INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact) 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 Adherence, adaptation and acceptance of elderly chronic heart failure patients to receiving healthcare via telephone-monitoring. Patient Engagement With a Mobile Web-Based Telemonitoring System for Heart Failure Self-Management: A Pilot Study A randomized trial of home telemonitoring in a typical elderly heart failure population in North West London: results of the Home-HF study. Effect of Home-Based Telemonitoring Using Mobile Phone Technology on the Outcome of Heart Failure Patients After an Episode of Acute Decompensation: Randomized Controlled Trial Results of a telehealth-enabled chronic care management service to support people with long-term conditions at home Mobile Phone-Based Telemonitoring for Heart Failure Management: A Randomized Controlled Trial Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study Impact of telemonitoring at home on the management of elderly patients with congestive heart failure Use of Home Telemonitoring to Support Multidisciplinary Care of Heart Failure Patients in Finland: Randomized Controlled Trial Remote monitoring of patients with biventricular defibrillators through the CareLink system improves clinical management of arrhythmias and heart failure episodes Remote management of heart failure using implantable electronic devices Evaluation of home telehealth following hospitalization for heart failure: a randomized trial. Randomized Trial of Telephone Intervention in Chronic Heart Failure (DIAL): study design and preliminary observations. 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.
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 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 BACKGROUND Although the potential to reduce hospitalisation and mortality in chronic heart failure ( CHF ) is well reported , the feasibility of receiving healthcare by structured telephone support or telemonitoring is not . AIMS To determine ; adherence , adaptation and acceptability to a national nurse-coordinated telephone-monitoring CHF management strategy . The Chronic Heart Failure Assistance by Telephone Study ( CHAT ) . METHODS Triangulation of descriptive statistics , feedback surveys and qualitative analysis of clinical notes . Cohort comprised of st and ard care plus intervention ( SC+I ) participants who completed the first year of the study . RESULTS 30 GPs ( 70 % rural ) r and omised to SC+I recruited 79 eligible participants , of whom 60 ( 76 % ) completed the full 12 month follow-up period . During this time 3619 calls were made into the CHAT system ( mean 45.81 SD+/-79.26 , range 0 - 369 ) , Overall there was an adherence to the study protocol of 65.8 % ( 95 % CI 0.54 - 0.75 ; p=0.001 ) however , of the 60 participants who completed the 12 month follow-up period the adherence was significantly higher at 92.3 % ( 95 % CI 0.82 - 0.97 , p < or=0.001 ) . Only 3 % of this elderly group ( mean age 74.7+/-9.3 years ) were unable to learn or competently use the technology . Participants rated CHAT with a total acceptability rate of 76.45 % . CONCLUSION This study shows that elderly CHF patients can adapt quickly , find telephone-monitoring an acceptable part of their healthcare routine , and are able to maintain good adherence for a least 12 months Background Intensive remote monitoring programs for congestive heart failure have been successful in reducing costly readmissions , but may not be appropriate for all patients . There is an opportunity to leverage the increasing accessibility of mobile technologies and consumer-facing digital devices to empower patients in monitoring their own health outside of the hospital setting . The iGetBetter system , a secure Web- and telephone-based heart failure remote monitoring program , which leverages mobile technology and portable digital devices , offers a creative solution at lower cost . Objective The objective of this pilot study was to evaluate the feasibility of using the iGetBetter system for disease self-management in patients with heart failure . Methods This was a single-arm prospect i ve study in which 21 ambulatory , adult heart failure patients used the  intervention for heart failure self-management over a 90-day study period . Patients were instructed to take their weight , blood pressure , and heart rate measurements each morning using a WS-30 bluetooth weight scale , a self-inflating blood pressure cuff ( Withings LLC , Issy les Moulineaux , France ) , and an iPad Mini tablet computer ( Apple Inc , Cupertino , CA , USA ) equipped with cellular Internet connectivity to view their measurements on the Internet . Outcomes assessed included usability and satisfaction , engagement with the intervention , hospital re source utilization , and heart failure-related quality of life . Descriptive statistics were used to summarize data , and matched controls identified from the electronic medical record were used as comparison for evaluating hospitalizations . Results There were 20 participants ( mean age 53 years ) that completed the study . Almost all participants ( 19/20 , 95 % ) reported feeling more connected to their health care team and more confident in performing care plan activities , and 18/20 ( 90 % ) felt better prepared to start discussion s about their health with their doctor . Although heart failure-related quality of life improved from baseline , it was not statistically significant ( P=.55 ) . Over half of the participants had greater than 80 % ( 72/90 days ) weekly and overall engagement with the program , and 15 % ( 3/20 ) used the interactive voice response telephone system exclusively for managing their care plan . Hospital utilization did not differ in the intervention group compared to the control group ( planned hospitalizations P=.23 , and unplanned hospitalizations P=.99 ) . Intervention participants recorded shorter average length of hospital stay , but no significant differences were observed between intervention and control groups ( P=.30 ) . Conclusions This pilot study demonstrated the feasibility of a low-intensive remote monitoring program leveraging commonly used mobile and portable consumer devices in augmenting care for a fairly young population of ambulatory patients with heart failure . Further prospect i ve studies with a larger sample size and within more diverse patient population s is necessary to determine the effect of mobile-based remote monitoring programs such as the iGetBetter system on clinical outcomes in heart failure AIMS Heart failure chiefly affects the elderly , with frequent emergency admissions . Telemonitoring can identify worsening heart failure but previous r and omized trials have enrolled selected patient population s. The Home-HF study examined the impact of home telemonitoring on typical heart failure patients discharged from three acute hospitals in North West London , UK . METHODS AND RESULTS Patients hospitalized with heart failure were r and omized to telemonitoring or usual specialist care . Primary outcome measures were days alive and out of hospital . Secondary outcome measures were number and duration of heart failure hospitalizations , clinic visits , and quality of life .  We recruited 182 patients . There was no difference in the primary outcome measure in the two groups , but there were significantly fewer unplanned hospitalizations for heart failure decompensation , and a reduction in clinic and emergency room visits in the telemonitoring group . There was no statistically significant difference in the mean direct health service costs . CONCLUSION Home telemonitoring in a typical elderly population of heart failure patients produces a similar outcome to ' usual ' specialist care , but reduces clinic and emergency room visits and unplanned heart failure rehospitalizations at little additional cost . This method of disease monitoring may allow specialist services to increase the number of patients under their care Background Telemonitoring of patients with chronic heart failure ( CHF ) is an emerging concept to detect early warning signs of impending acute decompensation in order to prevent hospitalization . Objective The goal of the MOBIle TELemonitoring in Heart Failure Patients Study ( MOBITEL ) was to evaluate the impact of home-based telemonitoring using Internet and mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation . Methods Patients were r and omly allocated to pharmacological treatment ( control group ) or to pharmacological treatment with telemedical surveillance for 6 months ( tele group ) . Patients r and omized into the tele group were equipped with mobile phone – based patient terminals for data acquisition and data transmission to the monitoring center . Study physicians had continuous access to the data via a secure Web portal . If transmitted values went outside individually adjustable borders , study physicians were sent an email alert . Primary endpoint was hospitalization for worsening CHF or death from cardiovascular cause . Results The study was stopped after r and omization of 120 patients ( 85 male , 35 female ) ; median age was 66 years ( IQR 62 - 72 ) . The control group comprised 54 patients ( 39 male , 15 female ) with a median age of 67 years ( IQR 61 - 72 ) , and the tele group included 54 patients ( 40 male , 14 female ) with a median age of 65 years ( IQR 62 - 72 ) . There was no significant difference between groups with regard to baseline characteristics . Twelve tele group patients were unable to begin data transmission due to the inability of these patients to properly operate the mobile phone ( “ never beginners ” ) . Four patients did not finish the study due to personal reasons . Intention-to-treat analysis at study end indicated that 18 control group patients ( 33 % ) reached the primary endpoint ( 1 death , 17 hospitalizations ) , compared with 11 tele group patients ( 17 % , 0 deaths , 11 hospitalizations ; relative risk reduction 50 % , 95 % CI 3 - 74 % , P = .06 ) . Per- protocol analysis revealed that 15 % of tele group patients ( 0 deaths , 8 hospitalizations ) reached the primary endpoint ( relative risk reduction 54 % , 95 % CI 7 - 79 % , P= .04 ) . NYHA class improved by one class in tele group patients only ( P < .001 ) . Tele group patients who were hospitalized for worsening heart failure during the study had a significantly shorter length of stay ( median 6.5 days , IQR 5.5 - 8.3 ) compared with control group patients ( median 10.0 days , IQR 7.0 - 13.0 ; P= .04 ) . The event rate of never beginners was not higher than the event rate of control group patients . Conclusions Telemonitoring using mobile phones as patient terminals has the potential to reduce frequency and duration of heart failure hospitalizations . Providing elderly patients with an adequate user interface for daily data acquisition remains a challenging component of such a concept 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 Previous trials of telemonitoring for heart failure management have reported inconsistent results , largely due to diverse intervention and study design s. Mobile phones are becoming ubiquitous and economical , but the feasibility and efficacy of a mobile phone-based telemonitoring system have not been determined . Objective The objective of this trial was to investigate the effects of a mobile phone-based telemonitoring system on heart failure management and outcomes . Methods One hundred patients were recruited from a heart function clinic and r and omized into telemonitoring and control groups . The telemonitoring group ( N = 50 ) took daily weight and blood pressure readings and weekly single-lead ECGs , and answered daily symptom questions on a mobile phone over 6 months . Readings were automatically transmitted wirelessly to the mobile phone and then to data servers . Instructions were sent to the patients ’ mobile phones and alerts to a cardiologist ’s mobile phone as required . Results Baseline question naires were completed and returned by 94 patients , and 84 patients returned post- study question naires . About 70 % of telemonitoring patients completed at least 80 % of their possible daily readings . The change in quality of life from baseline to post- study , as measured with the Minnesota Living with Heart Failure Question naire , was significantly greater for the telemonitoring group compared to the control group ( P = .05 ) . A between-group analysis also found greater post- study self-care maintenance ( measured with the Self-Care of Heart Failure Index ) for the telemonitoring group ( P = .03 ) . Brain natriuretic peptide ( BNP ) levels , self-care management , and left ventricular ejection fraction ( LVEF ) improved significantly for both groups from baseline to post- study , but did not show a between-group difference . However , a subgroup within-group analysis using the data from the 63 patients who had attended the heart function clinic for more than 6 months revealed the telemonitoring group had significant improvements from baseline to post- study in BNP ( decreased by 150 pg/mL , P = .02 ) , LVEF ( increased by 7.4 % , P = .005 ) and self-care maintenance ( increased by 7 points , P = .05 ) and management ( increased by 14 points , P = .03 ) , while the control group did not . No differences were found between the telemonitoring and control groups in terms of hospitalization , mortality , or emergency department visits , but the trial was underpowered to detect differences in these metrics . Conclusions Our findings provide evidence of improved quality of life through improved self-care and clinical management from a mobile phone-based telemonitoring system . The use of the mobile phone-based system had high adherence and was  feasible for patients , including the elderly and those with no experience with mobile phones . Trial Registration Clinical Trials.gov 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 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 We studied the effects of home telemonitoring in elderly patients with congestive heart failure ( CHF ) on mortality and rate of hospitalization , compliance with treatment , quality of life and costs of CHF management , by comparison with a group receiving usual care . Fifty-seven elderly CHF patients were r and omized to st and ard care or to home telemonitoring-based care  and followed for 12 months . In the subjects who were monitored , weekly reports on their clinical status were obtained and their management was modified accordingly . Home telemonitoring was associated with improvements in the composite endpoint of mortality and rate of hospitalizations ( P = 0.006 ) , a better compliance with therapy , more frequent use of beta-blockers and statins , lower total cholesterol level and a better reported health perception score . The improved results with home telemonitoring in CHF were probably due to better compliance and to closer monitoring of the patients 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 ) Purpose The aim of the present study is to evaluate if remote monitoring with the CareLink Network may improve clinical management of tachyarrhythmias and heart failure episodes in patients treated with biventricular defibrillators ( CRT-D ) .  