scholarly journals Frailty phenotypes in patients with heart failure in the early post-discharge period: insights from the iCOR randomised controlled trial and a machine learning-based clustering analysis

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Yun Viladomat ◽  
C Enjuanes Grau ◽  
E Calero Molina ◽  
E Hidalgo Quiros ◽  
N Jose Bazan ◽  
...  
Keyword(s):  
Machine Learning ◽  
Heart Failure ◽  
Primary Endpoint ◽  
Clustering Analysis ◽  
Functional Dependence ◽  
Controlled Trial ◽  
Self Care ◽  
Number Of Clusters ◽  
Level Of Education

Abstract Background/Introduction Several variables such as clinical, socioeconomic, functional or cognitive, among others can have an impact on the prognosis of heart failure (HF) patients despite the optimisation of follow-up strategies (e.g. telemedicine [TM] solutions). The clustering of HF patients may to identify different patient frailty phenotypes. Purpose The aim of this study was to perform a machine learning-based clustering analysis to identify different patient frailty phenotypes in a cohort of HF patients recruited in a randomized clinical trial (The Insuficiència Cardíaca Optimitzaciό Remota [iCOR] study). Methods We performed the clustering analysis on the basis of 8 frailty-related dimensions. To define the number of clusters, dissimilarity matrix was calculated with Gower's distance. Then, hierarchical divisive clustering was performed. Using then Elbow and Silhouette to analyse how the within sum of squares changes for the different number of clusters, the final number of clusters were chosen. The incidence proportion of the each of the study endpoints (non-fatal HF events as primary endpoint and all-cause hospitalization, all-cause death and the composite endpoint combining of all-cause death or non-fatal HF events as secondary endpoints) was calculated for cluster. Results 5 different frailty phenotypes were identified. Cluster 1 (29 patients, 16%) comprised patients with the best reported self-perceived health status (QoL), fair emotional-affective status, but low levels of self-care. Cluster 2 (41 patients, 23%) included the youngest patients with the highest level of education and a better level of cognition. Cluster 3 (68, 38%) encompassed the patients who had the best level of self-care behaviour (18.9±9.8), greater physical and instrumental functioning for activities of daily living (ADL) and a lower rate of comorbidities. Patients in the Cluster 4 (30 patients, 17%) tended to be elderly females with poor health-related QoL, and a higher level of functional dependence. Finally, Cluster 5 was the smallest group (10 patients, 6%), encompassing the oldest patients with low level of education, a worse affective-emotional state, a significant cognitive decline and a higher proportion of comorbidities compared to the other clusters. Cluster 4 had the highest incidence rate of the primary endpoint (57 per 100 patient-years at risk, 95% CI [37.4–74–5]) and a higher incidence of all-cause hospitalization and of the combined variable of all-cause of death or non-fatal HF events. Conclusion(s) Using the cluster analysis, we were able to stratify HF patients according to the stage of their impairment and vulnerability in each of the different frailty domains. This will allow clinicians to incorporate holistic multi-domain assessments in HF programmes to identify patients' needs and provide each patient with personalised and structured follow-up programme according to patient's needs (personalised and precision medicine). FUNDunding Acknowledgement Type of funding sources: None. Radar chart to compare frailty clusters Clinical endpoints according clusters

scholarly journals Effectiveness of telemedicine in patients with heart failure according to frailty phenotypes: insights from the iCOR randomised controlled trial

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Yun Viladomat ◽  
C Enjuanes Grau ◽  
E Calero Molina ◽  
E Hidalgo Quiros ◽  
N Jose Bazan ◽  
...  
Keyword(s):  
Heart Failure ◽  
Primary Endpoint ◽  
Cox Regression ◽  
Controlled Trial ◽  
Cox Proportional Hazards ◽  
P Value ◽  
Post Discharge ◽  
Secondary Endpoints ◽  
Positive Effect

