The Effectiveness of a Motivational Interviewing Intervention on Mutuality Between Patients With Heart Failure and Their Caregivers: A Secondary Outcome Analysis of the MOTIVATE-HF Randomized Controlled Trial.

BACKGROUND: Mutuality, defined as "the positive quality of the relationship between a caregiver and a care receiver", was found to be associated with self-care and caregiver contribution to self-care in heart failure (HF). However, no studies were conducted to evaluate whether motivational interviewing (MI) can improve mutuality in patients with HF and caregivers. OBJECTIVES: The aim of this study was to evaluate the effectiveness of MI on mutuality in HF patient-caregiver dyads. METHODS: This is a secondary outcome analysis of the MOTIVATE-HF randomized controlled trial, the primary aim of which was to evaluate the effect of MI on improving self-care in patients with HF. Participants were randomized into 3 arms: (1) MI for patients only, (2) MI for both patients and caregivers, and (3) standard care. To assess the HF patients' and caregivers' mutuality, the Mutuality Scale was used in its patient and caregiver versions. RESULTS: Patients with HF had a median age of 74 years, and there were more men (58%). Most patients were retired (76.2%). Caregivers had a median age of 55 years and were mostly women (75.5%). Most patients were in New York Heart Association class II (61.9%) and had an ischemic HF etiology (33.6%). The motivational interviews did not show any impact on changes in the patient and caregiver mutuality during the follow-up time (3, 6, 9, and 12 months from baseline). The condition of living together between the patient and the caregiver was significantly associated with better mutuality between the patient and the caregiver. CONCLUSIONS: Motivational interviewing performed by nurses was not effective in improving mutuality in patients with HF and caregivers, but the target variable of the intervention was patient self-care. Stronger effects of MI on mutuality were observed in patients with HF and caregivers who live together. Future studies should target mutuality to see whether MI is really effective.

Elevated Serum Urea-to-Creatinine Ratio and In-Hospital Death in Patients with Hyponatremia Hospitalized for COVID-19.

Hyponatremia is associated with adverse outcomes in hospitalized patients. An elevated value of the serum urea-to-creatinine ratio (UCR) has been proposed as a proxy of hypovolemia. The aim of this study was to investigate the relationship between the UCR and in-hospital death in patients hospitalized with COVID-19 and hyponatremia. We studied 258 patients admitted for COVID-19 between January 2020 and May 2021 with serum sodium at < 135 mmol/L. The primary end-point was all-cause mortality. A 5-unit increase in the serum UCR during hospital stays was associated with an 8% increase in the hazard of all-cause death (HR = 1.08, 95% CI: 1.03-1.14, p = 0.001) after adjusting for potential confounders. In patients with a UCR > 40 at baseline, a > 10 mmol/L increase in serum sodium values within the first week of hospitalization was associated with higher odds of in-hospital death (OR = 2.93, 95% CI: 1.03-8.36, p = 0.044) compared to patients who experienced a < 10 mmol/L change. This was not observed in patients with a UCR < 40. Hypovolemia developing during hospital stays in COVID-19 patients with hyponatremia detected at hospital admission bears an adverse prognostic impact. Moreover, in hypovolemic patients, a > 10 mmol/L increase in serum sodium within the first week of hospital stays may further worsen the in-hospital prognosis.

The Impact of an Intervention to Improve Caregiver Contribution to Heart Failure Self-care on Caregiver Anxiety, Depression, Quality of Life, and Sleep.

BACKGROUND: Better caregiver contribution to self-care in heart failure is associated with better patient outcomes. However, caregiver contribution to self-care is also associated with high anxiety and depression, poor quality of life, and poor sleep in caregivers. It is still unclear whether interventions that encourage caregivers to contribute more to patient self-care might increase caregivers' anxiety and depression and decrease their quality of life and sleep. OBJECTIVE: The aim of this study was to assess the impact of a motivational interview intervention aimed at improving caregiver contribution to self-care in heart failure on caregivers' anxiety, depression, quality of life, and sleep. METHODS: This is a secondary outcome analysis of the MOTIVATE-HF trial. Patients with heart failure and their caregivers were randomized into arm 1 (motivational interview to patients), arm 2 (motivational interview to patients and caregivers), and arm 3 (standard care). Data were collected between June 2014 and October 2018. The article has been prepared following the Consolidated Standards of Reporting Trials checklist. RESULTS: A sample of 510 patient-caregiver dyads was enrolled. Over the year of the study, the levels of anxiety, depression, quality of life, and sleep in caregivers did not significantly change among the 3 arms. CONCLUSIONS: Motivational interview aimed at improving caregiver contribution to self-care does not seem to increase caregiver anxiety and depression, nor decrease their quality of life and sleep. Thus, such an intervention might be safely delivered to caregivers of patients with heart failure, although further studies are needed to confirm our findings.

