Remote management of heart failure using implantable electronic devices A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices. Optimising self-care support for people with heart failure and their caregivers: development of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention using intervention mapping Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial Use of Remote Monitoring to Improve Outcomes in Patients with Heart Failure: A Pilot Trial Telemedical Interventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design. Home telemonitoring of vital signs and cardiorespiratory signals in heart failure patients: system architecture and feasibility of the HHH model. Device monitoring strategies in acute heart failure syndromes Automated home telephone self-monitoring reduces hospitalization in patients with advanced heart failure "I am not alone": the feasibility and acceptability of interactive voice response-facilitated telephone peer support among older adults with heart failure. Cost of medical services in older patients with heart failure: those receiving enhanced monitoring using a computer-based telephonic monitoring system compared with those in usual care: the Heart Failure Home Care trial. Impact of Home Patient Telemonitoring on Use of β-Blockers in Congestive Heart Failure Assessment of a primary care-based telemonitoring intervention for home care patients with heart failure and chronic lung disease. The TELBIL study Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial A telephone-delivered empowerment intervention with patients diagnosed with heart failure. Lack of improvement of clinical outcomes by a low-cost, hospital-based heart failure management programme Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial [Noninvasive remote telemonitoring for ambulatory patients with heart failure: effect on number of hospitalizations, days in hospital, and quality of life. CARME (CAtalan Remote Management Evaluation) study]. Education and telephone monitoring by nurses of patients with heart failure: randomized clinical trial. Association of Discharge Summary Quality With Readmission Risk for Patients Hospitalized With Heart Failure Exacerbation Heart Failure 2012
Abstract Aims Remote management of heart failure using implantable electronic devices ( REM-HF ) aim ed to assess the clinical and cost-effectiveness of remote monitoring ( RM ) of heart failure in patients with cardiac implanted electronic devices ( CIEDs ) . Methods and results Between 29 September 2011 and 31 March 2014 , we r and omly assigned 1650 patients with heart failure and a CIED to active RM or usual care ( UC ) . The active RM pathway included formalized remote follow-up protocol s , and UC was st and ard practice in nine recruiting centres in Engl and . The primary endpoint in the time to event analysis was the 1st event of death from any cause or unplanned hospitalization for cardiovascular reasons . Secondary endpoints included death from any cause , death from cardiovascular reasons , death from cardiovascular reasons and unplanned cardiovascular hospitalization , unplanned cardiovascular hospitalization , and unplanned hospitalization . REM-HF is registered with IS RCT N ( 96536028 ) . The mean age of the population was 70 years ( range 23–98 ) ; 86 % were male . Patients were followed for a median of 2.8 years ( range 0–4.3 years ) completing on 31 January 2016 . Patient adherence was high with a drop out of 4.3 % over the course of the study . The incidence of the primary endpoint did not differ significantly between active RM and UC groups , which occurred in 42.4 and 40.8 % of patients , respectively [ hazard ratio 1.01 ; 95 % confidence interval ( CI ) 0.87–1.18 ; P = 0.87 ] . There were no significant differences between the two groups with respect to any of the secondary endpoints or the time to the primary endpoint components . Conclusion Among patients with heart failure and a CIED , RM using weekly downloads and a formalized follow up approach does not improve outcomes 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 aim ed at improved medication management and adherence may improve HF management and reduce readmissions . Objective The primary goal of this r and omized 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 r and omized 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 question naires at enrollment and closeout to gather data on medication adherence , health status , and HRQoL. Electronic medical records were review ed 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 st and alone 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 Clinical Trials.gov NCT01814696 ; https:// clinical trials.gov/ct2/show/ study /NCT01814696 ( Archived by WebCite ® at http://www.webcitation.org/6giqAVhno AIMS Only limited comparative data exist on the benefits of fluid monitoring ( FM ) combined with remote monitoring ( RM ) regarding morbidity and mortality of heart failure ( HF ) patients . This prospect i ve single-centre r and omized pilot study aim ed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality . METHODS AND RESULTS Patients with st and ard indication for implantable cardioverter defibrillator ( ICD ) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM , and were followed for 15 months . Subjects were r and omly allocated to RM including OptiVol and predefined management of alerts ( remote group ) , or st and ard in-office visits every 3 months ( control group ) . A total of 176 patients ( 77 % male ; 66 ± 12 years ; left ventricular ejection fraction ( LVEF ) 32 ± 11 % ; ischemic cardiomyopathy 50 % ; CRT device 50 % ; primary prevention 85 % ) were analysed . Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [ 0.62 - 2.44 ] ( P = 0.551 ) favouring the control group . In the remote group , 13 patients ( 15 % ) experienced ICD shocks vs. 10 patients ( 11 % ) in the control group ( P = 0.512 ) . The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm ( P = 0.994 ) . The Kaplan-Meier estimate of mortality after 1 year was 8.6 % ( eight deaths ) in the remote group vs. 4.6 % in the control group ( six deaths ; P = 0.502 ) . CONCLUSION In a single-centre r and omized pilot study of RM in combination with FM , no significant influence on HF-related hospitalizations , ICD shocks , or mortality was found Background We aim ed to establish the support needs of people with heart failure and their caregivers and develop an intervention to improve their health-related quality of life . Methods We used intervention mapping to guide the development of our intervention . We identified “ targets for change ” by synthesis ing research evidence and international guidelines and consulting with patients , caregivers and health service providers . We then used behaviour change theory , expert opinion and a taxonomy of behaviour change techniques , to identify barriers to and facilitators of change and to match intervention strategies to each target . A patient and public involvement group helped to identify patient and caregiver needs , refine the intervention objectives and strategies and deliver training to the intervention facilitators . A feasibility study ( IS RCT N25032672 ) involving 23 patients , 12 caregivers and seven trained facilitators at four sites assessed the feasibility and acceptability of the intervention and quality of delivery and generated ideas to help refine the intervention . Results The Rehabilitation Enablement in Chronic Heart Failure ( REACH-HF ) intervention is a comprehensive self-care support programme comprising the “ Heart Failure Manual ” , a choice of two exercise programmes for patients , a “ Family and Friends Re source ” for caregivers , a “ Progress Tracker ” tool and a facilitator training course . The main targets for change are engaging in exercise training , monitoring for symptom deterioration , managing stress and anxiety , managing medications and underst and ing heart failure . Secondary targets include managing low mood and smoking cessation . The intervention is facilitated by trained healthcare professionals with specialist cardiac experience over 12 weeks , via home and telephone contacts . The feasibility study found high levels of satisfaction and engagement with the intervention from facilitators , patients and caregivers . Intervention fidelity analysis and stakeholder feedback suggested that there was room for improvement in several areas , especially in terms of addressing caregivers ’ needs . The REACH-HF material s were revised accordingly . Conclusions We have developed a comprehensive , evidence -informed , theoretically driven self-care and rehabilitation intervention that is grounded in the needs of patients and caregivers . A r and omised controlled trial is underway to assess the effectiveness and cost-effectiveness of the REACH-HF intervention in people with heart failure and their caregivers IMPORTANCE It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure ( HF ) after hospitalization . OBJECTIVE To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF . DESIGN , SETTING , AND PARTICIPANTS We r and omized 1437 patients hospitalized for HF between October 12 , 2011 , and September 30 , 2013 , to the intervention arm ( 715 patients ) or to the usual care arm ( 722 patients ) of the Better Effectiveness After Transition-Heart Failure ( BEAT-HF ) study and observed them for 180 days . The date s of our study analysis were March 30 , 2014 , to October 1 , 2015 . The setting was 6 academic medical centers in California . Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF . INTERVENTIONS The intervention combined health coaching telephone calls and telemonitoring . Telemonitoring used electronic equipment that collected daily information about blood pressure , heart rate , symptoms , and weight . Central ized registered nurses conducted telemonitoring review s , protocol ized actions , and telephone calls . MAIN OUTCOMES AND MEASURES The primary outcome was readmission for any cause within 180 days after discharge . Secondary outcomes were all-cause readmission within 30 days , all-cause mortality at 30 and 180 days , and quality of life at 30 and 180 days . RESULTS Among 1437 participants , the median age was 73 years . Overall , 46.2 % ( 664 of 1437 ) were female , and 22.0 % ( 316 of 1437 ) were African American . The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge , which occurred in 50.8 % ( 363 of 715 ) and 49.2 % ( 355 of 722 ) of patients , respectively ( adjusted hazard ratio , 1.03 ; 95 % CI , 0.88 - 1.20 ; P = .74 ) . In secondary analyses , there were no significant differences in 30-day readmission or 180-day mortality , but there was a significant difference in 180-day quality of life between the intervention and usual care groups . No adverse events were reported . CONCLUSIONS AND RELEVANCE Among patients hospitalized for HF , combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01360203 Background Heart failure is a prevalent health problem associated with costly hospital readmissions . Transitional care programs have been shown to reduce readmissions but are costly to implement . Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed . The objective of this r and omized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight , blood pressure , heart rate , and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure . Methods / Design A multi-center , r and omized controlled trial is being conducted at six academic health systems in California . A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure . Patients in the intervention group will receive intensive patient education using the ‘ teach-back ’ method and receive instruction in using the telemonitoring equipment . Following hospital discharge , they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a central ized call center . The nurses also will call patients and patients ’ physicians in response to alerts generated by the telemonitoring system , based on predetermined parameters . The primary outcome is readmission for any cause within 180 days . Secondary outcomes include 30-day readmission , mortality , hospital days , emergency department ( ED ) visits , hospital cost , and health-related quality of life . Discussion BEAT-HF is one of the largest r and omized controlled trials of telemonitoring in