Abstract Background/Introduction The potential impact of telemedicine (TM) in the monitoring of heart failure (HF) patients is still uncertain, largely due to the heterogeneity of the studies published to date. A subgroup of patients in which its key role is particularly uncertain is that of the frailest patients mainly due to TM-based strategies have been often discouraged on the basis of a foreseeable limited benefit in them. Purpose The aim of this study was to define the efficacy of a TM-based managed care solution across different HF patient frailty phenotypes in a cohort of HF patients recruited in a randomized clinical trial (The Insuficiència Cardíaca Optimitzaciό Remota [iCOR] study) evaluating the efficacy of a TM-based management compared to usual care (UC) in the early post-discharge period. Methods Five previously described frailty clusters were analysed. Cox proportional-hazards regression models were used to evaluate the effect of each cluster and group of treatment (and its interaction) on a series of endpoints (the incidence of non-fatal HF events as primary endpoint and all-cause hospitalization, all-cause death and the composite endpoint combining of all-cause death or non-fatal HF events as secondary endpoints). The incidence proportion of the first occurrence of each of the study endpoints was calculated for each study arm and for cluster, and these compared using χ2 tests. Additionally, a survival analysis was conducted using Cox regression to describe the event-free survival experience of the combination of the clusters with each of the 2 treatment groups for the study endpoints evaluated, and p-value was used to compare the different curves. Results The positive effect of TM compared to UC strategy was consistent across all frailty phenotypes (p-value for interaction 0.711). The risk of experiencing a primary event was significantly lower in patients that underwent allocation to the TM arm compared to UC (p-value=0.016). As shown for the primary endpoint, the positive effect of TM compared to UC strategy was consistent across all frailty phenotypes also for the secondary endpoints (all p-value for interaction >0.05). Likewise, the risk of all-cause hospitalization or the composite end-point of all-cause death or non-fatal HF event was significantly lower in patients that underwent allocation to the TM arm compared to UC (p-value=0.030 and 0.016 respectively). However, the risk of all-cause death did not differ across subgroup strata (p-value>0.05). Conclusion(s) This study showed that non-invasive TM-based follow-up tools are effective compared to UC in preventing fatal and non-fatal adverse events in the early post-discharge period, regardless of the 5 different frailty phenotypes. Importantly, when comparing TM-based follow-up with UC management in patients belonging to equal frailty cluster, those who were followed-up by eHealth had a considerably lower risk of non-fatal HF events, hospitalization or death. FUNDunding Acknowledgement Type of funding sources: None. Cox regression non-fatal HF events Cox regression all-cause hospitalization

A patient-centered mobile intervention to promote self-management and improve patient outcomes in chronic heart failure: The ManageHF4Life trial (Preprint)

2020 ◽  
Author(s):  
Michael P. Dorsch ◽  
Karen B. Farris ◽  
Brigid E. Rowell ◽  
Scott L. Hummel ◽  
Todd M. Koelling
Keyword(s):  
Heart Failure ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Self Management ◽  
Control Group ◽  
Patient Centered ◽  
Self Monitoring ◽  
Heart Failure Questionnaire

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

Twin peaks diversity with sacubitril/valsartan treatment responses in cardiomyopathic heart failure patients of non-ischemic compared to ischemic etiologies

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H.Y Chang ◽  
W.R Chiou ◽  
P.L Lin ◽  
C.Y Hsu ◽  
C.T Liao ◽  
...  
Keyword(s):  
Heart Failure ◽  
Primary Endpoint ◽  
Ischemic Cardiomyopathy ◽  
Ventricular Remodeling ◽  
Left Ventricular Ejection ◽  
Funding Source ◽  
Heart Failure Patients ◽  
Twin Peaks ◽  
All Cause Mortality

