Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF):Study protocol for a randomized controlled trial

BACKGROUND: Frequent rehospitalisations and poorer survival chances in heart failure (HF) patients may partly be explained by poor medication adherence. There are multiple medication-related reasons for suboptimal adherence, but psychological reasons may also be important. A novel TELEmonitoring device may improve MEDication adherence in HF patients (TELEMED-HF). TELEMED-HF is a randomized, controlled clinical intervention trial designed to examine (1) the efficacy and cost-efficiency of an electronic medication adherence support system in improving and monitoring HF patients' medication adherence; (2) the effect of medication adherence on hospitalizations and health care consumption; as well as on (3) clinical characteristics, and Quality of Life (QoL); and (4) clinical, sociodemographic, and psychological determinants of medication adherence. METHODS/DESIGN: Consecutive patients with chronic, systolic HF presenting to the outpatient clinic of the TweeSteden Hospital, The Netherlands, will be approached for study participation and randomly assigned (1:1) following blocked randomization procedures to the intervention (n = 200) or usual care arm (n = 200). Patients in the intervention arm use the medication support device for six months in addition to usual care. Post-intervention, patients return to usual care only and all patients participate in four follow-up occasions over 12 months. Primary endpoints comprise objective and subjective medication adherence, healthcare consumption, number of hospitalizations, and cost-effectiveness. Secondary endpoints include disease severity, physical functioning, and QoL. DISCUSSION: The TELEMED-HF study will provide us a comprehensive understanding of medication adherence in HF patients, and will show whether telemonitoring is effective and cost-efficient in improving adherence and preventing hospitalization in HF patients. TRIAL REGISTRATION NUMBER: NCT01347528

Self-care and all-cause mortality in patients with chronic heart failure

Objectives This study examined the association of self-care with all-cause mortality in a cohort of patients with chronic heart failure (HF). Background Although self-care is crucial to maintain health in patients with chronic HF, studies examining an association with clinical outcomes are scarce. Methods Consecutive patients with chronic HF (n = 559, mean age 66.3 ± 9.5 years, 78% men) completed the 9-item European Heart Failure Self-care Behaviour scale. Our endpoint was all-cause mortality. Associations between self-care and all-cause mortality were assessed with Kaplan-Meier analyses and multivariable Cox regression accounting for standard sociodemographic and clinical covariates, psychological distress, and self-rated health. Results After a median follow-up of 5.5 ± 2.4 years (range 16 weeks to 9.9 years), 221 deaths (40%) from any cause were recorded. There was no evidence of a mortality benefit in patients high over those low in global self-care (p = 0.71). In post hoc analyses, low self-reported sodium intake was associated with increased mortality (adjusted hazard ratio: 1.47; 95% confidence interval: 1.10 to 1.96; p = 0.01). Other significant predictors of mortality were: male sex, lack of a partner, New York Heart Association functional class III to IV, and increasing comorbid conditions. Conclusions Global self-care was not associated with long-term mortality whereas low self-reported sodium intake independently predicted increased all-cause mortality beyond parameters of disease severity. Replication of findings is needed as well as studies examining the correspondence of subjectively and objectively measured sodium intake and its effects on long-term prognosis in patients with chronic HF. Key Words heart failure, mortality, self-care, sodium intake, surviva

Self care and health related quality of life in chronic heart failure: A longitudinal analysis

Background: Self-care is assumed to benefit health outcomes in patients with chronic heart failure (HF), but the evidence is conflicting for health-related quality of life (HRQOL). The aim of this study was to examine the association of (changes in) self-care with HRQOL while adjusting for psychological distress. Methods: In total, 459 patients (mean age = 66.1 ± 10.5 years, 73% male) with chronic HF completed questionnaires at baseline and at 6, 12 and 18 months of follow-up. Self-care and HF-specific HRQOL were quantified with the European Heart Failure Self-care Behaviour scale and the Minnesota Living with Heart Failure Questionnaire.Results:Using general linear models, multivariable between-subject (estimate = –0.14, p = 0.005) and no within-subject effects of self-care were found for better HRQOL over time. Associations between self-care and HRQOL were fully explained by depression (estimate = 1.77, p < 0.001). Anxiety (estimate = 4.49, p < 0.001) and Type D personality (estimate = 13.3, p < 0.001) were associated with poor HRQOL, but only partially accounted for the relationship between self-care and emotional HRQOL. Conclusions: Self-care was prospectively associated with better disease-specific HRQOL in patients with HF, which was fully accounted for by depression, and partially accounted for by anxiety and Type D personality. Changes in self-care within a person did not affect HRQOL. Psychological distress should be considered in future efforts to address self-care and HRQOL

