of increased expression of IL-1R1 by S protein-specific CD4+ T cells was also observed in patients with PAD following COVID-19 mRNA vaccination although the expression levels of IL-1R1 by such cells did not correlate with the levels of serum anti-S protein IgG antibody. In mice immunized with COVID-19 mRNA vaccine, neutralizing IL-1R1 decreased IFN-γ expression by S protein-specific CD4+ T cells and the development of anti-S protein IgG antibody. INTERPRETATION: Our results demonstrate the significance of IL-1R1 expression in CD4+ T cells for the development of viral antigen-specific CD4+ T cell responses, contributing to humoral immunity. This provides an insight into the regulation of adaptive immune responses to viruses via the IL-1 and IL-1R1 interface. FUNDING: Moderna to HJP, National Institutes of Health (NIH) 1R01AG056728 and R01AG055362 to IK and KL2 TR001862 to JJS, Quest Diagnostics to IK and RB, and the Mathers Foundation to RB.

Exploring the feasibility, acceptability and preliminary effects of a nurse delivered mhealth intervention for women living with HIV in South India: a pilot randomized controlled trial.

PURPOSE: We evaluated the feasibility, acceptability and preliminary efficacy of a standardized nurse delivered mobile phone intervention to improve adherence to antiretroviral treatment and clinical outcomes. METHODS: Feasibility and acceptability of the phone intervention was assessed with rates of eligibility, completed visits, and attritions. Intervention fidelity was assessed by checking recorded calls and feedback. Efficacy was assessed using a randomized controlled trial in which 120 women living with HIV and psychosocial vulnerabilities, were randomized to Treatment as Usual (TAU = 60) or TAU plus the mobile phone intervention (N = 60). Trained basic nurses delivered the theory-guided, standardized mobile phone intervention for mental health issues and psychosocial risk factors to improve antiretroviral treatment (ART) adherence and retention in care and improve clinical outcomes. Blind raters performed the assessments at 6, 12 and 24 weeks post-randomization. RESULTS: Adherence diminished over time in the TAU only group, while it was sustained in the TAU Plus group, only dropping at 24 weeks after the intervention had been discontinued. Among participants with depressive symptoms (CESD ≥ 16), the intervention had significant improvement in adherence rates (p < 0.01), psychological quality of life (p < 0.05) and illness perception (p < 0.05) compared to those in the TAU only group. Greater improvements of quality of life subscales were observed in the TAU Plus group among participants with less psychological vulnerability (PSV < 2). HIV RNA was not significantly different between the groups at week 24. CONCLUSIONS: The mobile-delivered counseling intervention was feasible and acceptable and shows promise among women living with HIV and psychosocial vulnerabilities in rural South India. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02319330 [Registered on: December 18, 2014].

Association between adverse childhood experiences and self-reported health-risk behaviors among cancer survivors: A population-based study.

AIMS: Existing evidence shows that people who report Adverse Childhood Experiences (ACEs) are more likely to exhibit health-risk behaviors. However, limited research on this topic pertains to oncology population. We aim to address this knowledge gap by estimating the prevalence of ACEs and investigating their association with self-reported health-risk behaviors among adult cancer survivors living in the U.S. METHODS: We conducted a secondary analysis using cross-sectional data from the 2021 Behavioral Risk Factor Surveillance System ACE module. We included 4,126 adults, aged ≥18 years, with a history of cancer. The outcome variable was self-reported health-risk behaviors, which included cigarette smoking, e-cigarette use, and binge alcohol drinking. Self-reported ACEs history was the primary independent variable, comprised of 11 questions regarding child abuse and dysfunctional households. We conducted descriptive statistics and multivariable logistic regression to describe the relationship between the ACE history and health-risk behaviors. RESULTS: Overall, 84.2% of cancer survivors self-reported as White, 58.4% were women, and 76.6% were aged 65+ years. Nearly two-thirds of the sample (63.2%) self-reported at least one ACE (prior to age 18) and 21.7% engaged in ≥1 health-risk-behaviors, such as cigarette smoking, binge alcohol drinking, or e-cigarette use. Experiencing ≥3 ACEs was associated with 145% increased odds of reporting at least one health-risk behavior (OR = 2.45, 95% CI [1.78-3.38]) when compared to those without a history of ACEs. Besides, survivors who were younger, divorced, less educated, and had low income had higher odds of reporting at least one health-risk behavior. CONCLUSIONS: Overall, a history of ACEs is associated with health-risk behaviors. These all can negatively impact cancer survivors' overall well-being. Early screening for ACE during oncologic visits can be a protective measure for preventing health-risk behaviors among cancer survivors.