Abstract Background Ischemic cardiomyopathy (ICM) has been associated with increased mortality when compared with non-ischemic cardiomyopathy (NICM) from several heart failure (HF) cohorts. Instead, PARADIGM study demonstrated similar event rates of cardiovascular (CV) death, all-cause mortality and HF readmissions between ICM and NICM patients. Although the beneficiary effect of sacubitril/valsartan (SAC/VAL) compared to enalapril on these endpoints was consistent across etiologic categories, PARADIGM study did not analyze the effect of ventricular remodeling of SAC/VAL on patients with different HF etiologies, which may significantly affect treatment outcomes. Purpose We aim to compare alterations of left ventricular ejection fraction (LVEF) following SAC/VAL treatment and its association with clinical outcomes in patients with different HF etiologies. Methods Treatment with angiotensin receptor neprilysin inhibitor for Taiwan heart failure patients (TAROT-HF) study is a multicenter study which enrolled 1552 patients with LVEF <40%, whom had been on SAC/VAL treatment from 9 hospitals between 2017 and 2018. After excluding patients without having follow-up echocardiographic studies, patients were grouped by HF etiologies and by LVEF changes following treatment for 8-month period. LVEF improvement ≥15% was defined as “significant improvement”, 5–15% as “marginal improvement”, and <5% or worse as “lack of improvement”. The primary endpoint was a composite of CV death or a first hospitalization for HF. Mean follow-up period was 726 days. Results A total of 1230 patients were analyzed. Patients with ICM were significantly older, more male, and prone to have associated hypertension and diabetes. On the other hand, patients with NICM had lower LVEF and higher likelihood of atrial fibrillation. LVEF increase was significantly greater in patients with NICM compared to those with ICM (11.2±12.4% vs. 6.9±9.8, p<0.001). The effect of ventricular remodeling of SAC/VAL on patients with NICM showed twin peaks diversity (Significant improvement 37.1%, lack of improvement 42.3%), whereas in patients with ICM the proportions of significant, marginal and lack of improvement groups were 19.4%, 28.2% and 52.4%, respectively. The primary endpoint showed twin peaks diversity also in patients with NICM in line with LVEF changes: adjusted HR for patients with NICM and significant improvement was 0.41 (95% CI 0.29–0.57, p<0.001), for patients with NICM and lack of improvement was 1.54 (95% CI 1.22–1.94, p<0.001). Analyses for CV death, all-cause mortality, and HF readmission demonstrated consistent results. Conclusion Patients with NICM had higher degree of LVEF improvement than those with ICM following SAC/VAL treatment, and significant improvement of LVEF in NICM patients may indicate favorable outcome. NICM patients without response to SAC/VAL treatment should serve as an indicator for poor clinical outcome and warranted meticulous HF management. Funding Acknowledgement Type of funding source: Private hospital(s). Main funding source(s): Cheng Hsin General Hospital

scholarly journals Serially measured cytokines and cytokine receptors in relation to clinical outcome in patients with stable heart failure

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Bouwens ◽  
A Schuurman ◽  
K.M Akkerhuis ◽  
S.J Baart ◽  
K Caliskan ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Outcome ◽  
Primary Endpoint ◽  
Nyha Class ◽  
Cytokine Receptors ◽  
Funding Source ◽  
Compensatory Mechanism ◽  
Blood Samples ◽  
Two Samples

Abstract Background Activation of the inflammatory response in heart failure (HF) may initially serve as a compensatory mechanism. However, on the longer term, this physiological phenomenon can become disadvantageous. Temporal patterns of inflammatory proteins other than CRP have not yet been investigated in patients with stable HF. Purpose We aimed to evaluate the association of 17 serially measured cytokines and cytokine receptors with clinical outcome in patients with stable heart failure. Methods In 263 patients, 1984 serial, tri-monthly blood samples were collected during a median follow-up of 2.2 (IQR: 1.4–2.5) years. The primary endpoint (PE) composed of cardiovascular mortality, HF-hospitalization, heart transplantation, and LVAD. We selected baseline blood samples in all patients, as well as the two samples closest to the primary endpoint, and the last sample available in event-free patients. Thus, in 567 samples we measured 17 cytokines and cytokine receptors using the Olink Proteomics Cardiovascular III multiplex assay. Associations between biomarkers and PE were investigated by joint modelling. Results Median age was 68 (IQR: 59–76) years, with 72% men, 74% NYHA class I-II and a median ejection fraction of 30% (23–38%). 70 patients reached a PE. After adjustment for clinical characteristics (age, sex, diabetes, atrial fibrillation, NYHA class at baseline, diuretics and systolic blood pressure), 7 biomarkers were associated with the PE (Figure). Interleukin-1 receptor type 1 (IL1RT1) showed the strongest association: HR 2.65 [95% CI: 1.78–4.21]) per standard deviation change in level (NPX) at any point in time during follow-up, followed by Tumor necrosis factor receptor 1 (TNF-R1): 2.25 [1.66–3.08], and C-X-C motif chemokine 16 (CXCL16): 2.18 [1.59–3.04]. After adjustment for baseline N-terminal pro–B-type natriuretic peptide, high-sensitive troponin T and C-reactive protein however, only IL1RT1 and TNF-R1 remained significantly associated with the PE. Conclusion Repeatedly measured levels of several cytokines and cytokine receptors are independently associated with clinical outcome in stable HF patients. These results suggest that repeated measurements of these biomarkers, in addition to established cardiac biomarkers, may contribute to personalized risk assessment and herewith better identify high-risk patients. Figure 1. Associations between levels of cytokines and cytokine receptors and the primary endpoint. Funding Acknowledgement Type of funding source: Other. Main funding source(s): This work was supported by the Jaap Schouten Foundation and the Noordwest Academie.

