Estimating the budget impact of a Tuberculosis strategic purchasing pilot study in Medan, Indonesia (2018-2019).

BACKGROUND: Indonesia has the world's second-highest tuberculosis (TB) burden, with 969,000 annual TB infections. In 2017, Indonesia faced significant challenges in TB care, with 18% of cases missed, 29% of diagnosed cases unreported, and 55.4% of positive results not notified. The government is exploring a new approach called "strategic purchasing" to improve TB detection and treatment rates and offer cost-effective service delivery. OBJECTIVES: We aimed to analyze the financial impact of implementing a TB purchasing pilot in the city of Medan and assess the project's affordability and value for money. METHODS: We developed a budget impact model to estimate the cost-effectiveness of using strategic purchasing to improve TB reporting and treatment success rates. We used using data from Medan's budget impact model and the Ministry of Health's guidelines to predict the total cost and the cost per patient. RESULTS: The model showed that strategic purchasing would improve TB reporting by 63% and successful treatments by 64%. While this would lead to a rise in total spending on TB care by 60%, the cost per patient would decrease by 3%. This is because more care would be provided in primary healthcare settings, which are more cost-effective than hospitals. CONCLUSIONS: While strategic purchasing may increase overall spending, it could improve TB care in Indonesia by identifying more cases, treating them more effectively, and reducing the cost per patient. This could potentially lead to long-term cost savings and improved health outcomes.

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.

Experiences of Stigma and Discrimination Compounded by Intersecting Identities among Individuals Receiving Medication for Opioid Use Disorder.

Stigma and discrimination create barriers to care among people receiving medication for opioid use disorder (MOUD). We report qualitative findings from a mixed methods study guided by three aims: to explore (1) intersecting identities of people receiving MOUD (2) how individuals experience stigma and discrimination and (3) helpful resources in addressing cumulative experiences of multiple forms of disadvantage. We conducted interviews with 25 individuals in three treatment centers in the Northeast United States and identified six themes: (1) Living with multiple socially marginalized identities and addiction; (2) Loss; (3) "It's everywhere": Discrimination and stigma; (4) A "damaged" identity, (5) Positive responses to negative experiences: Facing reality and becoming accountable, and (6) Experiencing treatment and identifying supportive interventions. Findings highlight the complexity of intersecting, marginalized social positions. Future work should look beyond one-size-fits-all approaches to care and recognize individual vulnerabilities and strengths for improving outcomes among those experiencing OUD.

Focus Group Study of Heart Failure Nurses' Perceptions of the Feasibility of Cognitive Behavioral Therapy for Insomnia.

BACKGROUND: People with heart failure (HF) often report insomnia with daytime consequences, including fatigue and decreased functional performance. Cognitive behavioral therapy for insomnia is an efficacious treatment, but few have access because of a shortage of trained sleep specialists. Access may be improved by offering it where people with HF receive care. OBJECTIVES: The purpose of this study was to explore the perceptions of nurses who specialize in HF regarding the value of cognitive behavioral therapy for insomnia to their patients, the feasibility of offering it in HF clinical settings, its delivery by nurses, and preferences for modes of delivery. METHODS: We used a descriptive qualitative study design. We recruited focus group participants via e-mail to American Association of Heart Failure Nurses members and through requests for nurse collaborators to distribute within their networks. We conducted focus groups via Zoom. After describing cognitive behavioral therapy for insomnia and its efficacy for people with HF, we elicited perceptions about its value if provided in the HF outpatient clinical setting, facilitators and barriers to implementation, and other ways to increase access. We audio-recorded and transcribed the discussions. Two researchers coded the data and performed thematic analysis. RESULTS: Four focus groups included 23 registered nurses and advanced practice nurses employed in outpatient HF clinics. We identified five themes: "Insomnia Overlooked," "Cognitive Behavioral Therapy for Insomnia Works," "Nurses' Role," "Barriers and Supports," and "Modes of Delivery." Nurses endorsed the importance of insomnia to people with HF and the value of providing cognitive behavioral therapy. They expressed interest in evaluating and addressing sleep, the need for increased resources to address it, and multiple modes of delivery. All nurses believed they had a role in promoting sleep health but differed in their views about providing cognitive behavioral therapy for insomnia. DISCUSSION: Nurses specializing in HF support the implementation of cognitive behavioral therapy for insomnia. Implementation studies are needed to identify effective methods to increase access to this efficacious treatment in outpatient HF clinical settings, including support and training for nurses who are interested and able to deliver it.

"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.

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.

Something Has to Give: An Urban Community-Engaged Focus Group Study of Teen Sleep.

