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 A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices. A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact) Assessment of a primary care-based telemonitoring intervention for home care patients with heart failure and chronic lung disease. The TELBIL study 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. Effect of a telemonitoring-facilitated collaboration between general practitioner and heart failure clinic on mortality and rehospitalization rates in severe heart failure: the TEMA-HF 1 (TElemonitoring in the MAnagement of Heart Failure) study. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial Remote management of heart failure using implantable electronic devices Use of Remote Monitoring to Improve Outcomes in Patients with Heart Failure: A Pilot Trial Use of Home Telemonitoring to Support Multidisciplinary Care of Heart Failure Patients in Finland: Randomized Controlled Trial A multicenter randomized controlled evaluation of automated home monitoring and telephonic disease management in patients recently hospitalized for congestive heart failure: the SPAN-CHF II trial. A multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: study protocol for a randomized controlled trial Impact of Remote Telemedical Management on Mortality and Hospitalizations in Ambulatory Patients With Chronic Heart Failure: The Telemedical Interventional Monitoring in Heart Failure Study Telemonitoring with case management for seniors with heart failure. Results of a telehealth-enabled chronic care management service to support people with long-term conditions at home First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure – CardioBBEAT
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 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 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 Background In heart failure ( HF ) patients with implantable cardioverter defibrillators ( ICD ) or cardiac resynchronisation therapy defibrillators ( CRT-D )  , remote monitoring has been shown to result in at least non-inferior outcomes relative to in-clinic visits . We aim ed to provide further evidence for this effect , and to assess whether adding telephone follow-ups to remote follow-ups influenced outcomes . Methods InContact was a prospect i ve , r and omised , multicentre study . Subjects receiving quarterly automated follow-up only ( telemetry group )  were compared to those receiving personal physician contact .  Personal contact patients were further divided into those receiving automated follow-up plus a telephone call ( remote+phone subgroup ) or in-clinic visits only . Results Two hundred and ten patients underwent r and omisation ( telemetry n = 102 ; personal contact n = 108 [ remote+phone : n = 53 ; visit : n = 55 ] ) . Baseline characteristics were comparable between groups and subgroups . Over 12 months , 34.8 % of patients experienced deterioration of their Packer Clinical Composite Response , with no significant difference between the telemetry group and personal care ( p > 0.999 ) , remote+phone ( p = 0.937 ) or visit ( p = 0.940 ) patients ; predefined non-inferiority criteria were met . Mortality rates ( 5.2 % overall ) were comparable between groups and subgroups ( p = 0.832/p = 0.645 ) , as were HF-hospitalisation rates ( 11.0 % overall ; p = 0.605/p = 0.851 ) . The proportion of patients requiring ≥1 unscheduled follow-up was nominally higher in telemetry and remote+phone groups ( 42.2 and 45.3 % ) compared to the visit group ( 29.1 % ) . Overall , ≥ 1 ICD therapy was delivered to 15.2 % of patients . Conclusion In HF patients with ICDs/CRT-Ds , quarterly remote follow-up only over 12 months was non-inferior to regular personal contact . Addition of quarterly telephone follow-ups to remote monitoring does not appear to offer any clinical advantage . Trial registration clinical trials.gov : NCT01200381 ( retrospectively registered on September 13th 2010 ) 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 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 AIMS Chronic heart failure ( CHF ) patients are frequently rehospitalized within 6 months after an episode of fluid retention . Rehospitalizations are preventable , but this requires an extensive organization of the healthcare system . In this study , we tested whether intensive follow-up of patients through a telemonitoring-facilitated collaboration between general practitioners ( GPs ) and a heart failure clinic could reduce mortality and rehospitalization rate . METHODS AND RESULTS One hunderd and sixty CHF patients [ mean age 76 ± 10 years , 104 males , mean left ventricular ejection fraction ( LVEF ) 35 ± 15 % ] were block r and omized by sealed envelopes and assigned to 6 months of intense follow-up facilitated by telemonitoring ( TM ) or usual care ( UC ) . The TM group measured body weight , blood pressure , and heart rate on a daily basis with electronic devices that transferred the data automatically to an online data base . Email alerts were sent to the GP and heart failure clinic to intervene when pre-defined limits were exceeded . All-cause mortality was significantly lower in the TM group as compared with the UC group ( 5 % vs. 17.5 % , P = 0.01 ) . The total number of follow-up days lost to hospitalization , dialysis , or death was significantly lower in the TM group as compared with