Development and validation of an electronic database-based frailty index to predict mortality and hospitalization in a population-based study of adults with SARS-CoV-2.

Background: Electronic health databases are used to identify people at risk of poor outcomes. Using electronic regional health databases (e-RHD), we aimed to develop and validate a frailty index (FI), compare it with a clinically based FI, and assess its association with health outcomes in community-dwellers with SARS-CoV-2. Methods: Data retrieved from the Lombardy e-RHD were used to develop a 40-item FI (e-RHD-FI) in adults (i.e., aged ≥18 years) with a positive nasopharyngeal swab polymerase chain reaction test for SARS-CoV-2 by May 20, 2021. The considered deficits referred to the health status before SARS-CoV-2. The e-RHD-FI was validated against a clinically based FI (c-FI) obtained from a cohort of people hospitalized with COVID-19 and in-hospital mortality was evaluated. e-RHD-FI performance was evaluated to predict 30-day mortality, hospitalization, and 60-day COVID-19 WHO clinical progression scale, in Regional Health System beneficiaries with SARS-CoV-2. Results: We calculated the e-RHD-FI in 689,197 adults (51.9% females, median age 52 years). On the clinical cohort, e-RHD-FI correlated with c-FI and was significantly associated with in-hospital mortality. In a multivariable Cox model, adjusted for confounders, each 0.1-point increment of e-RHD-FI was associated with increased 30-day mortality (Hazard Ratio, HR 1.45, 99% Confidence Intervals, CI: 1.42-1.47), 30-day hospitalization (HR per 0.1-point increment = 1.47, 99%CI: 1.46-1.49), and WHO clinical progression scale (Odds Ratio = 1.84 of deteriorating by one category, 99%CI 1.80-1.87). Conclusion: The e-RHD-FI can predict 30-day mortality, 30-day hospitalization, and WHO clinical progression scale in a large population of community-dwellers with SARS-CoV-2 test positivity. Our findings support the need to assess frailty with e-RHD.

Negative prognostic impact of electrolyte disorders in patients hospitalized for Covid-19 in a large multicenter study.

BACKGROUND: The prognostic impact of electrolyte disorders in hospitalized COVID-19 patients is unclear. METHODS: The study included all adult patients hospitalized for COVID-19 in four hospitals in Northern Italy between January 2020 and May 2021 with at least one serum potassium and sodium measurement performed within 3 days since admission. Primary outcome was in-hospital death; secondary outcome was Intensive Care Unit (ICU) admission. A cause-specific Cox proportional-hazards regression model was used for investigating the association between potassium and sodium (as either categorical or continuous variables) and mortality or admission to ICU. RESULTS: Analyses included 3,418 adult hospitalized COVID-19 patients. At multivariable analysis, both hyperkalemia (Hazard Ratio, [HR] 1.833, 95% Confidence Interval [CI] 1.371-2.450) and sK above the median (K 5.1 vs 4.1 mmol/L: HR 1.523, 95% CI 1.295-1.798), and hypernatremia (HR 2.313, 95%CI 1.772-3.018) and sNa above the median (Na 149 vs 139 mmol/L: HR 1.442, 95% CI 1.234-1.686), were associated with in-hospital death, whereas hypokalemia and hyponatremia were not. Hyponatremia was associated with increased hazard of ICU admission (HR 1.884, 95%CI 1.389-2.556). CONCLUSIONS: Electrolyte disorders detected at hospital admission may allow early identification of COVID-19 patients at increased risk of adverse outcomes.

Incident Atrial Fibrillation and In-Hospital Mortality in SARS-CoV-2 Patients.