Sleep is critical to teen physical and mental health, daily function, and school performance. Yet, sleep deficiency is prevalent among ethnoracially diverse teens. The purpose of this community-engaged focus group study was to explore multilevel influences on teen sleep from teen and community stakeholder perspectives and to use this information to develop a tailored sleep health intervention. We conducted seven focus groups (N = 46) and analyzed data via content analysis. Five themes, each with subthemes, described sleep knowledge/attitudes, sleep habits, the multilevel causes and consequences of decreased nighttime sleep and suggestions for improving teen sleep. Teen health, mood, and school engagement were all impacted by inadequate nighttime sleep. Exhaustion emerged as an overarching theme and coincided with the transition to high school. The data from this study provide insight into important areas of focus for a sleep intervention tailored to the needs of ethnoracially diverse teens living in an urban community.

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.

Facilitating the Urgent Public Health Need to Improve Data Sharing With Tribal Epidemiology Centers.

Tribal Epidemiology Centers (TECs) are an essential and unique part of the public health system and an important part of federal efforts to improve the health status of American Indian and Alaska Native people. Pursuant to federal statute, TECs serve the 574 federally recognized Tribes (hereinafter, "Tribes") and their members across the United States, as well as American Indian and Alaska Native people in general. The COVID-19 pandemic has highlighted the need for timely, complete, and accurate public health data, particularly for American Indian and Alaska Native communities and others who may have been disproportionately impacted by COVID-19. This article reviews the history and importance of TECs and federal statutes governing TECs' ability to access and use protected health information for public health purposes. TECs and Tribes often encounter difficulty receiving public health data from state and federal agencies despite their designation as "public health authorities" under the Health Insurance Portability and Accountability Act and associated regulations. Limited access to this information hinders the statutory mission of TECs as well as Tribal monitoring of and response to public health threats such as SARS-CoV-2. Agency acknowledgment and compliance with current federal law regarding data sharing with TECs are essential to improve data access and the fragile public health of Tribal communities.

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.

Sleep, Stress, and Symptoms Among People With Heart Failure During the COVID-19 Pandemic.

BACKGROUND: The COVID-19 pandemic raised concerns about the effects of stress on sleep and mental health, particularly among people with chronic conditions, including people with heart failure (HF). OBJECTIVE: The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with HF who participated in a randomized controlled trial of cognitive behavioral therapy for insomnia before the COVID-19 pandemic. METHODS: Participants self-reported sleep characteristics, symptoms, mood, and stress at baseline, 6 months after cognitive behavioral therapy for insomnia or HF self-management education (attention control), and during the pandemic. RESULTS: The sample included 112 participants (mean age, 63 ± 12.9 years; 47% women; 13% Black; 68% New York Heart Association class II or III). Statistically significant improvements in sleep, stress, mood, and symptoms that occurred 6 months post treatment were sustained during the pandemic. CONCLUSIONS: Improving sleep and symptoms among people with HF may improve coping during stressful events, and cognitive behavioral therapy for insomnia may be protective.

Correlates of cognition among people with chronic heart failure and insomnia.

PURPOSE: This study aimed to describe cognitive characteristics and their associations with demographic and clinical factors among adults with chronic heart failure (HF) and insomnia. METHODS: We performed a cross-sectional analysis of baseline data from the HeartSleep Study (NCT#02,660,385), a randomized controlled trial designed to evaluate the effects of cognitive-behavioral therapy for insomnia. Demographic characteristics and health history were obtained. We measured sleep characteristics with the Insomnia Severity Index, the PROMIS Sleep Disturbance Questionnaire, and wrist actigraphy. Sleepiness, stress, and quality of life were measured with validated questionnaires. Measures of cognition included frequency of lapses on the psychomotor vigilance test and the PROMIS cognitive abilities scale where ≥ 3 lapses and a score of ≤ 50, respectively, suggested impairment. These variables were combined into a composite score for multivariable analyses. RESULTS: Of a sample that included 187 participants (58% male; mean age 63.1 [SD = 12.7]), 77% had New York Heart Association class I or II HF and 66% had HF with preserved ejection fraction. Common comorbidities were diabetes (35%), hypertension (64%), and sleep apnea (54%). Impaired vigilant attention was associated with non-White race, higher body mass index, less education, and more medical comorbidities. Self-reported cognitive impairment was associated with younger age, higher body mass index, and pulmonary disease. On adjusted analysis, significant risk factors for cognitive impairment included hypertension (OR 1.94), daytime sleepiness (OR 1.09), stress (OR 1.08), and quality of life (OR 0.12). CONCLUSIONS: Impaired cognition is common among people with chronic HF and insomnia and associated with hypertension, daytime sleepiness, stress, and poor quality of life. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: Insomnia Self-management in Heart Failure; NCT#02,660,385.