the UC group ( 13 vs. 30 days , P = 0.02 ) . The number of hospitalizations for heart failure per patient showed a trend ( 0.24 vs. 0.42 hospitalizations/patient , P = 0.06 ) in favour of TM . CONCLUSION Telemonitoring-facilitated collaboration between GPs and a heart failure clinic reduces mortality and number of days lost to hospitalization , death , or dialysis in CHF patients . These findings need confirmation in a large trial BACKGROUND Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation , thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation . We aim ed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population . METHODS The Telemedical Interventional Management in Heart Failure II ( TIM-HF2 ) trial was a prospect i ve , r and omised , controlled , parallel-group , unmasked ( with r and omisation concealment ) , multicentre trial with pragmatic elements introduced for data collection . The trial was done in Germany , and patients were recruited from hospitals and cardiology practice s. Eligible patients had heart failure , were in New York Heart Association class II or III , had been admitted to hospital for heart failure within 12 months before r and omisation , and had a left ventricular ejection fraction ( LVEF ) of 45 % or lower ( or if higher than 45 % , oral diuretics were being prescribed ) . Patients with major depression were excluded . Patients were r and omly assigned ( 1:1 ) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days . The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death , analysed in the full analysis set . Key secondary outcomes were all-cause and cardiovascular mortality . This study is registered with Clinical Trials.gov , number NCT01878630 , and has now been completed . FINDINGS Between Aug 13 , 2013 , and May 12 , 2017 , 1571 patients were r and omly assigned to remote patient management ( n=796 ) or usual care ( n=775 ) . Of these 1571 patients , 765 in the remote patient management group and 773 in the usual care group started their assigned care , and were included in the full analysis set . The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88 % ( 95 % CI 4·55 - 5·23 ) in the remote patient management group and 6·64 % ( 6·19 - 7·13 ) in the usual care group ( ratio 0·80 , 95 % CI 0·65 - 1·00 ; p=0·0460 ) . Patients assigned to remote patient management lost a mean of 17·8 days ( 95 % CI 16·6 - 19·1 ) per year compared with 24·2 days ( 22·6 - 26·0 ) per year for patients assigned to usual care . The all-cause death rate was 7·86 ( 95 % CI 6·14 - 10·10 ) per 100 person-years of follow-up in the remote patient management group compared with 11·34 ( 9·21 - 13·95 ) per 100 person-years of follow-up in the usual care group ( hazard ratio [ HR ] 0·70 , 95 % CI 0·50 - 0·96 ; p=0·0280 ) . Cardiovascular mortality was not significantly different between the two groups ( HR 0·671 , 95 % CI 0·45 - 1·01 ; p=0·0560 ) . INTERPRETATION The TIM-HF2 trial suggests that a structured remote patient management intervention , when used in a well defined heart failure population , could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality . FUNDING German Federal Ministry of Education and Research 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 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 Background Heart failure ( HF ) patients suffer from frequent and repeated hospitalizations , causing a substantial economic burden on society . Hospitalizations can be reduced considerably by better compliance with self-care . Home telemonitoring has the potential to boost patients ’ compliance with self-care , although the results are still contradictory . Objective A r and omized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization . Methods HF patients were eligible whose left ventricular ejection fraction was lower than 35 % , NYHA functional class ≥2 , and who needed regular follow-up . Patients in the telemonitoring group ( n=47 ) measured their body weight , blood pressure , and pulse and answered symptom-related questions on a weekly basis , reporting their values to the heart failure nurse using a mobile phone app . The heart failure nurse followed the status of patients weekly and if necessary contacted the patient . The primary outcome was the number of HF-related hospital days . Control patients ( n=47 ) received multidisciplinary treatment according to st and ard practice s. Patients ’ clinical status , use of health care re sources , adherence , and user experience from the patients ’ and the health care professionals ’ perspective were studied . Results Adherence , calculated as a proportion of weekly su bmi tted self- measurements , was close to 90 % . No difference was found in the number of HF-related hospital days ( incidence rate ratio [IRR]=0.812 , P=.351 ) , which was the primary outcome . The intervention group used more health care re sources : they paid an increased number of visits to the nurse ( IRR=1.73 , P<.001 ) , spent more time at the nurse reception ( mean difference of 48.7 minutes , P<.001 ) , and there was a greater number of telephone contacts between the nurse and intervention patients ( IRR=3.82 , P<.001 for nurse-induced contacts and IRR=1.63 , P=.049 for patient-induced contacts ) . There were no statistically significant differences in patients ’ clinical health status or in their self-care behavior . The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study . Conclusions Home telemonitoring did not reduce the number of patients ’ HF-related hospital days and did not improve the patients ’ clinical condition . Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently , and on this way increased the use of health care re sources . Trial Registration Clinical trials.gov NCT01759368 ; http:// clinical trials.gov/show/NCT01759368 ( Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z ) BACKGROUND We performed a prospect i ve , r and omized investigation assessing the incremental effect of automated health monitoring ( AHM ) technology over and above that of a previously described nurse directed heart failure ( HF ) disease management program . The AHM system measured and transmitted body weight , blood pressure , and heart rate data as well as subjective patient self- assessment s via a st and ard telephone line to a central server . METHODS AND RESULTS A total of 188 consented and eligible patients were r and omized between intervention and control groups in 1:1 ratio . Subjects r and omized to the control arm received the Specialized Primary and Networked Care in Heart Failure ( SPAN-CHF ) heart failure disease management program . Subjects r and omized to the intervention arm received the SPAN-CHF disease management program in conjunction with the AHM system . The primary end point was prespecified as the relative event rate of HF hospitalization between intervention and control groups at 90 days . The relative event rate of HF hospitalization for the intervention group compared with controls was 0.50 ( 95%CI [ 0.25 - 0.99 ] , P = .05 ) . CONCLUSIONS Short-term reductions in the heart failure hospitalization rate were associated with the use of automated home monitoring equipment . Long-term benefits in this model remain to be studied Background Chronic obstructive pulmonary disease ( COPD ) and chronic heart failure ( CHF ) frequently coexist , significantly reducing patients ’ quality of life and increasing morbidity and mortality . For either single disease , a multidisciplinary disease-management approach supported by telecommunication technologies offers the best outcome in terms of prolonged survival and reduced hospital readmissions . However , no data exist in patients with combined COPD /CHF.We planned a r and omized controlled trial to investigate the feasibility and efficacy of an integrated , home-based , medical/nursing intervention plus a rehabilitation program versus conventional care in patients with coexisting COPD /CHF . The purpose of the paper is to describe the rationale and design of the trial . Methods / design s Patients , after inpatient rehabilitation , were r and omly assigned to the intervention or control group , followed for 4 months at home , then assessed at 4 and 6 months . The intervention group followed a telesurveillance ( telephone contacts by nurse and remote monitoring of cardiorespiratory parameters ) and home-based rehabilitation program ( at least three sessions/week of mini-ergometer exercises , callisthenic exercises and twice weekly pedometer-driven walking , plus telephone contacts by a physiotherapist ) . Telephone follow-up served to verify compliance to therapy , maintain exercise motivation , educate for early recognition of signs/symptoms , and verify the skills acquired . At baseline and 4 and 6 months , the 6-min Walk Test , dyspnea and fatigue at rest , oxygenation ( PaO2/FiO2 ) , physical activity profile ( PASE question naire ) , and QoL ( Minnesota and CAT question naires ) were assessed . During the study , serious clinical events ( hospitalizations or deaths ) were recorded . Discussion Currently , no studies have assessed the impact of a telehealth program in patients with combined COPD and CHF . Our study will show whether this approach is effective in the management of such complex , frail patients who are at very high risk of exacerbations . Trial registration Network per la prevenzione e la sanità pubblica , CCM , Ministero della Salute “ Modelli innovativi di gestione integrata telegestita ospedale-territorio del malato cronico a fenotipo complesso : studio di implementazione , validazione e impatto , ” registered on 14 January 2014 . Clinical Trials.gov Identifier : NCT02269618 , registered on 17 October 2014 Background — This study was design ed to determine whether physician-led remote telemedical management ( RTM ) compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure ( HF ) . Methods and Results — We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction ⩽35 % and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction ⩽25 % . Patients were r and omly assigned ( 1:1 ) to RTM or usual care . Remote telemedical management used portable devices for ECG , blood pressure , and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers . The primary end point was death from any cause . The first secondary end point was a composite of cardiovascular death and hospitalization for HF . Baseline characteristics were similar between the RTM ( n=354 ) and control ( n=356 ) groups . Of the patients assigned to RTM , 287 ( 81 % ) were at least 70 % compliant with daily data transfers and no break for > 30 days ( except during hospitalizations ) . The median follow-up was 26 months ( minimum 12 ) , and was 99.9 % complete . Compared with usual care , RTM had no significant effect on