(1) Background: Among the different cardiovascular (CV) manifestations of the coronavirus disease 2019 (COVID-19), arrhythmia and atrial fibrillation (AF) in particular have recently received special attention. The aims of our study were to estimate the incidence of AF in patients hospitalized for COVID-19, and to evaluate its role as a possible predictor of in-hospital all-cause mortality. (2) Methods: We enrolled 3435 people with SARS-CoV2 infection admitted to three hospitals in Northern Italy from February 2020 to May 2021. We collected data on their clinical history, laboratory tests, pharmacological treatment and intensive care unit (ICU) admission. Incident AF and all-cause in-hospital mortality were considered as outcomes. (3) Results: 145 (4.2%) patients developed AF during hospitalization, with a median time since admission of 3 days (I-III quartile: 0, 12). Patients with incident AF were admitted more frequently to the ICU (39.3 vs. 12.4%, p < 0.001), and more frequently died (37.2 vs. 16.9%, p < 0.001). In the Cox regression model, the significant determinants of incident AF were age (HR: 1.041; 95% CI: 1.022, 1.060 per year), a history of AF (HR: 2.720; 95% CI: 1.508, 4.907), lymphocyte count (HR: 0.584; 95% CI: 0.384, 0.888 per 103/µL), estimated glomerular filtration rate (eGFR, HR: 0.988; 95% CI: 0.980, 0.996 per mL/min) and ICU admission (HR: 5.311; 95% CI: 3.397, 8.302). Incident AF was a predictor of all-cause mortality (HR: 1.405; 95% CI: 1.027, 1.992) along with age (HR: 1.057; 95% CI: 1.047, 1.067), male gender (HR: 1.315; 95% CI: 1.064; 1.626), dementia (HR: 1.373; 95% CI: 1.045, 1.803), lower platelet (HR: 0.997; 95% CI: 0.996, 0.998 per 103/µL) and lymphocyte counts (HR: 0.843; 95% CI: 0.725, 0.982 per 103/µL), C-Reactive protein values (HR: 1.004; 95% CI: 1.003, 1.005 per mg/L), eGFR (HR: 0.990; 95% CI: 0.986, 0.994 per mL/min), and ICU admission (HR: 1.759; 95% CI: 1.292, 2.395). (4) Conclusions: Incident AF is a common complication in COVID-19 patients during hospitalization, and its occurrence strongly predicts in-hospital mortality.

Effectiveness of Motivational Interviewing on contribution to self-care, self-efficacy, and preparedness in caregivers of patients with heart failure: a secondary outcome analysis of the MOTIVATE-HF randomized controlled trial.

AIMS: Caregiver characteristics and behaviours are associated with patients' and caregivers' outcomes. However, there is scarce evidence on interventions aimed at improving caregiver contribution (CC) to patient self-care, caregiver self-efficacy, and caregiver preparedness in heart failure (HF). This study aims to evaluate the effect of Motivational Interviewing (MI) on CC to patient self-care, caregiver self-efficacy, and caregiver preparedness in HF. METHODS AND RESULTS: This is a secondary outcome analysis of MOTIVATE-HF randomized controlled trial. Caregivers of patients with HF were randomized into three arms: Arm 1 (MI for patients), Arm 2 (MI for patients and caregivers), and Arm 3 (standard care). The intervention consisted of one MI session plus three telephone contacts. Data were collected at baseline and after 3, 6, 9, and 12 months. A total of 510 patient and caregiver (median age 54 years, 76% females) dyads were enrolled, 235 caregivers and 238 patients completed the study until 12 months. Caregiver contribution to self-care maintenance and management and caregiver preparedness significantly improved over time, but without significant differences among the three arms. At 9 months, caregiver self-efficacy improved more in Arm 2 than Arm 3 [difference: 8.36, 95% confidence interval (CI) (3.13; 13.59), P = 0.001]. This improvement remained significant also at linear mixed model [ß^ = 1.39, 95% CI (0.02; 2.75), P = 0.046]. CONCLUSION: Motivational Interviewing did not improve CC to patient self-care and caregiver preparedness. However, it increased caregiver self-efficacy, which is known to be a powerful mediator of CC to self-care. REGISTRATION: Clinicaltrials.gov: NCT02894502.