patients with heart failure , and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring . The study population also includes patients with a wide range of demographic and socioeconomic characteristics . Once completed , the study will be a rich re source of information on how best to use remote technology in the care management of patients with chronic heart failure . Trial registration Clinical Trials.gov # NCT01360203 Remote monitoring ( RM ) of homebound heart failure ( HF ) patients has previously been shown to reduce hospital admissions . We conducted a pilot trial of ambulatory , non-homebound patients recently hospitalized for HF to determine whether RM could be successfully implemented in the ambulatory setting . Eligible patients from Massachusetts General Hospital ( n = 150 ) were r and omized to a control group ( n = 68 ) or to a group that was offered RM ( n = 82 ) . The participants transmitted vital signs data to a nurse who coordinated care with the physician over the course of the 6-month study . Participants in the RM program had a lower all-cause per person readmission rate ( mean = 0.64 , SD ± 0.87 ) compared to the usual care group ( mean = 0.73 , SD ± 1.51 ; P-value = .75 ) although the difference was not statistically significant . HF-related readmission rate was similarly reduced in participants . This pilot study demonstrates that RM can be successfully implemented in non-homebound HF patients and may reduce readmission rates AIMS Remote patient management ( telemonitoring ) may help to detect early signs of cardiac decompensation , allowing optimization of and adherence to treatments in chronic heart failure ( CHF ) . Two meta-analyses have suggested that telemedicine in CHF can reduce mortality by 30 - 35 % . The aim of the TIM-HF study was to investigate the impact of telemedical management on mortality in ambulatory CHF patients . Methods CHF patients [ New York Heart Association ( NYHA ) II/III , left ventricular ejection fraction (LVEF)≤35 % ] with a history of cardiac decompensation with hospitalization in the past or therapy with intravenous diuretics in the prior 24 months ( no decompensation required if LVEF≤25 % ) were r and omized 1:1 to an intervention group of daily remote device monitoring ( electrocardiogram , blood pressure , body weight ) coupled with medical telephone support or to usual care led by the patients ' local physician . In the intervention group , 24/7 physician-led medical support was provided by two central telemedical centres . A clinical event committee blinded to treatment allocation assessed cause of death and reason for hospitalization . The primary endpoint was total mortality . The first secondary endpoint was a composite of cardiovascular mortality or hospitalization due to heart failure . Other secondary endpoints included cardiovascular mortality , all-cause and cause-specific hospitalizations ( all time to first event ) as well as days lost due to heart failure hospitalization or cardiovascular death ( in % of follow-up time ) , and changes in quality of life and NYHA class . Overall , 710 CHF patients were recruited . The mean follow-up was 21.5±7.2 months , with a minimum of 12 months . Perspective The study will provide important prospect i ve outcome data on the impact of telemedical management in patients with CHF BACKGROUND The Home or Hospital in Heart Failure Study ( HHH ) is a European Community funded trial ( QLGA-CT-2001 - 02424 ) which compares usual care of heart failure ( HF ) with three home-based interventions in a multicenter , multicountry ( Italy , Pol and and UK ) , r and omized controlled clinical trial . Home telemonitoring ( HT ) of clinical parameters represents a potential alternative ( or addition ) to traditional home care models . Nocturnal respiratory disorders ( periodic breathing , sleep apnea ) are very common in HF , and are associated with increased morbidity and mortality . We developed an integrated HT system for monitoring of both vital signs and respiration . All measurements were patient-managed . This paper describes the architecture of this system , and assesses its feasibility . METHODS AND RESULTS 461 clinical ly stable patients were r and omized first to usual vs home-monitored care ; the latter were further r and omized to 3 strategies . Over a 12-month follow-up 2 of these 3 groups ( 195 patients , age : 60+/-11 years , NYHA class II-III : 97 % , LVEF 28+/-7 % ) underwent self-administered home monitoring of vital signs ( weekly--12 parameters using an interactive voice response system ) and respiration ( monthly--24-hour recording ) . Data were transmitted over conventional telephone lines ; 81 % of actually practicable vital signs measurements were completed by the patients ( range : 75 % (PL)-93 % ( UK ) ) , as well as 92 % of practicable respiratory recordings ( range : 85 % (PL)-99 % ( UK ) ) . 87 % of nighttime recordings were eligible for the study ( good quality signals for > or = 2.5 h ) . CONCLUSIONS This study , the largest so far , demonstrates that self-managed home telemonitoring of both vital signs and respiration is feasible in HF patients , with surprisingly high compliance . We found an excellent rate of acceptable nocturnal respiratory recordings , which are those with the greatest clinical relevance Acute heart failure syndromes ( AHFS ) represent the most common discharge diagnoses in adults over age 65 and translate into dramatically increased heart failure – associated morbidity and mortality . Conventional approaches to the early detection of pulmonary and systemic congestion have been shown to be of limited sensitivity . Despite their proven efficacy , disease management and structured telephone support programs have failed to achieve widespread use in part due to their re source intensiveness and reliance upon motivated patients . While once thought to hold great promise , results from recent prospect i ve studies on telemonitoring strategies have proven disappointing . Implantable devices with their capacity to monitor electrophysiologic and hemodynamic parameters over long periods of time and with minimal reliance on patient participation may provide solutions