Methods Patients implanted with CRT-D for more than 6 months received the CareLink monitor and were trained to perform device interrogation . At-home transmissions were scheduled at 2 weeks , 1 and 2 months after training , with a final in-office visit after 3 months . Results Sixty-seven patients performed 264 data transmissions . Twenty-three unscheduled data transmissions were requested by the centers after patient contact . Ventricular tachyarrhythmias were reported in nine patients during 16 data review s. Thirteen data review s ( 81 % ) were performed remotely via CareLink transmissions ( nine scheduled and four unscheduled ) , in seven patients . Of these events , in two cases ( 15 % ) in-hospital visits were requested , while in 11 ( 85 % ) no action was needed and no additional in-clinic visits were scheduled . During the study period , in 20/28 ( 71 % ) intra-thoracic impedance alerts , the patients remotely transmitted their device data . After remote data review , in ten cases drug therapy was adjusted by phone and in four cases no action was needed and the patient reassured . In six episodes an in-hospital extra visit was scheduled . On the whole , in 14 cases ( 70 % ) , the patient could be managed remotely avoiding a visit to the hospital . Conclusions Our study showed that remote follow-up is an efficient method to manage tachyarrhythmias and heart failure episodes in  CRT-D patients . Early reaction to clinical events may improve overall patient care 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 Previous studies have found that home-based intervention programs reduce readmission rates for patients with heart failure . Only one previous trial has compared telephone and videophone to traditional care to deliver a home-based heart failure intervention program . The objective of this study was to evaluate the efficacy of a telehealth-facilitated postdischarge support program in reducing re source use in patients with heart failure . Patients at a Midwestern Department of Veterans Affairs Medical Center were r and omized to telephone , videophone , or usual care for follow-up care after hospitalization for heart failure exacerbation . Outcome measures included readmission rates ; time to first readmission ; urgent care clinic visits ; survival ; and quality of life . The intervention result ed in a significantly longer time to readmission but had no effect on readmission rates or mortality . There were no differences in hospital days or urgent care clinic use . All subjects reported higher disease-specific quality of life scores at 1 year . There was evidence of the value of telephone follow-up , but there was no evidence to support the benefit of videophone care over telephone care . Rigorous evaluation is needed to determine which patients may benefit most from specific telehealth applications and which technologies are most cost-effective BACKGROUND In the last few years different approaches based on comprehensive patient care and close surveillance by multidisciplinary teams have shown promising results in heart failure . However , current evidence mainly derives from small and often nonr and omized studies performed at a single center , with selected population s , using dissimilar and complex strategies . We design ed a large r and omized study to test the hypothesis that a single program , based on a central ized telephone intervention performed by trained nurses , could reduce morbidity and mortality in chronic heart failure . METHODS The R and omized Trial of Telephone Intervention in Chronic Heart Failure ( DIAL ) is a r and omized , controlled , open trial design ed to compare frequent telephone follow-up intervention versus control . We enrolled 1518 patients with stable chronic heart failure and optimal treatment from 51 centers in Argentina . DIAL trial intervention strategy is based on frequent telephone follow-up provided by nurses trained in heart failure and performed from a single surveillance center , assuring a homogeneous and high quality intervention . The primary objective is to determine the effect of the intervention as compared with the usual follow-up on the combined endpoint of all-cause mortality or hospitalization for worsening heart failure . The objectives of the intervention are  education , counseling , and monitoring to enhance self-control mechanisms , timely medical visits , diet , and drug therapy compliance . Telephone call frequency was determined according to preestablished criteria of clinical status severity assessed at each phone contact . The study ended in August 2002 . CONCLUSION The results of this study may provide information about mortality , hospitalizations , and quality of life contributing to set st and ards for management programs in the current treatment of chronic heart failure 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
Conclusion : Despite a systematic bias towards recruitment of individuals younger than the epidemiological average into the r and omized controlled trials , older people with heart failure did benefit from structured telephone support and telemonitoring .
While further research is required to confirm these observational findings , the evidence at h and indicates that discrimination by age alone may be not be appropriate when inviting participation in a remote monitoring service for heart failure
Background : There are few data regarding the effectiveness of remote monitoring for older people with heart failure .
We conducted a post-hoc sub- analysis of a previously published large Cochrane systematic review and meta- analysis of relevant r and omized controlled trials to determine whether structured telephone support and telemonitoring were effective in this population .