Uric acid associated with acute heart failure presentation in Acute Coronary Syndrome patients.

We focused on the role of Uric Acid (UA) as a possible determinant of Heart Failure (HF) related issues in Acute Coronary Syndromes (ACS) patients. Main outcomes were acute HF and cardiogenic shock at admission, secondary outcomes were the use of Non Invasive Ventilation (NIV) and the admission Left Ventricular Ejection Fraction (LVEF). We consecutively enrolled 1269 ACS patients admitted to the cardiological Intensive Care Unit of the Niguarda and San Paolo hospitals (Milan, Italy) from June 2016 to June 2019. Median age was 68 (first-third quartile 59-77) years and males were 970 (76%). All the evaluated outcomes occurred more frequently in the hyperuricemic subjects (UA higher than 6 mg/dL for females and 7 mg/dL for males, n = 292): acute HF 35.8 vs 11.1% (p < 0.0001), cardiogenic shock 10 vs 3.1% (p < 0.0001), NIV 24.1 vs 5.1% (p < 0.0001) and lower admission LVEF (42.9±12.8 vs 49.6±9.9, p < 0.0001). By multivariable analyses, UA was confirmed to be significantly associated with all the outcomes with the following Odds Ratio (OR): acute HF OR = 1.119; 95% CI 1.019;1.229; cardiogenic shock OR = 1.157; 95% CI 1.001;1.337; NIV use OR = 1.208; 95% CI 1.078;1.354; LVEF ß = -0.999; 95% CI -1.413;-0.586. We found a significant association between UA and acute HF, cardiogenic shock, NIV use and LVEF. Due to the cross-sectional nature of our study no definite answer on the direction of these relationship can be drawn and further longitudinal study on UA changes over time during an ACS hospitalization are needed.

A Motivational Interviewing Intervention Improves Physical Symptoms in Patients with Heart Failure: A Secondary Outcome Analysis of the Motivate-HF Randomized Controlled Trial.

CONTEXT: Heart failure (HF) patients experience high burden of physical symptoms during their disease trajectory. OBJECTIVE: To evaluate the effects of Motivational Interviewing (MI) on the burden of physical symptoms in HF patients. METHODS: We performed a secondary analysis of data from the MOTIVATE-HF randomized controlled trial. A sample of 510 patients (median 74 years, 58% male) and their caregivers (median 55 years, 75.5% female) was randomly allocated to Arm 1 (MI only for patients), Arm 2 (MI for patients and caregivers), and Arm 3 (standard of care). The MI intervention consisted of one face-to-face session plus three telephone calls conducted within two months from enrollment. Symptoms' burden was assessed with the Heart Failure Somatic Perception Scale (HFSPS) with the dimensions of Chest Discomfort, Dyspnea, Early and subtle and Edema. Data were collected at baseline and at 3, 6, 9, and 12 months after enrollment. RESULTS: At 12 months, Chest Discomfort improved in Arms 1 and 2 vs Arm 3 (Δ: -8.13, 95% CI: -14.61; -1.65). Dyspnea improved in Arms 1 and 2 vs Arm 3 both at 9 and 12 months (Δ: -7, 95% CI: -13.18; -0.82 and -6.78, 95% CI: -13.19; -0.38); HFSPS total score improved in Arm 1 and Arm 2 vs Arm 3 at 9 months (Δ: -4.55, 95% CI: -9.05; -0.05). Over 1 year, Chest Discomfort and HFSPS total score in Arm 2 improved compared to Arm 3 (ß= -2.61, 95% CI: -4.21; -1.00, P = 0.0015 and ß=-1.35, 95% CI: -2.50; -0.21, P = 0.02). CONCLUSION: MI reduces the burden of physical HF symptoms, particularly when caregivers are involved in the intervention.

Prevalence of hypertension mediated organ damage in subjects with high-normal blood pressure without known hypertension as well as cardiovascular and kidney disease.