to some of these problems . Conventional electrophysiologic parameters and intrathoracic impedance data are currently available in the growing population of heart failure patients with equipped devices . A variety of implantable hemodynamic monitors are currently under investigation . How best to integrate these devices into a systematic approach to the management of patients before , during , and after AHFS  is yet to be established We studied 138 patients admitted for heart failure ( HF ) . Patients were allocated one of three treatment strategies . Group 1 ( G1 , n = 50 ) were given usual care for HF , Group 2 ( G2 , n = 56 ) received a multi-disciplinary team approach , while Group 3 ( G3 , n = 32 ) had home telephone self-monitoring . Telemonitoring was based on the answers to three simple queries about bodyweight change , dyspnoea and general health . The system stratified the HF severity of each patient once a week , and recommended a prompt medical appointment or simple follow-up . Over a 12-month follow-up period , there were 43 adverse events ( cardiovascular deaths and rehospitalizations for HF : G1 = 22 , G2 = 14 , G3 = 7 ) . There was no difference between G2 and G3 ( P = 0.78 ) but there was significant disadvantage with usual care ( P = 0.02 vs. G2 and P = 0.04 vs. G3 ) . Time to re-admission for HF increased in G2 and G3 compared to G1 ( 188 and 198 days vs. 95 days , P = 0.03 and P = 0.02 respectively ) . Automated home telephone self-monitoring reduced rehospitalization in patients with advanced HF Patient self-management is a critical determinant of heart failure ( HF ) outcomes , yet patients with HF are often frail and socially isolated , factors that may limit their ability to manage self-care and access clinic-based services . Mobilizing peer support among HF patients is a promising strategy to improve self-management support . In this pilot , the authors evaluated the feasibility and acceptability of an interactive voice response (IVR)-based platform to facilitate telephone peer support among older adults with HF . Participants completed a baseline survey , were offered a 3-hour training session in peer communication skills , and were paired with another patient who had HF . Participants were asked to contact their partner weekly using a toll-free IVR phone system that protected their anonymity and provided automated reminders if contacts were not made . Times and duration of participants ' telephone contacts were monitored and recorded . After the 7-week intervention , participants completed surveys and brief face-to-face interviews . The authors found high levels of use and satisfaction and improvements in depressive symptoms among the 20 pilot study participants . An IVR peer-support intervention is feasible , is acceptable to patients , and may have positive effects on patients '  HF social support and health outcomes , in conjunction with structured health system support , that warrant more rigorous evaluation in a r and omized trial BACKGROUND Prior studies suggest that disease management programs may be effective in improving clinical and economic outcomes in patients with heart failure . Whether these types of programs can lower health care cost and be adapted to the primary care setting is unknown . This study was design ed to assess the impact of a home-based disease management program , the Alere DayLink HF Monitoring System ( HFMS ) , on the clinical and economic outcomes of Medicare beneficiaries recently hospitalized for heart failure who received the care from a community-based primary care practitioner . METHODS AND RESULTS The Heart Failure Home Care trial was a multicenter , r and omized , controlled trial of sophisticated , monitoring of heart failure patients with an interactive program versus st and ard heart failure care with enhanced patient education and follow-up ( SC ) in Medicare-eligible patients . The study endpoints included cardiovascular death or rehospitalization for heart failure , length of hospital stay , total patient cost , and cost to Medicare at 6 months of enrollment . A total of 315 patients age ≥ 65 years old were r and omized : 160 to the HFMS and 155 to SC . There were no significant statistical differences between the groups in regards to 6-month cardiac mortality , rehospitalizations for heart failure , or length of hospital stay . Of those , 304 patients had their Medicare data available . The information from the Medicare cl aims data was used to determine the cost . Information from the trial was used to determine costs of out-patient drugs and the interventions . The 6-month mean Medicare costs were estimated to be $ 17,837 and $ 13,886 for the HFMS and the SC groups , respectively . We found that overall medical costs of medicare patients were significantly higher for patients who were r and omized to the HFMS arm than they were for the patients r and omized to the SC arm . CONCLUSIONS Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program and less costly in patients who are elderly and receive the care from a community-based primary care practitioner Abstract Introduction Congestive heart failure ( CHF ) , which typically affects older people , is characterized by high short- and mid-term mortality rates . However , despite accumulating evidence showing that administration of β-blockers ( β-adrenoceptor antagonists ) can improve the clinical status of CHF patients , use of these agents in adequate dosages in this setting is not routine . One reason for this appears to be a concern about a possible risk of bradyarrhythmia associated with use of β-blockers . Telecardiology has recently been investigated as a means of constantly monitoring the heart rate of CHF patients in their homes . Its use may allay concerns about the risk of bradyarrhythmia and facilitate a more widespread use of β-blockers in this context . Objectives The primary objectives of this study were to assess the impact of telemonitoring on patients ’ adherence to prescribed therapeutic regimens , particularly β-blockers , and to explore whether use of home telemonitoring reduces mortality and rate of re-admission to hospital in elderly CHF patients