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A Novel Intelligent Two-Way Communication System for Remote Heart Failure Medication Uptitration (the CardioCoach Study): Randomized Controlled Feasibility Trial.

ABSTRACT: BACKGROUND:European Society of Cardiology guidelines for the treatment of heart failure (HF) prescribe uptitration of angiotensin-converting enzyme inhibitors (ACE-I) and ?-blockers to the maximum-tolerated, evidence-based dose. Although HF prognosis can drastically improve when correctly implementing these guidelines, studies have shown that they are insufficiently implemented in clinical practice. OBJECTIVE:The aim of this study was to verify whether supplementing the usual care with the CardioCoach follow-up tool is feasible and safe, and whether the tool is more efficient in implementing the guideline recommendations for ?-blocker and ACE-I. METHODS:A total of 25 HF patients were randomly assigned to either the usual care control group (n=10) or CardioCoach intervention group (n=15), and observed for 6 months. The CardioCoach follow-up tool is a two-way communication platform with decision support algorithms for semiautomatic remote medication uptitration. Remote monitoring sensors automatically transmit patient's blood pressure, heart rate, and weight on a daily basis. RESULTS:Patients' satisfaction and adherence for medication intake (10,018/10,825, 92.55%) and vital sign measurements (4504/4758, 94.66%) were excellent. However, the number of technical issues that arose was large, with 831 phone contacts (median 41, IQR 32-65) in total. The semiautomatic remote uptitration was safe, as there were no adverse events and no false positive uptitration proposals. Although no significant differences were found between both groups, a higher number of patients were on guideline-recommended medication dose in both groups compared with previous reports. CONCLUSIONS:The CardioCoach follow-up tool for remote uptitration is feasible and safe and was found to be efficient in facilitating information exchange between care providers, with high patient satisfaction and adherence. TRIAL REGISTRATION:ClinicalTrials.gov NCT03294811; https://clinicaltrials.gov/ct2/show/NCT03294811 (Archived by WebCite at http://www.webcitation.org/6xLiWVsgM).

SUBMITTER: Smeets CJ

PROVIDER: S-EPMC6834244 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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A Novel Intelligent Two-Way Communication System for Remote Heart Failure Medication Uptitration (the CardioCoach Study): Randomized Controlled Feasibility Trial.

Smeets Christophe Jp CJ Storms Valerie V Vandervoort Pieter M PM Dreesen Pauline P Vranken Julie J Houbrechts Marita M Goris Hanne H Grieten Lars L Dendale Paul P

JMIR cardio 20180404 1

<h4>Background</h4>European Society of Cardiology guidelines for the treatment of heart failure (HF) prescribe uptitration of angiotensin-converting enzyme inhibitors (ACE-I) and β-blockers to the maximum-tolerated, evidence-based dose. Although HF prognosis can drastically improve when correctly implementing these guidelines, studies have shown that they are insufficiently implemented in clinical practice.<h4>Objective</h4>The aim of this study was to verify whether supplementing the usual care ...[more]

PMID: 31758773

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Project description:BACKGROUND:Heart failure (HF) is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality. With an aging population, the cost associated with managing HF is expected to more than double from US $31 billion in 2012 to US $70 billion by 2030. Readmission rates for HF patients are high-25% are readmitted at 30 days and nearly 50% at 6 months. Low medication adherence contributes to poor HF management and higher readmission rates. Remote telehealth monitoring programs aimed at improved medication management and adherence may improve HF management and reduce readmissions. OBJECTIVE:The primary goal of this randomized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program. We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department (ED) visits, increased medication adherence, and improved health-related quality of life (HRQoL) compared to usual care. METHODS:Participants were randomized to usual care or use of the remote medication monitoring system for 90 days. Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants. Participants completed questionnaires at enrollment and closeout to gather data on medication adherence, health status, and HRQoL. Electronic medical records were reviewed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period. RESULTS:Use of the medication monitoring system was associated with an 80% reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care. Objective device data indicated high adherence rates (95%-99%) among intervention group participants despite finding no significant difference in self-reported adherence between study arms. The intervention group had poorer heart function and HRQoL at baseline, and HRQoL declined significantly in the intervention group compared to controls. CONCLUSIONS:The MedSentry medication monitoring system is a promising technology that merits continued development and evaluation. The MedSentry medication monitoring system may be useful both as a standalone system for patients with complex medication regimens or used to complement existing HF telemonitoring interventions. We found significant reductions in risk of all-cause hospitalization and the number of all-cause length of stay in the intervention group compared to controls. Although HRQoL deteriorated significantly in the intervention group, this may have been due to the poorer HF-functioning at baseline in the intervention group compared to controls. Telehealth medication adherence technologies, such as the MedSentry medication monitoring system, are a promising method to improve patient self-management,the quality of patient care, and reduce health care utilization and expenditure for patients with HF and other chronic diseases that require complex medication regimens. TRIAL REGISTRATION:ClinicalTrials.gov NCT01814696; https://clinicaltrials.gov/ct2/show/study/NCT01814696 (Archived by WebCite® at http://www.webcitation.org/6giqAVhno).