scholarly journals Does Symptom Recognition Improve Self-Care in Patients with Heart Failure? A Pilot Study Randomised Controlled Trial

2021 ◽  
Vol 11 (2) ◽  
pp. 418-429
Author(s):  
Joana Pereira Sousa ◽  
Hugo Neves ◽  
Miguel Pais-Vieira
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Care Management ◽  
Controlled Trial ◽  
Self Care ◽  
Fluid Restriction ◽  
Symptom Recognition ◽  
Patients With Heart Failure ◽  
Randomised Controlled

Patients with heart failure have difficulty in self-care management, as daily monitoring and recognition of symptoms do not readily trigger an action to avoid hospital admissions. The purpose of this study was to understand the impact of a nurse-led complex intervention on symptom recognition and fluid restriction. A latent growth model was designed to estimate the longitudinal effect of a nursing-led complex intervention on self-care management and quality-of-life changes in patients with heart failure and assessed by a pilot study performed on sixty-three patients (33 control, 30 intervention). Patients in the control group had a higher risk of hospitalisation (IRR 11.36; p < 0.001) and emergency admission (IRR 4.24; p < 0.001) at three-months follow-up. Analysis of the time scores demonstrated that the intervention group had a clear improvement in self-care behaviours (βSlope. Assignment_group = −0.881; p < 0.001) and in the quality of life (βSlope. Assignment_group = 1.739; p < 0.001). This study supports that a nurse-led programme on symptom recognition and fluid restriction can positively impact self-care behaviours and quality of life in patients with heart failure. This randomised controlled trial was retrospectively registered (NCT04892004).

scholarly journals Paradox of self-care gender differences among Italian patients with chronic heart failure: findings from a real-world cross-sectional study

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e021966 ◽  
Author(s):  
Federica Dellafiore ◽  
Cristina Arrigoni ◽  
Francesco Pittella ◽  
Gianluca Conte ◽  
Arianna Magon ◽  
...  
Keyword(s):  
Heart Failure ◽  
Gender Differences ◽  
Chronic Heart Failure ◽  
Real World ◽  
Self Care ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Caregiver Relationship

AimThe aim of this study was to critically analyse and describe gender differences related to self-care among patients with chronic heart failure (HF).Methods and resultsA monocentric real-world cohort of 346 patients with chronic HF in follow-up was used for this cross-sectional study. We report data related to the cohort’s demographic and clinical characteristics. Self-care was assessed using the Self-Care of Heart Failure Index before patients’ discharge. After bivariate analysis, logistical regression models were used to describe the relationship between gender, self-care behaviours and self-care confidence. While men were found to have more than quadruple the risk of poor self-care than women (OR 4.596; 95% CI 1.075 to 19.650), men were also found to be approximately 60% more likely to have adequate self-care confidence than women (OR 0.412; 95% CI 0.104 to 0.962). Considering that self-care confidence is described as a positive predictor of behaviours, our results suggest a paradox. It is possible that the patient–caregiver relationship mediates the effect of confidence on behaviours. Overall, adequate levels of self-care behaviours are a current issue, ranging 7.6%–18.0%.ConclusionThis study sets the stage for future research where elements of the patient–caregiver relationship ought to be considered to inform the planning of appropriate educational interventions. We recommend routinely measuring patients’ self-care behaviours to guide their follow-up and as a basis for any changes in their daily life behaviours.

scholarly journals Results Are Similar Two Years After Acute or Delayed Anterior Cruciate Ligament Reconstruction. A Randomized Controlled Trial

2017 ◽  
Vol 5 (5_suppl5) ◽  
pp. 2325967117S0017
Author(s):  
Karl Eriksson ◽  
Christoffer von Essen ◽  
Björn Barenius
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Endpoint ◽  
Pivot Shift ◽  
Controlled Trial ◽  
Acl Injury ◽  
Activity Level ◽  
Randomized Controlled ◽  
Delayed Group ◽  
The Mean