Purpose of our study was to assess the prevalence of hypertension mediated organ damage (HMOD) in healthy subjects with high-normal Blood Pressure (BP) comparing them with subjects with BP values that are considered normal (<130/85 mmHg) or indicative of hypertension (≥140/90 mmHg). Seven hundred fifty-five otherwise healthy subjects were included. HMOD was evaluated as pulse wave velocity (PWV), left ventricular mass index (LVMI), and carotid intima-media thickness (IMT) and plaque. When subjects were classified according to BP levels we found that the high-normal BP group showed intermediate values of PWV and higher values of IMT. This corresponds to intermediate prevalence of arterial stiffness, while there were no differences for increased IMT or carotid plaque. No subjects showed left ventricular hypertrophy. At multivariable analysis, the odds of having arterial stiffness or carotid HMOD in the high-normal group resulted not different to the normal group. In conclusion, in our otherwise healthy population, high-normal BP values were not related to aortic, carotid or cardiac HMOD.

Atrial Fibrillation and Clinical Outcomes in a Cohort of Hospitalized Patients with Sars-Cov-2 Infection and Chronic Kidney Disease.

The aim of the study was to investigate the role of chronic kidney disease (CKD) on in-hospital mortality and on incident atrial fibrillation (AF) in patients infected with SARS-CoV-2. The incidence of acute kidney injury (AKI) was also investigated. Multivariable regression models were used to assess the association between renal function groups (estimated Glomerular Filtration Rate, eGFR, >60 mL/min, 30-59 mL/min, <30 mL/min) and in-hospital all-cause mortality and incident AF and AKI. A cohort of 2816 patients admitted in one year for COVID-19 disease in two large hospitals was analyzed. The independent predictors of mortality were severe CKD [HR 1.732 (95%CI 1.264-2.373)], older age [HR 1.054 (95%CI 1.044-1.065)], cerebrovascular disease [HR 1.335 (95%CI (1.016-1.754)], lower platelet count [HR 0.997 (95%CI 0.996-0.999)], higher C-reactive protein [HR 1.047 (95%CI 1.035-1.058)], and higher plasma potassium value 1.374 (95%CI 1.139-1.658). When incident AKI was added to the final survival model, it was associated with higher mortality [HR 2.202 (1.728-2.807)]. Incident AF was more frequent in patients with CKD, but in the multivariable model only older age was significantly related with a higher incidence of AF [OR 1.036 (95%CI 1.022-1.050)]. Incident AF was strongly associated with the onset of AKI [HR 2.619 (95%CI 1.711-4.009)]. In this large population of COVID-19 patients, the presence of severe CKD was an independent predictor of in-hospital mortality. In addition, patients who underwent AKI during hospitalization had a doubled risk of death. Incident AF became more frequent as eGFR decreased and it was significantly associated with the onset of AKI.

Effectiveness of motivational interviewing on health-service use and mortality: a secondary outcome analysis of the MOTIVATE-HF trial.

AIMS: Intense health-care service use and high mortality are common in heart failure (HF) patients. This secondary analysis of the MOTIVATE-HF trial investigates the effectiveness of motivational interviewing (MI) in reducing health-care service use (e.g. emergency service use and hospitalizations) and all-cause mortality. METHODS AND RESULTS: This study used a randomized controlled trial. Patients and caregivers were randomized to Arm 1 (MI for patients), Arm 2 (MI for patients and caregivers), or Arm 3 (control group). Data were collected at baseline and at 3, 6, 9, and 12 months. Face-to-face MI plus three telephone calls were performed in Arms 1 and 2. The sample consisted of 510 patient (median age 74 years, 58% male patients) and caregiver dyads (median age 55 years, 75% female patients). At 12 months, 16.1%, 17%, and 11.2% of patients used health-care services at least once in Arms 1, 2, and 3, respectively, without significant difference. At 3 months, 1.9%, 0.6%, and 5.1% of patients died in Arms 1, 2, and 3, respectively. Mortality was lower in Arm 2 vs. Arm 3 at 3 months [hazard ratio (HR) = 0.112, 95% CI: 0.014-0.882, P = 0.04]; no difference was found at subsequent follow-ups. Mortality was lower in Arm 1 vs. Arm 3 at 3 months but did not reach statistical significance (HR = 0.38, 95% CI: 0.104-1.414, P = 0.15). CONCLUSION: This study suggests that MI reduces mortality in patients with HF if caregivers are included in the intervention. Further studies with a stronger intervention and longer follow-up are needed to clarify the benefits of MI on health-care service use and mortality.