Coping, symptoms, and insomnia among people with heart failure during the COVID-19 pandemic.

AIMS: Increases in stress, symptoms of anxiety and depression, and sleep problems have been reported during the Covid-19 pandemic, and people with chronic medical conditions such as heart failure (HF) are especially vulnerable. The purpose of this study was to examine the extent to which sleep characteristics, sleep-related cognitions, anxiety, depression, perceived stress, and changes in these phenomena over time predict ways of coping with pandemic-related stress among participants in the HeartSleep study, a randomized controlled trial of the effects of cognitive behavioural therapy for insomnia (CBT-I) in people with HF. METHODS AND RESULTS: Participants completed questionnaires to elicit sleep characteristics, daytime symptoms, mood and stress at baseline, 6 months after the intervention and during the Covid-19 pandemic. We added measures of coping during the pandemic (June-August 2020). The sample included 112 participants (M age = 63 ± 12.9 years; 47% women; 13% Black; 68% NY Heart Class II or III). Participants (43%) reported pandemic-related stressors and most often used secondary control coping. Insomnia severity, anxiety, depression, perceived stress, and sleep-related cognitions predicted secondary control coping (positive thinking, cognitive restructuring, acceptance, distraction), involuntary engagement (physiological arousal, rumination), and involuntary disengagement (emotional numbing). CONCLUSIONS: Insomnia and mood disturbance are important determinants of coping and responses to stress. Improving sleep and symptoms among people with HF may improve coping during stressful events, and CBT-I may have protective effects. REGISTRATION: ClinicalTrials.gov: NCT02660385.

Trajectory of self-care in people with stable heart failure and insomnia after two self-care interventions.

OBJECTIVE: To describe (1) self-care trajectories among adults with heart failure (HF) and insomnia over 1-year; (2) the extent to which trajectories varied between cognitive behavioral therapy for insomnia (CBT-I) or HF self-care intervention; and (3) the associations between self-care trajectories and clinical and demographic characteristics, sleep, symptoms and stress, and functional performance. METHODS: We conducted secondary analysis of data from a randomized controlled trial of the effects of CBT-I compared with HF self-care education among adults with stable HF and insomnia. We used the Self-Care of Heart Failure Index v6.2. The analytic approaches included t-tests, group-based trajectory modeling, ANOVA, and chi-square. RESULTS: We included 175 participants (M age=63.0 (12.9) years, White, N = 100]. We found four self-care trajectories: Low self-care (N = 47, 26.8%); Moderate self-care (N = 68, 38.9%): Adequate self-care (N = 42, 24.0%); and Optimal self-care (N = 18, 10.3%). There was no difference in self-care trajectories between interventions. The low self-care group had the most severe baseline fatigue, anxiety, and perceived stress, and lowest cognitive abilities. CONCLUSION: Both interventions prevented declining self-care. Future research is needed to determine the most efficacious intervention to improve self-care trajectories. PRACTICE IMPLICATIONS: Healthcare providers should provide ongoing self-care support for those with persistently low and moderate self-care.

Treatment Fidelity in a Randomized Controlled Trial of Cognitive Behavioral Therapy for Insomnia in Heart Failure.

BACKGROUND: Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious treatment for people with chronic insomnia, including those with heart failure (HF). Treatment fidelity evaluation is needed to ensure study validity and reliability. OBJECTIVE: The aim of this study was to apply the National Institutes of Health Behavioral Change Consortium framework to ensure adequate treatment fidelity in a randomized controlled trial of CBT-I for people with stable HF. METHODS: We describe strategies to ensure treatment fidelity in study design, provider training, and treatment delivery. We measured treatment receipt (observation and self-report) and enactment of CBT-I strategies (self-report and actigraphy). We used the Dysfunctional Beliefs and Attitudes About Sleep Scale and the Sleep Disturbance Questionnaire to indicate sleep-related beliefs and cognitions. We computed descriptive statistics for demographic characteristics, treatment receipt, and enactment variables. We compared baseline and post-intervention dichotomous sleep behaviors using the two-sided Wilcoxon rank-sum test. We calculated the root mean square of successive difference in time of sleep onset and midpoint (actigraphy) to indicate day-by-day variability in bed and wake times. RESULTS: Most participants completed the CBT-I intervention and follow-up assessments and attended each group or make-up session. Most correctly computed their sleep efficiency and completed their homework. Most participants used the sleep tracker and reported using strategies to improve their sleep schedules. There was a significant decrease in actigraph-measured light intensity during the 30 minutes and 1 hour before bedtime between baseline and post-intervention and no statistically significant changes in light intensity after waking or in nap frequency. Most of those who woke during the night got out of bed, consistent with recommendations. There were significant improvements on all of the Dysfunctional Beliefs and Attitudes About Sleep items and total score and all but one item on the Sleep Disturbance Questionnaire. DISCUSSION: Preserved treatment fidelity may explain the large and sustained effects in people with HF found in our trial. Further research is needed to evaluate CBT-I's effectiveness and implementation strategies among people with HF in real-world clinical settings.