Project description:AimsThis study aimed to assess the ability of a voice analysis application to discriminate between wet and dry states in chronic heart failure (CHF) patients undergoing regular scheduled haemodialysis treatment due to volume overload as a result of their chronic renal failure.Methods and resultsIn this single-centre, observational study, five patients with CHF, peripheral oedema of ≥2, and pulmonary congestion-related dyspnoea, undergoing haemodialysis three times per week, recorded five sentences into a standard smartphone/tablet before and after haemodialysis. Recordings were provided that same noon/early evening and the next morning and evening. Patient weight was measured at the hospital before and after each haemodialysis session. Recordings were analysed by a smartphone application (app) algorithm, to compare speech measures (SMs) of utterances collected over time. On average, patients provided recordings throughout 25.8 ± 3.9 dialysis treatment cycles, resulting in a total of 472 recordings. Weight changes of 1.95 ± 0.64 kg were documented during cycles. Median baseline SM prior to dialysis was 0.87 ± 0.17, and rose to 1.07 ± 0.15 following the end of the dialysis session, at noon (P = 0.0355), and remained at a similar level until the following morning (P = 0.007). By the evening of the day following dialysis, SMs returned to baseline levels (0.88 ± 0.19). Changes in patient weight immediately after dialysis positively correlated with SM changes, with the strongest correlation measured the evening of the dialysis day [slope: -0.40 ± 0.15 (95% confidence interval: -0.71 to -0.10), P = 0.0096].ConclusionsThe fluid-controlled haemodialysis model demonstrated the ability of the app algorithm to identify cyclic changes in SMs, which reflected bodily fluid levels. The voice analysis platform bears considerable potential as a harbinger of impending fluid overload in a range of clinical scenarios, which will enhance monitoring and triage efforts, ultimately optimizing remote CHF management.

Project description:BackgroundGuideline-directed medical therapy (GDMT), optimized to target doses, improves health outcomes in patients with heart failure. However, GDMT remains underused, with <25% of patients receiving target doses in clinical practice. A randomized controlled trial was conducted at the Peter Munk Cardiac Centre in Toronto to compare a remote GDMT titration intervention with standard in-office titration. This randomized controlled trial found that remote titration increased the proportion of patients who achieved optimal GDMT doses, decreased the time to dose optimization, and reduced the number of essential clinic visits. This paper presents findings from the qualitative component of the mixed methods study, which evaluated the implementation of the remote titration intervention.ObjectiveThe objective of the qualitative component is to assess the perceptions and experiences of clinicians and patients with heart failure who participated in the remote titration intervention to identify factors that affected the implementation of the intervention.MethodsWe conducted semistructured interviews with clinicians (n=5) and patients (n=11) who participated in the remote titration intervention. Questions probed the experiences of the participants to identify factors that can serve as barriers and facilitators to its implementation. Conventional content analysis was first used to analyze the interviews and gain direct information based on the participants' unique perspectives. Subsequently, the generated themes were delineated and mapped following a multilevel framework.ResultsPatients and clinicians indicated that the intervention was easy to use, integrated well into their routines, and removed practical barriers to titration. Key implementation facilitators from the patients' perspective included the reduction in clinic visits and daily monitoring of their condition, whereas clinicians emphasized the benefits of rapid drug titration and efficient patient management. Key implementation barriers included the resources necessary to support the intervention and lack of physician remuneration.ConclusionsThis study presents results from a real-world implementation assessment of remote titration facilitated by telemonitoring. It is among the first to provide insight into the perception of the remote titration process by clinicians and patients. Our findings indicate that the relative advantages that remote titration presents over standard care strongly appeal to both clinicians and patients. However, to ensure uptake and adherence, it is important to ensure that suitable patients are enrolled and the impact on the physicians' workload is minimized. The implementation of remote titration is now more critical than ever, as it can help provide access to care for patients during times when physical distancing is required.Trial registrationClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513.International registered report identifier (irrid)RR2-10.2196/19705.