Psychological determinants of heart failure self-care: Systematic review and meta-analysis

Objective:  Psychological distress has been associated with poor outcomes in patients with chronic heart failure (HF), which is assumed to be partly due to poor HF self-care behavior. This systematic review and meta-analysis describes the current evidence concerning psychological determinants of self-care in patients with chronic HF. Methods:  Eligible studies were systematically identified by searching electronic databases PubMed, PsycINFO, and the Conference Proceedings Citation Index (Web of Science) for relevant literature (1980–October 17, 2014). Study quality was assessed according to the level of risk of bias. Quantitative data were pooled using random-effects models. Results:  Sixty-five studies were identified for inclusion that varied considerably with respect to sample and study characteristics. Risk of bias was high in the reviewed studies and most problematic with regard to selection bias (67%). Depression (r = −0.19, p < .001), self-efficacy (r = 0.37, p < .001), and mental well-being (r = 0.14, p = .030) were significantly associated with self-reported self-care. Anxiety was not significantly associated with either self-reported (r = −0.18, p = .24) or objective self-care (r = −0.04, p = .79), neither was depression associated with objectively measured medication adherence (r = −0.05, p = .44). Conclusions:  Psychological factors (depression, self-efficacy, and mental well-being) were associated with specific self-care facets in patients with chronic HF. These associations were predominantly observed with self-reported indices of self-care and not objective indices. Methodological heterogeneity and limitations preclude definite conclusions about the association between psychological factors and self-care and should be addressed in future research

Fatigue and self-care in patients with chronic heart failure

Background: Fatigue is a debilitating and highly prevalent symptom in patients with chronic heart failure (HF) possibly complicating HF self-care behaviour which is crucial for maintaining health. Aims: The purpose of this study was to examine whether general and exertion fatigue are distinctively associated with self-care in patients with chronic HF. Methods: In total, 545 outpatients with chronic HF (mean age=66.2 years; 75% male) completed measures of general fatigue (i.e. a sustained sense of exhaustion including mental efforts), exertion fatigue (i.e. fatigue directly related to physical activity), sleep problems, mood symptoms and HF self-care behaviour at baseline, 12-, and 18-month follow-up. Results: Linear mixed modelling results showed that general and exertion fatigue were significantly associated with poor HF self-care (estimate=0.10, p=0.004; estimate=0.06, p=0.01, respectively) and poor consulting behaviour (estimate=0.05, p=0.04; estimate=0.04, p=0.007, respectively) over time, independent of sleep and mood problems, and other clinical covariates. Exertion fatigue was associated with supplementary determinants. Conclusion: This is the first prospective study demonstrating that general and exertion fatigue were both associated with poor HF self-care, which could not be explained by sleep problems or mood symptoms, and was independent of clinical indicators of disease severity. Treatment of fatigue problems may improve HF self-care skills and ultimately quality of life and cardiovascular outcomes. Further research is needed to examine this potential causal relationship

How are depression and Type D Personality associated with outcomes in chronic heart failure patients?

This review aims to summarize the current evidence for the association of depression and Type D personality with clinical and patient-centred outcomes and self-care in chronic heart failure (CHF) patients. Emotional distress is highly prevalent in CHF patients. In contrast to results in coronary artery disease, there is inconsistent evidence for the adverse effects of depression and Type D on prognosis. Type D and depression are important predictors of impaired health status in CHF, and patients characterised by depression or Type D report reduced self-care. Pathophysiological processes associated with depression and Type D are discussed, as they may contribute to disease progression. Future research may benefit from taking inconsistencies in and problems with assessment of depression and Type D into account, as well as focusing on the network of psychophysiological and behavioural factors to elucidate their precise role in CHF patients with depression or Type D. Furthermore, it is advised that clinicians address the observed differences in self-care behaviours to improve health in CHF patients with depression or Type D personality. Keywords: Depression, Type D personality, Chronic heart failure, Medical outcomes, Patient reported outcomes, Behavioural, Biological, Mechanisms, Mortality, Review, Emotional distress, Health status, Self-care, Psychobiologica