compared with normal specialized CHF team care . Methods A total of 57 patients with CHF ( 31 New York Heart Association [ NYHA ] class II , 23 NYHA class III and 3 NYHA class IV ) , with a mean ±SD age of 78.2±7.3 years , were r and omized to a control group who received st and ard care  , based on routinely scheduled clinic visits , from a team specialized in CHF patient management , or to a home telemonitoring group ( TM group )  , managed by the same specialized CHF team . Patients were followed up over 12 months . Results Compared with the control group , the TM group had a significant increase in the use of β-blockers , HMG-CoA reductase inhibitors ( statins ) and aldosterone receptor antagonists . A reduction in nitrate administration compared with baseline was also seen in the TM group . The 12-month occurrence of the primary combined endpoint of mortality and hospital re-admission for CHF was significantly lower in the TM group than in the control group ( p < 0.01 ) . Conclusions This study showed that a home-care model including telemonitoring of relevant clinical parameters may provide useful support in the management of patients with CHF . Home telemonitoring in CHF patients was associated with increased use of β-blockers at appropriate doses , suggesting that this strategy reassured physicians regarding the safety of careful use of these agents in this setting . However , larger studies are required to confirm these findings . Our findings indicate that there is a need to investigate relevant parameters in CHF patients at the point of care ( i.e. in patients ’ daily lives ) , which can in turn optimize β-blocker and other drug therapy Background Telemonitoring technology offers one of the most promising alternatives for the provision of health care services at the patient 's home . The primary aim of this study is to evaluate the impact of a primary care-based telemonitoring intervention on the frequency of hospital admissions . Methods / design A primary care-based r and omised controlled trial will be carried out to assess the impact of a telemonitoring intervention aim ed at home care patients with heart failure ( HF ) and /or chronic lung disease ( CLD ) . The results will be compared with those obtained with st and ard health care practice . The duration of the study will be of one year . Sixty patients will be recruited for the study . In-home patients , diagnosed with HF and /or CLD , aged 14 or above and with two or more hospital admissions in the previous year will be eligible . For the intervention group , telemonitoring will consist of daily patient self- measurements of respiratory-rate , heart-rate , blood pressure , oxygen saturation , weight and body temperature . Additionally , the patients will complete a qualitative symptom question naire daily using the telemonitoring system . Routine telephone contacts will be conducted every fortnight and additional telephone contacts will be carried out if the data received at the primary care centre are out of the established limits . The control group will receive usual care . The primary outcome measure is the number of hospital admissions due to any cause that occurred in a period of 12 months post-r and omisation . The secondary outcome measures are : duration of hospital stay , hospital admissions due to HF or CLD , mortality rate , use of health care re sources , quality of life , cost-effectiveness , compliance and patient and health care professional satisfaction with the new technology . Discussion The results of this study will shed some light on the effects of telemonitoring for the follow-up and management of chronic patients from a primary care setting . The study may contribute to enhance the underst and ing of alternative modes of health care provision for medically unstable elderly patients , who bear a high degree of physical and functional deterioration . Trial Registration IS RCT N : IS RCT 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 r and omized , controlled clinical intervention trial design ed 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 Netherl and s , will be approached for study participation and r and omly assigned ( 1:1 ) following blocked r and omization 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 underst and ing 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 numberNCT01347528 BACKGROUND Heart failure ( HF ) is a major public health problem . Case management by nurses using telephone follow-up has been suggested as a convenient and effective mechanism to promote the self-management of HF . Similarly , a patient empowerment approach to the management of chronic disease has been suggested as one that may nurture self-management in individuals with chronic illness . OBJECTIVE The purpose of this study was to examine the effects of a telephone-delivered empowerment intervention ( EI ) on clinical ly and theoretically relevant outcomes in patients with HF , including purpose ful participation in goal attainment , self-management of HF , and perception of functional health . The EI was guided by Rogers ' Science of Unitary Human Beings person-environment process . METHODS A convenience sample of men and women aged 21 years and older with a clinical diagnosis of HF was obtained from a metropolitan hospital located in the southwestern United States . The participants were r and omly assigned to the control group ( n = 45 ) or EI group ( n = 45 ) . All participants received st and ardized HF patient education ; the intervention group also received an EI delivered through telephone follow-up calls from a registered nurse . Repeated- measures analysis of variance was used to evaluate intervention effects . RESULTS The telephone-delivered EI  facilitated self-management of HF through self-care activities in EI group members . CONCLUSION The knowledge gained from this study provides a beginning underst and ing of strategies to enhance health care providers ' ability to facilitate self-management of HF among patients diagnosed with HF Objective Heart failure ( HF ) is a major health problem result ing in a high financial burden for the healthcare system . Many previous HF