Perceived Control, Functional Status, Depressive Symptoms, and Anxiety: Mediating and Moderating Influences on Health-Related Quality of Life in Patients With Heart Failure.

BACKGROUND: Health-related quality of life (HRQoL) is poor in patients with heart failure. Psychological (ie, depressive symptoms [DS], anxiety, and perceived control) and physical (ie, functional status) factors are associated with HRQoL. The dynamic relationships among these variables and their impact on HRQoL remain unclear, limiting the ability to design effective interventions. PURPOSE: Our aim was to evaluate a moderated mediation model, in which the association between perceived control and HRQoL was hypothesized to be mediated by DS and anxiety in the presence of a moderator, functional status. METHODS: Patients (N = 426) with heart failure completed the Control Attitudes Scale-Revised to measure perceived control, Duke Activity Status Index for functional status, Patient Health Questionnaire-9 for DS, Brief Symptom Inventory for anxiety, and Minnesota Living with Heart Failure Questionnaire for HRQoL. We performed a moderated parallel mediation analysis. RESULTS: Higher levels of perceived control were associated with better HRQoL through lower levels of anxiety and DS in the presence of functional status (index of moderated mediation for DS, b = 0.029; 95% confidence interval, 0.016-0.045; for anxiety: b = 0.009, 95% confidence interval, 0.002-0.018). The effect of perceived control on psychological symptoms was stronger at low and moderate functional statuses; however, this effect diminished with increasing functional status. CONCLUSION: Functional status moderated the indirect effects of perceived control on HRQoL through DS and anxiety in patients with heart failure. Efforts to improve HRQoL by targeting perceived control may be more effective when considering DS and anxiety in patients with low to moderate levels of functional status.

Mediation by Fatalism of the Association Between Symptom Burden and Self-care Management in Patients With Heart Failure.

BACKGROUND: Clinicians and researchers often assume that symptom burden is associated with self-care management (SCM) in patients with heart failure (HF). However, that association is often not borne out in simple regression analyses and may be because another variable mediates the association. Fatalism is an appropriate candidate for mediation and is the belief that circumstances are predetermined without opportunity for control by individuals. OBJECTIVE: Our objective was to determine whether fatalism mediated the relationship of symptom burden with SCM among adults with HF. METHODS: We conducted a secondary analysis (N = 95) from a clinical trial. We used Self-care of HF Index to measure SCM, the Memorial Symptom Assessment Scale-HF for symptom burden, and the Cardiovascular Disease Fatalism Instrument to measure fatalism. We used the PROCESS macro to evaluate mediation. RESULTS: Symptom burden was not directly associated with SCM (effect coefficient [C'] = 0.0805; 95% confidence interval, -0.048 to 0.209; P = .217). There was, however, an indirect pathway between symptom burden and SCM through fatalism (ab = -0.040; 95% confidence interval, -0.097 to -0.002). Those with higher symptom burden were more fatalistic (a = 0.004, P = .015), and greater fatalism was associated with worse SCM (b = -9.132, P = .007). CONCLUSION: Symptom burden, not directly associated with SCM, is associated through the mediator of fatalism. Interventions to improve SCM should include strategies to mitigate fatalistic views. Self-care management interventions should focus on promoting internal locus of control or increasing perceptions of perceived control to decrease fatalism and improve engagement in self-care.

Psychometric Testing of the Control Attitudes Scale-Revised for Patients With a Left Ventricular Assist Device.

BACKGROUND: Perceived control, an indicator of the patient's ability to cope and thrive with a chronic illness, is a common target of nursing interventions. As of 2019, more than 25 000 patients had been implanted with a left ventricular assist device (LVAD) as a treatment of advanced heart failure. Patients with an LVAD experience significant life changes that affect anxiety, depression, health-related quality of life, and, presumably, perceived control. To adequately intervene and improve perceived control, a reliable and valid measure is needed. OBJECTIVES: The objectives of this analysis were to (1) assess item discrimination and anticipated range of scores of the Control Attitudes Scale-Revised (CAS-R), (2) assess the internal consistency and validity of the CAS-R, and (3) examine perceived control in a sample of patients with an LVAD. METHODS: Two cohorts of patients with an LVAD (n = 113) were combined to evaluate the psychometric qualities of the CAS-R. Correlations among patient-reported outcomes and perceived control were used to evaluate validity. Cronbach α was used to test internal consistency. Item response theory was used to measure item discrimination and anticipated scores. Descriptive statistics describe perceived control in the sample. RESULTS: Overall, the CAS-R demonstrated good internal consistency and convergent validity with other patient-reported outcomes. Using the item response theory, we saw that the CAS-R was a good predictor of lower-moderate scorers but was not good at differentiating high performers. There were several items that were poor discriminators and could be altered or discarded to create a more predictive instrument. CONCLUSIONS: The CAS-R is a valid and reliable instrument to measure perceived control in patients who have LVAD implants; however, more work could be done to improve item-level information.