Project description:BackgroundInitiation and up-titration of guideline-directed medical therapies (GDMTs) for heart failure with reduced ejection fraction (HFrEF) remains suboptimal, in part because of concerns regarding tolerability and adverse events (AEs).ObjectivesThe authors sought to compare rates of AE in patients randomized to GDMT medication vs placebo in a meta-analysis of landmark cardiovascular outcomes trials.MethodsThe authors assessed rates of reported AE in 17 landmark HFrEF clinical trials across each class of GDMT in the placebo and intervention arms. The overall rates of AE for each drug class, the absolute difference in frequency in AEs between the placebo and intervention arms, and the odds of each AE according based on randomization strata were calculated.ResultsAE were reported commonly in trials across each class of GDMT, with 75% to 85% of participants reporting at least 1 AE. There was no significant difference in the frequency of AE between the intervention and placebo arms, except for angiotensin-converting enzyme inhibitors (87.0% [95% CI: 85.0%-88.8%] vs 82.0% [95% CI: 79.8%-84.0%], absolute difference: +5% with intervention; P < 0.001). There was no significant difference in drug discontinuation because of AE between placebo and intervention arms in angiotensin-converting enzyme inhibitors, mineralocorticoid receptor antagonists, sodium glucose cotransporter 2 inhibitors, or angiotensin receptor neprilysin inhibitor/angiotensin II receptor blocker trials. Patients randomized to beta-blocker were significantly less likely to stop study drug because of AE than placebo (11.3% [95% CI: 10.3%-12.3%] vs 13.7% [95% CI: 12.5%-14.9%], absolute difference: -1.1%; P = 0.015). When individual types of AE were assessed, the initiation of an intervention vs placebo resulted in small differences in absolute frequency of AE that were largely not statistically significant.ConclusionsIn clinical trials of GDMT for HFrEF, AEs are observed frequently. However, rates of AE are similar between active medication and control, suggesting these may reflect the high risk nature of the heart failure disease state rather than be attributive to a specific therapy.

Project description:To assess the tolerability of initiating/uptitrating sacubitril/valsartan (LCZ696) from 50 to 200 mg twice daily (target dose) over 3 and 6 weeks in heart failure (HF) patients (ejection fraction ?35%).A 5-day open-label run-in (sacubitril/valsartan 50 mg twice daily) preceded an 11-week, double-blind, randomization period [100 mg twice daily for 2 weeks followed by 200 mg twice daily ('condensed' regimen) vs. 50 mg twice daily for 2 weeks, 100 mg twice daily for 3 weeks, followed by 200 mg twice daily ('conservative' regimen)]. Patients were stratified by pre-study dose of angiotensin-converting enzyme inhibitor/angiotensin-receptor blocker (ACEI/ARB; low-dose stratum included ACEI/ARB-naïve patients). Of 540 patients entering run-in, 498 (92%) were randomized and 429 (86.1% of randomized) completed the study. Pre-defined tolerability criteria were hypotension, renal dysfunction and hyperkalaemia; and adjudicated angioedema, which occurred in ('condensed' vs. 'conservative') 9.7% vs. 8.4% (P = 0.570), 7.3% vs. 7.6% (P = 0.990), 7.7% vs. 4.4% (P = 0.114), and 0.0% vs. 0.8% of patients, respectively. Corresponding proportions for pre-defined systolic blood pressure <95 mmHg, serum potassium >5.5 mmol/L, and serum creatinine >3.0 mg/dL were 8.9% vs. 5.2% (P = 0.102), 7.3% vs. 4.0% (P = 0.097), and 0.4% vs. 0%, respectively. In total, 378 (76%) patients achieved and maintained sacubitril/valsartan 200 mg twice daily without dose interruption/down-titration over 12 weeks (77.8% vs. 84.3% for 'condensed' vs. 'conservative'; P = 0.078). Rates by ACEI/ARB pre-study dose stratification were 82.6% vs. 83.8% (P = 0.783) for high-dose/'condensed' vs. high-dose/'conservative' and 84.9% vs. 73.6% (P = 0.030) for low-dose/'conservative' vs. low-dose/'condensed'.Initiation/uptitration of sacubitril/valsartan from 50 to 200 mg twice daily over 3 or 6 weeks had a tolerability profile in line with other HF treatments. More gradual initiation/uptitration maximized attainment of target dose in the low-dose ACEI/ARB group.

Dataset Information

A Novel Intelligent Two-Way Communication System for Remote Heart Failure Medication Uptitration (the CardioCoach Study): Randomized Controlled Feasibility Trial.

Publications

A Novel Intelligent Two-Way Communication System for Remote Heart Failure Medication Uptitration (the CardioCoach Study): Randomized Controlled Feasibility Trial.

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