Association of Periodic Limb Movements and Obstructive Sleep Apnea With Risk of Cardiovascular Disease and Mortality.

BACKGROUND: Obstructive sleep apnea is a well-established risk factor for cardiovascular disease (CVD). Recent studies have also linked periodic limb movements during sleep to CVD. We aimed to determine whether periodic limb movements during sleep and obstructive sleep apnea are independent or synergistic factors for CVD events or death. METHODS AND RESULTS: We examined data from 1049 US veterans with an apnea-hypopnea index (AHI) <30 events/hour. The primary outcome was incident CVD or death. Cox proportional hazards regression assessed the relationships between the AHI, periodic limb movement index (PLMI), and the AHI×PLMI interaction with the primary outcome. We then examined whether AHI and PLMI were associated with primary outcome after adjustment for age, sex, race and ethnicity, obesity, baseline risk of mortality, and Charlson Comorbidity Index. During a median follow-up of 5.1 years, 237 of 1049 participants developed incident CVD or died. Unadjusted analyses showed an increased risk of the primary outcome with every 10-event/hour increase in PLMI (hazard ratio [HR], 1.08 [95% CI, 1.05-1.13]) and AHI (HR, 1.17 [95% CI, 1.01- 1.37]). Assessment associations of AHI and PLMI and their interaction with the primary outcome revealed no significant interaction between PLMI and AHI. In fully adjusted analyses, PLMI, but not AHI, was associated with an increased risk of primary outcome: HR of 1.05 (95% CI, 1.00-1.09) per every 10 events/hour. Results were similar after adjusting with Framingham risk score. CONCLUSIONS: Our study revealed periodic limb movements during sleep as a risk factor for incident CVD or death among those who had AHI <30 events/hour, without synergistic association between periodic limb movements during sleep and obstructive sleep apnea.

"It's all connected:" A mixed methods study of insomnia, stigma, and discrimination among individuals on medication for opioid use disorder.

OBJECTIVES: Insomnia is one of the most common sleep disorders among those with opioid use disorder (OUD), including those on medication for OUD. There is a dearth of literature exploring the role of social stressors on sleep outcomes among this group. The purpose of this study was to explore the association between OUD-related stigma and intersectional discrimination with insomnia among individuals on medication for OUD. METHODS: Participants were recruited from treatment clinics in the Northeast United States. Using a convergent mixed-methods research design, we explored associations with stigma (The Brief Opioid Stigma Scale), intersectional discrimination (Intersectional Discrimination Index), and insomnia (Insomnia Severity Index) through quantitative survey data and qualitative data from interviews for participant experiences. Data from the quantitative (n = 120) and qualitative (n = 25) components of the study were integrated for interpretation. RESULTS: Quantitative analysis indicated weak to moderate positive correlations between intersectional discrimination, and exploratory variables including pain, perceived stress, and psychological distress with insomnia severity. The qualitative analysis generated 4 main themes, which highlighted negative emotions and ruminations as factors that participants connected experiences with stigma and discrimination to poor sleep outcomes. Integration of data identified concordant and discordant findings. CONCLUSIONS: Stigma, discrimination, physical symptoms, and psychological distress appear to contribute to poor sleep outcomes among those with OUD. Future research should target maladaptive outcomes of rumination and negative emotions to improve sleep outcomes among those with OUD.

Daytime symptom trajectories among adults with stable heart failure and insomnia: evidence from a randomised controlled trial of cognitive behavioural therapy for insomnia.