all-cause mortality ( hazard ratio , 0.97 ; 95 % confidence interval , 0.67 to 1.41 ; P=0.87 ) or on cardiovascular death or HF hospitalization ( hazard ratio , 0.89 ; 95 % confidence interval , 0.67 to 1.19 ; P=0.44 ) . Conclusions — In ambulatory patients with chronic HF  , RTM compared with usual care was not associated with a reduction in all-cause mortality . Clinical Trial Registration : — URL : http://www . Clinical Trials.gov . Unique identifier : NCT00543881 OBJECTIVE To assess the impact of supplementing nurse case management with Internet-connected telemonitoring on clinical outcomes in an elderly heart failure ( HF ) population . STUDY DESIGN R and omized clinical trial allocating high-risk HF subjects to the telehealth system with case management ( THCM ) versus case management ( CM ) alone . METHODS Medicare Advantage members with HF and recent hospitalization were r and omized to THCM or CM . Consenting participants received THCM for 6 months or the health plan 's usual Medicare specialized CM as long as deemed necessary . The primary outcome measure was a composite of all-cause hospitalization , ED visit , or death . Because only a subset of those who were r and omized consented and participated , the strategies were evaluated as-treated rather than by intention-to-treat , with multivariate adjustment in logistic regression models for confounding introduced by postr and omization exclusions . RESULTS The treated sample size was 164 subjects in THCM and 152 in CM . Treatment arms did not differ significantly for the primary composite outcome ( 45 % for THCM vs 40 % for CM , relative risk 1.18 ; P = .22 ) . Telehealth alerts prompted frequent telephonic contact , increasing THCM case managers ' workload . The participant population overall had 42 % fewer inpatient days during the intervention period compared with the previous year . CONCLUSIONS Despite effective implementation of an Internet-based telehealth intervention in an elderly HF population , there was no discernible impact on overall morbidity or mortality . Notably , limited postr and omization participation decreased power to detect a difference . The reduction in days hospitalized for trial participants overall underscores the benefit of CM for such HF patients Both congestive heart failure and chronic obstructive pulmonary disease are more common among Māori than non-Māori people , and the cultural acceptability of home-based remote monitoring technology has not been tested . We conducted a 12-month pilot trial of home telemonitoring .  Patients were r and omly assigned to the control and intervention groups . Patients in the control group showed no clear differences in quality of life at the end of the trial . The telehealth group showed a consistent trend towards improved quality of life on several instruments , including the SF-36 , the St George Respiratory Question naire and the K10 question naire ; the improvement in the latter was significant . Hospitalizations were reduced in both the control ( −19 % ) and telehealth group ( −25 % ) . Patient interviews indicated that the technology was acceptable to most patients and their families , including the Māori . The results from the pilot trial suggest that wider implementation with a cost benefit evaluation could be worthwhile Background Evidence that home telemonitoring for patients with chronic heart failure ( CHF ) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage . Methods Between January 2010 and June 2013 , patients with a confirmed diagnosis of CHF were enrolled and r and omly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system ( Motiva ® ) . The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio ( ICER ) established by the groups ’ difference in total cost and in the combined clinical endpoint “ days alive and not in hospital nor inpatient care per potential days in study ” within the follow-up of 12 months . Results A total of 621 predominantly male patients were enrolled , whereof 302 patients were assigned to the intervention group and 319 to the control group .  Ischemic cardiomyopathy was the leading cause of heart failure . Despite r and omization , subjects of the control group were more often in NYHA functional class III – IV , and exhibited peripheral edema and renal dysfunction more often . Additionally , the control and intervention groups differed in heart rhythm disorders . No differences existed regarding risk factor profile , comorbidities , echocardiographic parameters , especially left ventricular and diastolic diameter and ejection fraction , as well as functional test results , medication and quality of life . While the observed baseline differences may well be a play of chance , they are of clinical relevance . Therefore , the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances . Conclusions CardioBBEAT provides prospect i ve outcome data on both , clinical and health economic impact of home telemonitoring in CHF . The study differs by the use of a high evidence level r and omized controlled trial ( RCT ) design along with actual cost data obtained from health insurance companies . Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care . Overall , it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System . Trial registration Clinical Trials.gov NCT02293252 ; date of registration : 10 November
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 ) .