management programmes reduced adverse clinical outcomes and costs , but they usually involved several professional figures as well as huge investments , requiring re sources and budgets not often available in our healthcare system . We evaluated the effects of our HF management programme , which included patient education and regular outpatient contact with the HF team , on re-hospitalisation and death , optimising the few re sources already available at our hospital . Methods Two hundred consecutive patients admitted to the internal medicine department with a diagnosis of HF were r and omised to the intervention group ( nurse-led education programme , facilitated telephone communication and follow-up visits with an internist at 15 days , 1 and 6 months ) or to the usual care group ( follow-up by their primary care physician ) . The primary endpoints were all-cause readmissions and all-cause deaths during the 6-month post-discharge period . Results There were 81 all-cause hospital readmissions in the intervention group and 82 in the control group ( P = NS ) . Fourteen patients ( 14 % ) in the intervention group and eight patients ( 8 % ) in the control group died during the study period ( P = NS ) . Unplanned outpatient visits were less frequent in the intervention group than in the control group ( 39 [ 28 % ] versus 99 [ 72 % ] , P < 0.001 ) . Conclusions The present low-cost HF management programme reduced unplanned outpatient visits but proved ineffective in reducing subsequent readmissions and in improving clinical status . More intense follow-up monitoring and more re sources are needed to achieve better results Background Patients with recent stroke or TIA are at high risk for new vascular events . Several evidence based strategies in secondary prevention of stroke are available but frequently underused . Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospect i ve controlled trials so far . INSPiRE-TMS is a prospect i ve , multi-center , r and omized open intervention trial for intensified secondary prevention after minor stroke and TIA . Methods / design Patients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay . Patients are r and omised in a 1:1 ratio to intervention ( support program ) and control ( usual care ) arms . Inclusion of 2.082 patients is planned . The support program includes cardiovascular risk factor measurement and feedback , monitoring of medication adherence , coaching in lifestyle modifications , and active involvement of relatives . St and ardized motivational interviewing is used to assess and enhance patients ’ motivation . Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infa rct ion or vascular death . Recruitment time is planned for 3.5 years , follow up time is at least 2 years for every patient result ing in a total study time of 5 years ( first patient in to last patient out ) . Discussion Given the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention , the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time . The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care . A cost-effectiveness evaluation will be performed . Trial registration clinical trials.gov : INTRODUCTION AND OBJECTIVES Multidisciplinary strategies for the management of heart failure ( HF ) improve outcomes . We aim ed to evaluate the effectiveness of noninvasive home telemonitoring in ambulatory patients with HF already included in a structured multidisciplinary HF program . METHODS Prospect i ve intervention study with before/after comparison design of an interactive telemedicine platform in HF patients , r and omized 1:1 into two groups : A ) Motiva System with educational videos , motivational messages , and question naires , and B ) Motiva System + self monitoring of blood pressure , heart rate , and weight . Hospitalizations were compared over 12 months prior to and post study inclusion . Quality of life was evaluated using the generic EuroQoL visual analogue scale and the specific question naire Minnesota Living With Heart Failure Question naire . RESULTS There were 92 patients included ( 71 % male ; 66.3 ± 11.5 years ; 71 % ischemic aetiology ) . During real-time telemonitoring over 11.8 months ( interquartile range 8.6 - 12 ) , 14,730 question naires were administered with 89 % median response rate . Hospitalizations for HF decreased by 67.8 % ( P = .010 ) and for other cardiac causes by 57.6 % ( P = .028 ) . The number of days in hospital for HF decreased by 73.3 % ( P = .036 ) , without statistically significant differences between groups , and for other cardiac causes by 82.9 % ( P = .008 ) . The perception of quality of life improved significantly both for the generic scale ( P < .001 ) and for the HF specific question naire ( P=.005 ) . CONCLUSIONS HF patients who used an interactive telehealth system with motivational support tools at home spent less time in hospital and felt their quality of life had significantly improved . No significant differences were observed between groups BACKGROUND Nursing approaches to manage patients with heart failure ( HF ) showed benefits in reducing the morbidity and mortality . However , combining intra-hospital education with telephone contact after hospital discharge has been little explored . OBJECTIVE To compare two nursing intervention groups among patients hospitalized due to decompensated HF : the intervention group ( IG ) received educational nursing intervention during hospitalization followed by telephone monitoring after discharge and the  control group  ( CG ) received in-hospital intervention only . Outcomes were levels of HF and self-care knowledge , the frequency of visits to the emergency room , rehospitalizations and deaths in a three-month period . METHODS R and omized clinical trial . We studied adult HF patients with left ventricle ejection fraction ( LVEF ) < 45 % who could be contacted by telephone after discharge .  