People with heart failure (HF) experience a high symptom burden and prevalent insomnia. However, little is known about daytime symptom trajectories after cognitive behavioural therapy for insomnia (CBT-I). In this study we describe: (1) daytime symptom trajectories among adults with insomnia and stable HF over 1 year, (2) how symptom trajectories differ between CBT-I versus HF self-management interventions, and (3) associations between demographic, clinical, and sleep characteristics, perceived stress, health-related quality of life (HRQoL), functional performance and daytime symptoms trajectories. We retrospectively analysed data from a randomised controlled trial of CBT-I versus HF self-management (NCT0266038). We measured sleep, perceived stress, HRQoL, and functional performance at baseline and symptoms at baseline, 3, 6, and 12 months. We conducted group-based trajectory modelling, analysis of variance, chi-square, and proportional odds models. Among 175 participants (mean [standard deviation] age 63.0 [12.9] years, 57.1% male, 76% White), we found four daytime symptom trajectories: (A) low improving symptoms (38.3%); (B) low psychological symptoms and high improving physical symptoms (22.8%); (C) high improving symptoms (24.0%); and (D) high not improving symptoms (14.9%). The CBT-I versus the HF self-management group had higher odds of belonging to Group A compared to other trajectories after controlling for baseline fatigue (odds ratio = 3.27, 95% confidence interval 1.39-7.68). The difference between the CBT-I and the HF self-management group was not statistically significant after controlling for baseline characteristics. Group D had the highest body mass index, perceived stress, and insomnia severity and the lowest cognitive ability, HRQoL, and functional performance. Research is needed to further evaluate factors contributing to symptom trajectories.

Leveraging family-based assets for Black men who have sex with men in House Ball Communities: Protocol for a cluster randomized controlled trial.

Black men who have sex with men (MSM) continue to have the highest incidence of new human immunodeficiency virus (HIV) diagnoses in the United States but are least likely to be engaged in care or to be virally suppressed. Many Black MSM face multiple stigmas, but some have found refuge in the House Ball Community (HBC)-a national network of Black lesbian, gay, bisexual, and transgender kinship commitments that provide care-giving, affirmation, and survival skills-building for its members. We propose to modify a skills-building and HIV prevention best-evidence, group-level intervention for HIV- negative Black MSM (Many Men Many Voices) into a family-based intervention to focus on asset-building for both HIV-negative and HIV-positive Black MSM within HBC families. The adapted intervention will be re-branded as Our Family Our Voices (OFOV). We proposed a mixed-methods study to test the feasibility and preliminary efficacy of OFOV adapted for HIV status-neutral use with HBC families. First, we will develop the intervention protocol using the ADAPT-ITT model for modifying behavioral interventions. Then, we will conduct a cluster randomized controlled trial with six HBC families in New York City. Families will be randomized to the OFOV intervention or waitlist control arm. Primary outcomes will be HIV testing, HIV pre-exposure prophylaxis use, currently in HIV care and on HIV treatment. Secondary outcomes will be the number of family-based assets, resilience, number of sexual partners, and relative frequency of condomless anal intercourse. The results of the formative research, including the pilot trial, will contribute to the evidence-base regarding the development of HIV status-neutral interventions that respond to the diversity and complexities of HBC families and that recognize the importance of asset-building for facilitating HBC resilience to stigma as a part of the United States' domestic policy objective of ending the HIV epidemic by 2030.

Costs and Resource Utilization of People with Stable Heart Failure and Insomnia: Evidence from a Randomized Trial of Cognitive Behavioral Therapy for Insomnia.

OBJECTIVES: Nearly half of patients with chronic heart failure (HF) report insomnia symptoms. The purpose of this study was to examine the impact of CBT-I versus HF self-management on healthcare costs and resource utilization among patients with stable chronic HF who participated in a clinical trial of the effects of CBT-I compared to HF self-management education (attention control) over 1 year. METHODS: We measured resource utilization as self-reported (medical record review) physician office visits, emergency department visits, and inpatient admissions at 3-month intervals for 1 year after enrollment. Costs were estimated by applying price weights to visits and adding self-reported out-of-pocket and indirect costs. Univariate comparisons were made of resource utilization and costs between CBT-I and the HF self-management group. A generalized linear model (GLM) was used to model costs, controlling for covariates. RESULTS: The sample included 150 patients [79 CBT-I; 71 self-management (M age = 62 + 13 years)]. The CBT-I group had 4.2 inpatient hospitalizations vs 4.6 for the self-management group (p = .40). There were 13.1 outpatient visits, in the CBT-I compared with 15.4 outpatient visits (p-value range 0.39-0.81) for the self-management group. Total costs were not significantly different in univariate or ($7,813 CBT-I vs. $7,538 self-management), p = .96) or multivariable analyses. CONCLUSIONS: Among patients with both HF and insomnia, CBT-I and HF self-management were associated with similar resource utilization and total costs. Additional research is needed to estimate the value of CBT-I relative to usual care and other treatments for insomnia in patients with HF.