Sleep Characteristics, Mood, Somatic Symptoms, and Self-Care Among People With Heart Failure and Insomnia.

BACKGROUND: Almost 50% of people with heart failure (HF) experience chronic insomnia and must perform self-care to manage their day-to-day healthcare needs. Understanding multifactorial influences on self-care, including demographic, clinical, and sleep characteristics, and mood and somatic symptoms will help identify people at highest risk for poor self-care. However, past research focused only on the associations of single symptoms and self-care. Multivariate approaches are needed to account for the synergistic associations of self-care with sleep, mood, and somatic symptoms among people with HF. OBJECTIVES: The aims of the study were to (a) evaluate the levels of self-care maintenance and self-care confidence among people with stable HF and chronic insomnia; (b) identify the clinical and demographic correlates of self-care maintenance and confidence among people with stable HF and chronic insomnia; and (c) identify the associations between sleep characteristics, mood and somatic symptoms, and self-care maintenance and confidence among people with stable HF and chronic insomnia. METHODS: We utilized a cross-sectional design with 195 adult participants who had chronic HF and insomnia. We assessed for symptoms of anxiety; depression; dyspnea; fatigue; stress; insomnia severity; and sleep disturbance, impairment, and quality. Self-care was measured using the Self-Care for Heart Failure Index v6.2. We used generalized linear models to test the associations between the demographic and clinical factors and self-care maintenance and confidence; exploratory and confirmatory factor analysis to identify the factor structure underlying the symptoms; and structural equation modeling to test the combined associations of the demographic and clinical factors and latent factors with self-care maintenance and confidence. RESULTS: Self-care maintenance, confidence, and management were inadequate in most participants. We identified three latent factors among the nine symptoms: "sleep characteristics," "mood," and "somatic symptoms." In the structural equation model, "sleep characteristics," White race, and having a left ventricular ejection fraction of <45 were associated with self-care maintenance. Age was negatively associated with self-care confidence. DISCUSSION: Poor sleep characteristics negatively influence the ability of people with HF and insomnia to perform self-care behaviors. Knowledge of the associations among age, left ventricular ejection fraction, and race with self-care will help clinicians and future researchers identify those at risk for poor self-care.

Cognitive behavioral therapy for insomnia has sustained effects on insomnia, fatigue, and function among people with chronic heart failure and insomnia: the HeartSleep Study.

STUDY OBJECTIVES: Insomnia is common among adults with chronic heart failure (HF) and associated with daytime symptoms and decrements in function. The purpose of this randomized controlled trial (RCT) was to evaluate the sustained effects over one year of CBT-I (Healthy Sleep: HS) compared with HF self-management education (Healthy Hearts; attention control: HH) on insomnia severity, sleep characteristics, symptoms, and function among people with stable HF. The primary outcomes were insomnia severity, actigraph-recorded sleep efficiency, and fatigue. METHODS: We randomized adults with stable HF with preserved or reduced ejection fraction who had at least mild insomnia (Insomnia severity index >7) in groups to HS or HH (4 sessions/8 weeks). We obtained wrist actigraphy and measured insomnia severity, self-reported sleep characteristics, symptoms (fatigue, excessive daytime sleepiness, anxiety, depression), and six-minute walk distance at baseline, within one month of treatment, and at 6 and 12 months. We used general linear mixed models (GLMM) and generalized estimating equations (GEE) to evaluate the effects. RESULTS: The sample included 175 participants (M age = 63 ± 12.9 years; 43% women; 18% Black; 68% New York Heart Association Class II or II; 33%; LVEF < 45%) randomized to HS (n = 91) or HH (n = 84). HS had sustained effects on insomnia severity, sleep quality, self-reported sleep latency and efficiency, fatigue, excessive daytime sleepiness, and six-minute walk distance at 12 months. CONCLUSIONS: CBT-I produced sustained improvements in insomnia, fatigue, daytime sleepiness, and objectively measured physical function among adults with chronic HF, compared with a robust HF self-management program that included sleep hygiene education. CLINICAL TRIAL INFORMATION: Insomnia Self-Management in Heart Failure; https://clinicaltrials.gov/ct2/show/NCT02660385; NCT02660385.