The effectiveness of self-care interventions in chronic illness: A meta-analysis of randomized controlled trials.

OBJECTIVE: To characterize and explain variation in the comparative effectiveness of self-care interventions on relevant outcomes of chronic illness compared with controls. DESIGN: Meta-analysis and meta-regression. METHODS: Data extraction was framed within the context of a previously-published scoping review of randomized trials designed to enhance self-care in type 2 diabetes mellitus, heart failure, hypertension, asthma, coronary artery disease, and chronic obstructive pulmonary disease (published between 2008 and 2019). Data were pooled using random-effects meta-analyses. Meta-regression was used to test the effect of potential moderators on trial effectiveness. RESULTS: 145 trials involving 36,853 participants were included. Overall, the effect size of self-care interventions on improving outcomes was small (Hedges' g = 0.29 (95% CI = 0.25-0.33), p < 0.001) with statistically significant heterogeneity across trials (Q = 514.85, p < 0.001, I2 = 72.0%). A majority of trials (n = 83, 57.2%) were rated as having a high risk of bias. There was no statistically significant difference in trial effectiveness based on the use of theory, specific components of self-care addressed, the number of modes of delivery, the number of behavioral change techniques, specific modes of delivery, specific behavioral change techniques, intervention duration, total number of hours of intervention, or either participant age or gender. CONCLUSIONS: Self-care interventions are modestly effective in improving outcomes. Poor trial quality limits the strength of conclusions in this area of science. There is much to be done to enhance the design, conduct and reporting of self-care trials in order to gain more insight into the effectiveness of self-care interventions. TWEETABLE ABSTRACT: New review highlights poor trial design as major impediment to understanding the contribution of self -care to outcomes in chronic illness.

Patterns and predictors of dyspnoea following left ventricular assist device implantation.

AIMS: Dyspnoea is a common symptom of heart failure (HF) that often prompts patients to seek treatment. Implantation of a left ventricular assist device (LVAD) has been associated with reduced dyspnoea but it is unclear if all patients experience similar improvements in dyspnoea over time following LVAD implantation. Our aim was to identify distinct trajectories of dyspnoea symptoms over time following LVAD implantation and predictors of dyspnoea trajectory. We hypothesized that at least two, distinct trajectories of dyspnoea would be observed following LVAD implantation. METHODS AND RESULTS: This was a secondary analysis of data from the Profiling Biobehavioral Responses to Mechanical Support in Advanced Heart Failure study. In the parent study, sociodemographic and clinical data were collected prior to LVAD implantation and at 1, 3, and 6 months following LVAD implantation from a sample (n = 101) of patients with advanced HF. Latent growth mixture modelling was performed to identify distinct trajectories of dyspnoea symptoms. Backwards stepwise logistic regression was used to identify predictors of dyspnoea trajectory. Two, distinct trajectories of dyspnoea symptoms were identified: sustained improvement and unsustained improvement. Participants who experienced sustained improvement (86.7% of sample) demonstrated large, significant improvement in dyspnoea from pre-implantation to 3 months post-implant followed by smaller, non-significant improvement from 3 to 6 months. Participants who experienced unsustained improvement (13.3% of sample) demonstrated initial improvement from pre-implantation to 3 months post-implantation followed by worsening of dyspnoea from 3 to 6 months. Greater depressive symptoms at baseline and living alone were significant predictors of unsustained improvement. CONCLUSION: Patients experience different patterns of dyspnoea over time following LVAD implantation. Clinicians should inquire about living arrangements and depressive symptoms at each visit to determine risk of unsustained improvement in dyspnoea.

A Multibiomarker Latent Class Analysis in Moderate to Advanced Heart Failure: Differentiating Factors.

BACKGROUND: Biomarker science in heart failure (HF) is advancing quickly in our ability to diagnosis and treat patients with this complex syndrome. Researchers are urged to not use single-marker strategies, but instead evaluate biomarkers in patterns to better understand their relationship to one another, as well as disease progression. Latent class mixture modeling allows researchers to determine novel associations between biomarkers. OBJECTIVE: The objectives of this study were to identify and compare latent classes of cardiovascular biomarkers among patients with moderate to advanced HF. METHODS: This was a cross-sectional study of 96 participants with moderate to advanced HF. Latent class mixture modeling was used to identify unique classes of biomarkers and their associations to sociodemographic and clinical variables. RESULTS: The average age of the sample was 54 years, with most of the sample being men (77%) and having an average ejection fraction of 23%. Two unique classes of biomarkers were identified. Latent class 1 had higher levels of all biomarkers, whereas latent class 2 had lower levels. The higher biomarker class had, on average, more neurohormonal activation and fluid retention; however, the higher levels of biomarker class were not more likely to be diagnosed with advanced HF or have more comorbidities. CONCLUSION: By identifying classes of biomarkers, providers may be better able to identify patients who are at risk of progressing into advanced HF quicker or those who are more likely to have more severe complications, such as fluid overload or renal disease.