Effectiveness of motivational interviewing on anxiety, depression, sleep quality and quality of life in heart failure patients: secondary analysis of the MOTIVATE-HF randomized controlled trial.

PURPOSE: Anxiety, depression, poor sleep quality and lower quality of life (QOL) are associated with worse outcomes in heart failure (HF) patients. Motivational interview (MI) has been effective in different patient populations to promote self-care. However, its effect on anxiety, depression, sleep quality and QOL in HF patients is unknown. The aim of this study was to evaluate the effect of MI on anxiety, depression, sleep quality and QOL over 12 months from the intervention. METHODS: This was a planned, secondary outcome analysis of the MOTIVATE-HF study, a three-arm randomized controlled trial (1:1:1) evaluating the effect of MI in improving self-care in HF patients. In Arm 1, the patient received MI, while in Arm 2, the patient and the caregiver received MI. Arm 3, the control group, received standard treatment. Endpoints were evaluated with the Hospital Anxiety and Depression Scale (HADS), the Pittsburgh Sleep Quality Index (PSQI), the 12-Item Short-Form Health Survey (SF-12) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) every three months for one year. RESULTS: We enrolled and randomized 510 HF patient and caregiver dyads (155 dyads in Arm 1, 177 dyads in Arm 2, and 178 dyads in Arm 3). A total of 238 HF patients and 235 caregivers completed the 12-month trial. No significant changes were seen in anxiety, depression and sleep quality over time among the three study arms, but disease-specific QOL improved in the intervention groups, especially in Arm 2. CONCLUSION: Clinicians may want to include both patients and caregivers when providing MI interventions. Further research is needed to investigate the required intensity of MI to be effective on sleep quality, anxiety and depression (ClinicalTrials.gov Identifier: NCT02894502).

Kidney Dysfunction and the Risk of Developing Aortic Stenosis.

BACKGROUND: Chronic kidney disease (CKD) and aortic stenosis (AS) share many risk factors. OBJECTIVES: This study sought to evaluate whether kidney dysfunction is associated with the development of AS in the community. METHODS: The study included 1,121,875 Stockholm citizens without a prior diagnosis of AS from the SCREAM (Stockholm CREAtinine Measurements) project. Estimated glomerular filtration rate (eGFR) (ml/min/1.73 m2) was calculated from serum creatinine. AS incidence during follow-up was ascertained by clinical diagnostic codes. The association between eGFR and AS incidence was estimated with multivariable Cox proportional hazards models. Sensitivity analyses included analysis of possible reverse causation bias by excluding the first 6 months to 2 years after enrollment and excluding individuals with comorbid heart failure. RESULTS: The median age was 50 years (interquartile range [IQR]: 36 to 64 years), and 54% of participants were women. Median eGFR was 96 ml/min/1.73 m2 (IQR: 82 to 109 ml/min/1.73 m2), and 66,949 (6.0%) participants had CKD (eGFR <60 ml/min/1.73 m2). During a median follow-up of 5.1 years (IQR: 3.3 to 6.1 years), 5,858 (0.5%) individuals developed AS (incidence rate [IR] 1.13/1,000 person-years). Compared with eGFR >90 (IR 0.34/1,000 person-years), lower eGFR strata were associated with higher hazards of AS: eGFR 60 to 90 ml/min/1.73 m2; IR: 1.88; hazard ratio (HR): 1.14; 95% confidence interval (CI): 1.05 to 1.25; eGFR 45 to 59 ml/min/1.73 m2; IR: 4.61; HR: 1.17; 95% CI: 1.05 to 1.30; eGFR 30 to 44 ml/min/1.73 m2; IR: 6.62; HR: 1.22; 95% CI: 1.07 to 1.39; and eGFR 30 ml/min/1.73 m2; IR: 8.27; HR: 1.56; 95% CI: 1.29 to 1.87. Sensitivity analysis attenuated only slightly the magnitude of the association; individuals with eGFR ≤44 ml/min/1.73 m2 remained at an approximate 20% risk of AS both when excluding events within the 2 years after baseline (HR: 1.22; 95% CI: 1.06 to 1.42) and when excluding participants with heart failure (HR: 1.20; 95% CI: 1.03 to 1.39). CONCLUSIONS: CKD, even in moderate to severe stages, is associated with an increased risk of AS.