Early emergence of racial and ethnic differences in sleep health among toddlers living in low-income families.

OBJECTIVES: Emerging evidence suggests racial and ethnic and socioeconomic differences in children's sleep health, yet few have examined these differences among very young children. The purpose of this study is to identify potential racial, ethnic, and sociodeomographic factors associated with multiple dimensions of sleep health in toddlers living in very low-income families. PARTICIPANTS: Sample included 110 racially and ethnically diverse dyads with toddlers aged 12-15 months living in low-income families. METHODS: Actigraph data (9 days and nights), caregiver completed sleep diaries, Brief Infant Sleep Questionnaire-extended, and caregiver-reported socioeconomic characteristics were collected. RESULTS: Toddlers' average sleep duration (10.25 hours; SD = 0.76) was less than the age-based recommendations. There were significant race and ethnic differences in toddler's actigraph-measured bedtime (p < .001) and variability in bedtimes (p = .004). Non-LatinX White toddlers had earlier bedtimes and less variability than Black and LatinX children. These between-group differences remained statistically significant after controlling for measured socioeconomic variables (p's < 0.001). Within racial and ethnic group differences in bedtime and bedtime variability by education, employment, and marital status were identified with medium to large effect sizes. CONCLUSIONS: Racial and ethnic between-group differences in sleep occurred as early as 12 months of age and were not explained by sociodemographic variables (eg, income-to-needs, education, housing). Further research is necessary to determine structural and contextual factors that explain the racial and ethnic differences in sleep health in early childhood. Identifying these factors may inform the development of socially and culturally tailored interventions to reduce sleep health disparities.

Longitudinal associations among physical activity, inflammatory markers, and quality of life in patients with head and neck cancer.

INTRODUCTION: The aim of this study was to explore the associations among physical activity (PA), inflammatory markers, and quality of life (QoL) from preradiotherapy to 1-year postradiotherapy for patients with head and neck cancer (HNC). METHODS: This was an observational longitudinal study. Mixed-effect models incorporating within-subject correlation were used to examine the relationship among the three key variables. RESULTS: Aerobically active patients had significantly lower levels of sTNFR2 (but not other inflammatory markers) than aerobically inactive patients. Being aerobically active and lower inflammation were independently associated with better total QoL scores after adjusting covariates. The trend was similar for patients engaged in strength exercises. CONCLUSIONS: Being aerobically active was associated with lower inflammation as represented by sTNFR2 but not with other inflammatory markers. Higher PA (aerobic and strength) and lower inflammation were linked to better QoL. More research is warranted to validate the association among PA, inflammation, and QoL.

Applying person-centered research ethics in the design of dementia-specific measures.

There is an emerging call for new strengths-based measures to guide research, care, and support for persons living with Alzheimer's disease and related dementias. Person-centered interventions have demonstrated a positive impact in global quality of life, but many promising approaches lack strengths-based measures with sufficient sensitivity to document relevant outcomes. Human centered design is an innovative method for person-centered instrument development. This paper describes a research process using Human Centered Design and highlights ethical principles considered during the translation of the design process to experiential world of Alzheimer's disease and related dementia. Including persons living with dementia and care partners as members of the design team offers new insights, while requiring focused attention on inclusivity, transparency, and person-centered ethics.

Rest-activity rhythms predict time to hospitalizations and emergency department visits among participants in a randomized control of adults with heart failure and insomnia.