Adverse events in patients with a left ventricular assist device: are patient-reported outcomes affected?

AIMS: Left ventricular assist devices (LVAD) are used to treat advanced heart failure, and the use of these devices in ever increasing, with over 19 000 people having had a device. However, during device therapy over 50% of patients will have some type of major adverse event. The aim of this study was to examine whether having a major adverse event, including major infection and major bleed, would alter patient-reported outcomes over time, including depressive symptoms and health-related quality of life. METHODS AND RESULTS: T-tests and χ2 analyses were used to determine significant differences between patients who had an adverse event and those who did not. Latent curve growth modelling was used to evaluate change over time in those patients with and without and adverse event. The only difference between those with and without an adverse event was pre-implant depressive symptoms and health-related quality of life. The trajectories of both groups were also similar, with only differences at the pre-implant time point. CONCLUSION: In response to an adverse event occurring post-LVAD implantation, we found that patient-reported outcomes, including depressive symptoms and health-related quality of life were not significantly impacted.

Patterns of Heart Failure Dyadic Illness Management: The Important Role of Gender.

BACKGROUND: The ways in which patients with heart failure (HF) and their care partners work together to manage HF are often overlooked. OBJECTIVE: The aim of this study was to identify and compare different patterns of HF dyadic illness management. METHODS: This was a secondary analysis of data on HF dyads. Heart failure management was measured using patient and care partner versions of the Self-Care of HF Index and European HF Self-care Behavior Scale. Latent class modeling was used to identify patterns of HF dyadic management. RESULTS: The mean age of the 62 patients and their care partners was 59.7 ± 11.8 and 58.1 ± 11.9 years, respectively. A majority of patients (71.0%) had class III/IV HF, and a majority of the couples (95.2%) were married. Two distinct dyadic patterns were observed, 1 collaborative management type (n = 42, 67.7%) and 1 autonomous management type (n = 20, 32.3%). Dyads in the autonomous pattern were mostly female patients with male care partners; patients in this pattern also were more anxious and depressed, and reported worse relationship quality compared with collaborative dyads. CONCLUSION: There is an engendered spectrum of collaboration in how HF patient-care partner dyads work together to manage HF that needs to be considered in clinical care and research.

Experiences with end-of-life care with a left ventricular assist device: An integrative review.

Left ventricular assist devices (LVAD) are increasingly being used to treat end-stage heart failure. Despite the increased prevalence of these devices, there is a still a high 1-year mortality rate. The purpose of this integrative review was to systematically evaluate research studies that focused on the process and content of LVAD related end-of-life discussions. A literature search was conducted from earliest available date to November, 2017. A total of 59 citations were produced, 13 articles went under full review, and six studies remained for inclusion in this review. Patients and their caregivers experienced confusion and frustration regarding the end-of-life experiences and care related to disjointed care by their provider teams. Clinician experiences and opinions also suggested a controversy about deactivation of the LVAD at the end-of-life, and a divide regarding practices at the end-of-life. Research focused on system-level factors involved in end-of-life care for patients with an LVAD is needed.

Shared Decision-Making About End-of-Life Care Scenarios Compared Among Implantable Cardioverter Defibrillator Patients: A National Cohort Study.

BACKGROUND: Authors of expert guidelines and consensus statements recommend that decisions at the end-of-life (EOL) be discussed before and after implantation of an implantable cardioverter defibrillator (ICD) and include promotion of shared decision-making. The purpose of this study was to describe experiences, attitudes, and knowledge about the ICD at EOL in ICD recipients and to compare experiences, attitudes, and knowledge in ICD recipients with and without heart failure (HF). We further sought to determine factors associated with having discussions about EOL. METHODS AND RESULTS: Using a national registry in Sweden of all ICD recipients (n=5355) in 2012, an EOL questionnaire, along with other ICD-related measures, was completed by 2403 ICD recipients. Of the participants, 1275 (n=53%) had HF. Their responses in the knowledge, experience, and attitude domains were almost identical to those without HF. Forty percent of patients with and without HF did not want to discuss their illness trajectory or deactivation of their ICD ever. In logistic regression analyses, we found that having had an ICD shock (OR, 2.05; CI, 1.64-2.56), having high levels of anxiety (OR, 1.41; CI, 1.04-1.92), and having high levels of ICD concerns (OR, 1.53; CI, 1.22-1.92) were the only significant predictors of having discussions with providers about EOL scenarios (P<0.001 for full model). CONCLUSIONS: HF was not a predictor of having an EOL conversation. Further research is needed to determine if attitudes related to not wanting to discuss EOL interfere with good quality of life and of death, or if shared decision-making should be encouraged in these individuals.