Objectives: Acute ACLR has been avoided since the 1990’s due to reports of postoperative stiffness. But are these risks still valid with modern arthroscopic techniques? The aim of this randomized controlled trial was to assess the impact of the time between injury and reconstruction on the outcome after ACLR. Our hypothesis was that acute ACLR with semitendinosus graft can be performed safely. Methods: The primary endpoint was ROM at three months after surgery. A power calculation revealed the need for 64 patients to detect a ROM difference of 5 degrees between the groups (5% significance level). 70 patients with a high recreational activity level (Tegner ≥6) who presented with an acute ACL injury were randomized to an acute reconstruction within 8 days from the injury or delayed reconstruction (after normalized ROM) 6-10 weeks after the injury. Fixation was with Endobutton in femur and a metallic interference screw in tibia. The rehabilitation was performed at the same physiotherapy center for all patients. Follow up assessment was performed by a physiotherapist not involved with the rehabilitation. The follow up at 24 months included ROM, Lachman, instrumented laxity with Rolimeter, pivot shift, one leg hop index, Biodex, IKDC, KOOS, Lysholm and Tegner Activity level, and a VAS question regarding knee function and the knee function’s effect on activity level. Results: Seventy percent of the patients were males, mean age at the time of surgery was 27 years (18 -41) and the median pre-injury Tegner level was 9 (6-10) with no differences between the groups. 64 (91%) patients were assessed at three months with no difference according to the primary endpoint. Median Tegner level was restored to pre-injury levels in both groups after one year, and did not change between one and two years. 63 (90%) patients were available for the 2-year follow up. There was one graft rupture and one contralateral ACL injury in both groups. There was additional surgery in 15% of the acute patients and in 31% in the delayed (n.s.). The mean instrumented laxity was 1.8 mm in the acute and 2.0 in the delayed group. There were no positive pivot shift in the acute group and 6 patients with grade 1 or not possible to perform in the delayed group (p=0.039). IKDC revealed no significant differences between the groups. Lysholm score was 87 in both groups. KOOS values showed no significant difference between the groups. VAS response to the question “How is your knee working on a scale from 0-100? (100 = best)” was 81 in the acute and 71 in the delayed group (p=0.1) and “How does your knee affect your activity level? (100 = no affection)” the mean score was 75 in the acute and 67 in the delayed group (p=0.3). Functional strength (one leg hop index >90%) was 85% in the acute and 67% in the delayed group (n.s). Conclusion: We found no increased risk of arthrofibrosis after acute ACLR. Good results can be achieved at two years regardless of ROM and swelling in the acute stage.

scholarly journals From randomised controlled trial to real world implementation of a novel home-based heart failure tool: pooled and comparative analyses of two clinical controlled trials

Open Heart ◽  
2019 ◽  
Vol 6 (1) ◽  
pp. e000954 ◽  
Author(s):  
Ann Hovland-Tånneryd ◽  
Michael Melin ◽  
Ewa Hägglund ◽  
Inger Hagerman ◽  
Hans E Persson
Keyword(s):  
Heart Failure ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Self Care ◽  
Control Group ◽  
Data Set ◽  
Pooled Data ◽  
Home Based ◽  
Randomised Controlled ◽  
Hospital Days

ObjectivesA home-based tool for heart failure (HF) patients, was evaluated in a specialist setting as a randomised controlled trial (RCT) and also in a validation cohort in a primary care setting in a clinical controlled trial (CCT). The tool provides education, symptom monitoring and titration of diuretics. The aim of this study was thus to extend validity of the previous RCT findings in order to describe applicability of the tool in clinical practice.MethodsData from both trials were analysed separately, as well as a pooled data set (n=172). Data were analysed with respect to HF related in-hospital days, self-care behaviour and system adherence, during a 6-month intervention. The analysis of in-hospital days for the pooled data was adjusted for baseline differences between the two study cohorts, relating to disease state.ResultsIn the RCT (n=72) the intervention group (IG) consisted of 32 patients and the control group (CG) of 40 patients. The risk ratio (RR) for in-hospital days was RR: 0.72, 95% CI 0.61 to 0.84, p<0.05 in favour of the IG. In the CCT (n=100) both the IG and the CG consisted of 50 patients and the IG had fewer in-hospitals days, comparable to the RCT findings with RR: 0.67; 95% CI 0.45 to 0.99; p<0.05. For the pooled data set made up of 172 patients, the groups were well balanced but with a higher prevalence of hypertension in the CG. The RR relating to in-hospital days for the pooled data set was 0.71; 95% CI 0.61 to 0.82; p<0.05 in favour of the IG. There was a statistically significant improvement in self-care by 27% and the median system adherence was 94%.ConclusionsThese analyses suggest that the evaluated tool might reduce HF related in-hospital days in the general HF population, which adds to the external validity of previous findings.Clinical Trial RegistrationNCT03655496.

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