BACKGROUND: We examined the effects of insomnia and diurnal rest-activity rhythms (RARs) on time to hospitalizations and emergency department (ED) visits in a randomized controlled trial of cognitive behavioral therapy for insomnia among people with chronic heart failure (HF) and insomnia. METHODS: Among 168 HF patients, we measured insomnia, CPAP use, sleep, symptoms, and 24-h wrist actigraphy and computed the circadian quotient (strength of the RAR) from wrist actigraphy and computed cox-proportional hazard and frailty models. RESULTS: Eighty-five (50.1%) and ninety-one (54.2%) participants had at least one hospitalization or ED visit, respectively. NYHA class and comorbidity predicted time to hospitalizations and ED visits, while younger age and male sex predicted earlier hospitalizations. Low ejection fraction predicted time to first cardiac event and composite events. Independent of clinical and demographic predictors, a lower circadian quotient and more severe pain significantly predicted earlier hospitalizations. A more robust circadian quotient, more severe insomnia, and fatigue predicted earlier ED visits independent from clinical and demographic factors. Pain and fatigue predicted composite events. CONCLUSION: Insomnia severity and RARs independently predicted hospitalizations and ED visits independent of clinical and demographic variables. Further research is necessary to determine whether improving insomnia and strengthening RARs improves outcomes among people with HF. CLINICAL TRIALS REGISTRATION: NCT02660385.

Sleep-related predictors of cognition among adults with chronic insomnia and heart failure enrolled in a randomized controlled trial of cognitive behavioral therapy for insomnia.

STUDY OBJECTIVES: Cognitive impairment and insomnia are common in chronic heart failure (HF). We examined the effects of cognitive behavioral therapy for insomnia (CBT-I) and the extent to which demographic, clinical, symptom, and functional characteristics predicted cognition among people with chronic HF and insomnia who participated in a randomized controlled trial of CBT-I. METHODS: Participants with HF were randomized to group-based CBT-I or an attention control (HF self-management education). Outcomes were measured over 1 year. We measured psychomotor vigilance and self-reported cognitive ability (PROMIS Cognitive Abilities Scale), clinical and demographic characteristics, history of sleep apnea, fatigue, pain, insomnia (Insomnia Severity Index), sleepiness (Epworth Sleepiness Scale), Six Minute Walk, EuroQoL Quality of Life, and wrist actigraphy (sleep characteristics and rest-activity rhythms). We used cosinor analysis to compute rest-activity rhythms and general linear models and general estimating equations to test the effects of predictors over 1 year. RESULTS: The sample included 175 participants (mean age = 63 SD = 12.9 Years; 43% women). There was a statistically significant group-time effect on self-reported cognitive function and increases in the proportion of participants, with < 3 psychomotor vigilance lapses in the CBT-I group. Controlling for group-time effects and baseline cognition, decreased sleepiness, improved rest-activity rhythms, and 6-minute walk distance predicted a composite measure of cognition (psychomotor vigilance lapses and self-reported cognition). CONCLUSIONS: CBT-I may improve cognition in adults with chronic HF. A future fully powered randomized controlled trial is needed to confirm the extent to which CBT-I improves multiple dimensions of cognition. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Cognitive Behavioral Therapy for Insomnia: A Self-Management Strategy for Chronic Illness in Heart Failure; URL: https://clinicaltrials.gov/ct2/show/NCT02660385; Identifier: NCT02660385. CITATION: Redeker NS, Conley S, O'Connell M, Geer JH, Yaggi H, Jeon S. Sleep-related predictors of cognition among adults with chronic insomnia and heart failure enrolled in a randomized controlled trial of cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2023;19(6):1073-1081.

Measurement invariance of the 10-item resilience scale specific to cancer in Americans and Chinese: A propensity score-based multidimensional item response theory analysis.

Objective: Little is known about the measurement invariance (MI) of resilience instruments in cancer care. This study was designed to examine MI of 10-Item Resilience Scale (RS-SC-10) in Americans and Chinese with cancer using propensity score-based multidimensional item response theory (MIRT) analysis. Methods: A sample of 924 patients were enrolled in the Be Resilient to Cancer trial involving 1 hospital in America and 3 hospitals in China. Data were collected from the RS-SC-10 and Hospital Anxiety and Depression Scale. Propensity score matching and MIRT were performed to evaluate Differential Item Function. Integrated Discrimination Improvement and Net Reclassification Improvement were used to indirectly estimate the MI through incremental prediction ability of MIRT-based score over total score. Results: RS-SC-10 retained 10 items with monotonous thresholds and its original two-factor structure. Nonuniform Differential Item Function was recognized in Item 4 (P â€‹= â€‹0.0011, Δ%ß1 â€‹= â€‹4.15%) and Item 8 (P â€‹= â€‹0.0017, Δ%ß1 â€‹= â€‹5.99%). Net Reclassification Improvement ranged from 9.04% to 35.01%, and Integrated Discrimination Improvement ranged from 8.82% to 20.60%. Conclusions: Although partial MI has been identified between Americans and Chinese, RS-SC-10 remains a critical indicator to emotional distress in cancer care.