HF awareness was evaluated through a st and ardized question naire that also included questions regarding self-care knowledge , which was answered during the hospitalization period and three months later . For patients in the IG group contacts were made using phone calls and final interviews were conducted in both groups at end of the study . RESULTS Forty-eight patients were assigned to the IG and 63 to the CG . Mean age ( 63 ± 13 years ) and L ( around 29 % ) were similar in the two groups . Scores for HF and self-care knowledge were similar at baseline . Three months later , both groups showed significantly improved HF awareness and self-care knowledge scores ( P < 0.001 ) . Other outcomes were similar . CONCLUSION An in-hospital educational nursing intervention benefitted all HF patients in underst and ing their disease , regardless of telephone contact after discharge Patients admitted with heart failure have disproportionately high readmission rates , most recently ranging from 17.5 % to 30.3 % nationally.1 The Affordable Care Act penalizes hospitals with higher than average readmission rates after admissions for heart failure . However , clinicians remain uncertain , which strategies are associated with reducing readmissions in this population .2 Experts have proposed that the creation and transmission of a high- quality discharge summary to outpatient clinicians may improve the transition from hospital to home . Discharge summaries may facilitate safer transitions in care by informing outpatient clinicians about the course of hospitalization , identifying pending studies requiring follow-up , suggesting further follow-up testing , and clarifying changes in medications and treatments after discharge . Nonetheless , despite widespread enthusiasm for improving the quality of discharge summaries , there have been few studies of the effectiveness of discharge summaries in helping to avoid readmissions , and those few have found no association of timeliness,3,4 transmission,5,6 or content5 with readmission . To determine the association of discharge quality and readmission in a large national sample , we examined discharge summaries of patients enrolled in the Telemonitoring to Improve Heart Failure Outcomes ( Tele-HF ) r and omized controlled trial . # # # Study Cohort and Setting The  Tele-HF study included patients living at home and hospitalized for heart failure in the previous 30 days.7 Patients in Tele-HF were recruited from 33 cardiology practice s in 21 states and the District of Columbia . We obtained discharge summaries for the index hospitalization . Wherever possible , we obtained Heart failure has been named “ the growing epidemic . ” Over the last decade , the annual number of heart failure hospitalizations has almost doubled with approximately 50 % of patients being rehospitalized within 6 months of discharge [ 1 ] . The complex array of physiologic , psychological , social , and health care delivery issues makes it a challenging chronic disease to manage . Underst and ing the epidemiology and pathophysiology of the syndrome , identifying the predictors and their strength of association with outcomes , and using the available diagnostic modalities cost-effectively are essential in order to devise effective prevention interventions and implement novel therapeutic approaches to curb this epidemic . In this special issue , we have invited a few papers that address such issues and explain why despite the emergence of novel therapeutic approaches , that promise life prolongation and hospital length reduction , this patient population will still be needing rehospitalization and will often have a poor prognosis . This special issue is the extension of an effort that was initiated in 2011 with the first heart-failure-focused issue [ 2 ] . In the pathophysiology section , S. M. R. Kazemi-Bajestani et al. describe the opportunities and challenges of targeting the angiotensin converting enzyme 2 (ACE2)/Ang II/Ang1–7 and apelin/APJ pathways as novel therapeutic modalities in heart failure [ 3 ] . ACE2 and the apelin/APJ are two important peptide systems which exert diverse effects on the cardiovascular system . Dysregulation of such systems may be involved in the predisposition to cardiovascular diseases whereas enhancing their action may have important therapeutic effects . In the same section , D. Lindner et al. provide a comprehensive review on the protective function of signal transducer and activator of transcription 3 ( STAT3 ) in CVB3-induced myocarditis [ 4 ] . The transcription factor ( STAT3 ) is an important mediator of the inflammatory process , and in this original research the investigators examine the role of STAT3 in viral myocarditis and its possible role in the development to dilated cardiomyopathy . Considering the high mortality rate and the availability of life-saving therapies like transplantation and left ventricular assist devices , accurate prognosis determination in HF is clinical ly important . Taking into account the mediocre performance of current established prediction models , such as the Seattle Heart Failure Model [ 5–7 ] , the work by H. Fukuta et al. [ 8 ] on the prognostic value of left ventricular diastolic dysfunction in patients undergoing cardiac catheterization for coronary artery disease sheds light on this extremely important topic . A shared underst and ing of medical conditions between patients and their health care providers has been shown to improve self-care and outcomes [ 9 ] . In the comorbidity section , we demonstrate how certain comorbid conditions may affect patients ' decision-making capacity and interfere with their ability to comply with treatment requirements , recognize and self-manage disease worsening symptoms . Among others , cognitive impairment is increasingly recognized as a common adverse consequence of HF , whereby phenomena such as microembolism , chronic or intermittent cerebral hypoperfusion , and /or impaired cerebral vessel reactivity may lead to cerebral hypoxia and ischemic brain damage . Cognitive decline in HF is characterized by deficits in one or more cognition domains , including attention , memory , executive function , and psychomotor speed . E. Dardiotis et al. [ 10 ] , in a comprehensive review , underscore the importance for healthcare professionals to become familiar with assessment of cognitive performance using st and ardized screening instruments in their routine evaluations of HF patients . Another comorbidity gaining increasing attention in HF patients is depression . There are several pathophysiological mechanisms as well as behavioral processes linking depression and HF . Equally important is screening for depression and there are several valid and reliable screening tools to identify patients at greater risk . Consultation should be provided by a multidisciplinary team , consisting of cardiologists , psychiatrists , and hospital or community nurses so as to carefully plan , execute , and evaluate medical intervention and implement lifestyle changes . D. Mastrogiannis et al. [ 11 ] systematic ally review the existing knowledge regarding current definitions , prognostic implication s , pathophysiological mechanisms , and current and future treatment options in patients with depression and HF . Evidence from the literature supports the possibility of a pathophysiological relationship between cognitive impairment , depression , and HF . Yet , very few studies have sought to investigate this relationship . The paper by Z. N. Sohani and Z. Samaan review s current literature on the association between depression and cognitive impairment  in persons with HF and explores possible mechanisms explaining this complex triad [ 12 ] . Heart failure through neurohumoral activation induces alterations of cardiac metabolism , such as insulin resistance , and promotes increased utilization of noncarbohydrate substrates for energy production [ 13 , 14 ] . Fasting blood ketone bodies as well as fat oxidation have been shown to be increased in this patient population . The result is depletion of myocardial ATP , phosphocreatine , and creatine kinase , leading to decreased efficiency of mechanical work . A direct approach to manipulate cardiac energy metabolism consists in modifying substrate utilization by the failing heart . Trimetazidine , perhexiline , and ranolazine directly inhibit fatty acid oxidation and have been used to increase the ischemic threshold in patients with effort angina . Current research is supporting the concept that shifting the energy substrate preference away from fatty acid metabolism and toward glucose metabolism could be an effective adjunctive treatment in patients with HF . These agents have been shown to improve both glucose metabolism and left ventricular function in diabetic patients with left ventricular dysfunction . In the pharmacotherapy section , we provide a systematic review , in which N. Signoretta et al. [ 15 ] discuss the beneficial therapeutic effects of modulation of cardiac metabolic substrates utilization in patients with HF . In the advanced heart failure section , we provide a thorough review on the current status of mechanical circulatory support in patients with advanced HF . Management of the advanced HF patients with the numerous comorbidities [ 16 , 17 ] requires a significant amount of health care re sources and is becoming a major public health problem . As therapeutical strategies for HF have been refined , the number of patients suffering from the end-stage disease has exp and ed dramatically . Although heart transplantation still represents the gold st and ard therapeutical approach , the shortage of donors universally has made the implantation of mechanical circulatory support devices a well-established management for this disease . The systematic review by K. Spiliopoulos et al. [ 18 ] , outlines the current status of mechanical circulatory support in this patient population . In the chronic follow-up section , we deal with telemonitoring , a novel diagnostic modality that has been suggested to be beneficial for HF patients , targeting optimization of their chronic followup . Telemonitoring is viewed as a means of recording physiological data ( such as body weight , heart rate , arterial blood pressure electrocardiogram recordings , and other data ) by portable devices and transmitting these data remotely ( via a telephone line , a mobile phone , or a computer ) to a server where they can be stored , review ed , and analyzed by the research team . In a systematic review of all r and omized clinical trials evaluating telemonitoring in chronic HF , G. Giamouzis et al. [ 19 ] assess whether telemonitoring provides any substantial benefit in this patient population . We hope that the readers of the journal will find the topics as interesting and important as we did . Gregory Giamouzis George Giannakoulas Javed Butler John A. Elefteriades Carsten Tschope Filippos
No favourable effect on mortality was observed with STS HM .
Similar reductions were observed in all-cause hospitalisations for TM interventions , whereas STS interventions had no major effect .
STS HM was dominated by usual care .
Similar results were observed in scenario analyses performed using higher costs of usual care , higher costs of STS HH and lower costs of TM during office hours .
As a result , the economic model developed scenarios for different RM classifications and their costs were estimated using bottom-up costing methods .
Despite wide variation in usual care and RM strategies , cost-effectiveness analyses suggest that TM during office hours was an optimal strategy ( in most costing scenarios ) .
However , clarity was lacking among descriptions of the components of RM packages and usual care and there was a lack of robust estimation of costs .
BACKGROUND Remote monitoring ( RM ) strategies have the potential to deliver specialised care and management to patients with heart failure ( HF ) .
OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of home telemonitoring ( TM ) or structured telephone support ( STS ) strategies compared with usual care for adult patients who have been recently discharged ( within 28 days ) from acute care after a recent exacerbation of HF .
The review included r and omised controlled trials ( RCTs ) or observational cohort studies with a contemporaneous control group that included the following RM interventions : ( 1 ) TM ( including cardiovascular implanted monitoring devices ) with medical support provided during office hours or 24/7 ; ( 2 ) STS programmes delivered by human-to-human contact ( HH ) or human-to-machine interface ( HM ) .