Personalized Digital Health Information to Substantiate Human-Delivered Exercise Support for Adults With Type 1 Diabetes.

OBJECTIVE: Pilot-test personalized digital health information to substantiate human-delivered exercise support for adults with type 1 diabetes (T1D). DESIGN: Single-group, 2-week baseline observation, then 10-week intervention with follow-up observation. SETTING: Community-based sample participating remotely with physician oversight. PARTICIPANTS: Volunteers aged 18 to 65 years with T1D screened for medical readiness for exercise intervention offerings. N = 20 enrolled, and N = 17 completed all outcomes with 88% to 91% biosensor adherence. INTERVENTION: Feedback on personalized data from continuous glucose monitoring (CGM), its intersection with other ecological data sets (exercise, mood, and sleep), and other informational and motivational elements (exercise videos, text-based exercise coach, and self-monitoring diary). MAIN OUTCOME MEASURES: Feasibility (use metrics and assessment completion), safety (mild and severe hypoglycemia, and diabetic ketoacidosis), acceptability (system usability scale, single items, and interview themes), and standard clinical and psychosocial assessments. RESULTS: Participants increased exercise from a median of 0 (Interquartile range, 0-21) to 64 (20-129) minutes per week ( P = 0.001, d = 0.71) with no severe hypoglycemia or ketoacidosis. Body mass index increased (29.5 ± 5.1 to 29.8 ± 5.4 kg/m 2 , P = 0.02, d = 0.57). Highest satisfaction ratings were for CGM use (89%) and data on exercise and its intersection with CGM and sleep (94%). Satisfaction was primarily because of improved exercise management behavioral skills, although derived motivation was transient. CONCLUSIONS: The intervention was feasible, safe, and acceptable. However, there is a need for more intensive, sustained support. Future interventions should perform analytics upon the digital health information and molecular biomarkers (eg, genomics) to make exercise support tools that are more personalized, automated, and intensive than our present offerings.

Symptom Cluster Profiles Among Adults with Insomnia and Heart Failure.

OBJECTIVE/BACKGROUND: Both heart failure (HF) and insomnia are associated with high symptom burden that may be manifested in clustered symptoms. To date, studies of insomnia have focused only on its association with single symptoms. The purposes of this study were to: (1) describe daytime symptom cluster profiles in adults with insomnia and chronic HF; and (2) determine the associations between demographic and clinical characteristics, insomnia and sleep characteristics and membership in symptom cluster profiles. PARTICIPANTS: One hundred and ninety-five participants [M age 63.0 (SD12.8); 84 (43.1%) male; 148 (75.9%) New York Heart Association Class I/II] from the HeartSleep study (NCT0266038), a randomized controlled trial of the sustained effects of cognitive behavioral therapy for insomnia (CBT-I). METHODS: We analyzed baseline data, including daytime symptoms (fatigue, pain, anxiety, depression, dyspnea, sleepiness) and insomnia (Insomnia Severity Index), and sleep characteristics (Pittsburgh Sleep Quality Index, wrist actigraphy). We conducted latent class analysis to identify symptom cluster profiles, bivariate associations, and multinomial regression. RESULTS: We identified three daytime symptom cluster profiles, physical (N = 73 participants; 37.4%), emotional (N = 12; 5.6%), and all-high symptoms (N = 111; 56.4%). Body mass index, beta blockers, and insomnia severity were independently associated with membership in the all-high symptom profile, compared with the other symptom profile groups. CONCLUSIONS: Higher symptom burden is associated with more severe insomnia in people with stable HF. There is a need to understand whether treatment of insomnia improves symptom burden as reflected in transition from symptom cluster profiles reflecting higher to lower symptom burden.