Remote management of heart failure using implantable electronic devices The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design. The effect of mere measurement from a cardiovascular examination program on physical activity and sedentary time in an adult population Gender differences in response to a physical activity intervention in overweight and obese children. Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up: The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) Trial Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial. Defibrillator shocks and their effect on objective and subjective patient outcomes: Results of the PainFree SST clinical trial. The Impact of Web-Based Feedback on Physical Activity and Cardiovascular Health of Nurses Working in a Cardiovascular Setting: A Randomized Trial
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 With the advent of remote monitoring , current models of implantable cardioverter defibrillators ( ICDs ) have the possibility of sending automatic alert messages that allow early diagnosis of events such as lung fluid overload , atrial fibrillation and device integrity issues . Timely treatment of these events has the potential to improve patient outcome , but this has not as yet been proven . METHODS The MORE-CARE study is a multicenter r and omized controlled trial evaluating the efficacy of advanced device diagnostics and remote monitoring in improving the outcome of patients with biventricular ICDs . Up to 1720 patients with a st and ard indication for a biventricular ICD will be r and omized to st and ard in-office follow-up , or to a remote monitoring strategy using the CareLink network and involving automatic alerts for lung fluid overload , atrial fibrillation , and device integrity issues . The first phase aims at evaluating the delay between an alert event , and clinical action to the event . The second phase of the study will evaluate whether the remote monitoring strategy results in a significant reduction of a combined end point of total mortality or cardiovascular and device-related hospitalization . The duration of the study will be event-driven due to its sequential design . CONCLUSION MORE-CARE will evaluate the efficacy of remote monitoring for improving patient outcome in patients implanted with a biventricular ICD Background Measuring physical activity ( PA ) and sedentary time ( ST ) by self-report or device as well as assessing related health factors may alter those behaviors . Thus , in intervention trials assessment s may bias intervention effects . The aim of our study was to examine whether leisure-time PA , transport-related PA , and overall ST measured via self-report vary after assessment s and whether a brief tailored letter intervention has an additional effect . Methods Among a sample of subjects with no history of myocardial infa rct ion , stroke , or vascular intervention , a number of 175 individuals participated in a study comprising multiple repeated assessment s. Of those , 153 were analyzed ( mean age 54.5 years , st and ard deviation = 6.2 ; 64 % women ) . At baseline , participants attended a cardiovascular examination ( st and ardized measurement of blood pressure and waist circumference , blood sample taking ) and wore an accelerometer for seven days . At baseline and after 1 , 6 , and 12 months , participants completed the International Physical Activity Question naire . A r and om sub sample received a tailored counseling letter intervention at month 1 , 3 , and 4 . Changes in PA and ST from baseline to 12-month follow-up were analyzed using r and om-effects modelling . Results From baseline to 1-month assessment , leisure-time PA did not change ( Incidence rate ratio = 1.13 , p = .432 ) , transport-related PA increased ( Incidence rate ratio = 1.45 , p = .023 ) , and overall ST tended to decrease ( b = − 1.96 , p = .060 ) . Further , overall ST decreased from month 6 to month 12 ( b = − 0.52 , p = .037 ) . Time trends of the intervention group did not differ significantly from those of the assessment -only group . Conclusions Results suggest an effect of measurements on PA and ST . Data of r and om-effects modelling results revealed an increase of transport-related PA after baseline to 1-month assessment . Decreases in overall ST may result from repeated assessment s. A brief tailored letter intervention seemed to have no additional effect . Thus , measurement effects should be considered when planning intervention studies and interpreting intervention effects . Trial registration Clinical Trials.gov NCT02990039 . Registered 7 December 2016 . Retrospectively registered BACKGROUND This study evaluated the effects of gender on response to a behavioral intervention that rewarded increases in  physical activity ( PA ) with increases in access to TV viewing . METHODS We performed a secondary analysis of a clinical trial that r and omized 30 overweight or obese , 8- to 12-year-old children to an intervention ( 8 boys , 6 girls ) or control ( 7 boys , 9 girls ) group . Participants wore accelerometers every day for 8 weeks and attended biweekly meetings to download the activity monitors . For the intervention group , accumulating 400 counts of PA on accelerometers earned 1 hour of TV time , which was controlled by a Token TV electronic device . Controls wore activity monitors but had free access to TV . RESULTS Compared with girls , boys in the intervention group exhibited greater increases in overall daily PA counts ( 110 % versus 40 % , P < .05 ) and minutes per day of moderate-to-vigorous physical activity ( MVPA ; + 18.1 versus + 2.7 , P < .05 ) . Neither boys nor girls in the control group showed significant changes in overall PA or intensity of PA . CONCLUSION Wearing an accelerometer in combination with rewarding PA with TV might be a more effective intervention for increasing overall PA and time spent in MVPA in overweight and obese boys than it is for overweight or obese girls Background — Monitoring implantable cardiac device function and patient condition is important . The Lumos-T Safely Reduces Routine Office Device Follow-Up ( TRUST ) trial tested the hypothesis that remote home monitoring with automatic daily surveillance ( HM ) is safe and effective for implantable cardioverter-defibrillator follow-up for 1 year and enables rapid physician evaluation of significant events . Methods and Results — In total , 1339 patients were r and omized 2:1 to HM or conventional follow-up . Follow-up checks occurred at 3 , 6 , 9 , 12 , and 15 months after implantation . HM was used before office visits at 3 and 15 months in the HM group . At 6 , 9 , and 12 months , HM only was used but was followed by office visits if necessary . Conventional patients were evaluated with office visits only . Scheduled office visits and unscheduled evaluations , incidence of morbidity , and time elapsed from first event occurrence in each patient to physician evaluation were tracked for each group .  HM and conventional patients were similar ( age , 63.3±12.8 versus 64.0±12.1 years ; gender , 72.0 % versus 73.1 % male ; New York Heart Association class II , 55.9 % versus 60.4 % ; pathology : left ventricular ejection fraction , 29.0±10.7 % versus 28.5±9.8 % ; coronary artery disease , 64.8 % versus 71.7 % ; primary prevention indication , 72.2 % versus 73.8 % ; and dual-chamber implants , 57.8 % versus 56.6 % ) . HM  reduced total in-hospital device evaluations by 45 % without affecting morbidity . In the HM group , 85.8 % of all 6- , 9- , and 12-month follow-ups were performed remotely only , indicating that HM provided sufficient assessment in the majority . Median time to evaluation was < 2 days in the HM group compared with 36 days in the conventional group ( P<0.001 ) for all arrhythmic events . Conclusions — HM is safe and allows more rapid detection of actionable events compared with conventional monitoring in patients with implantable electronic cardiac devices . Clinical Trials Registration — URL : http:/www . clinical trials.gov . Unique identifier : NCT00336284 INTRODUCTION Remote monitoring is increasingly becoming the new st and ard of care for implantable cardioverter defibrillator ( ICD ) follow-up . We sought to determine whether remote monitoring of ICDs improves patient outcomes compared with quarterly device interrogations in clinic . METHODS AND RESULTS In this single-center pilot clinical trial , adult patients with an ICD were r and omly assigned to remote monitoring versus quarterly device interrogations in clinic . The primary endpoint was a composite of cardiovascular hospitalization , emergency room visit for a cardiac cause , and unscheduled visit to the electrophysiology clinic for a device-related issue at 1 year . We also examined health-related quality of life , costs , and patient satisfaction with their ICD care . Of 151 patients enrolled in this trial , 76 were r and omized to remote monitoring and 75 to quarterly device  interrogations in clinic . There was no significant difference in the primary endpoint ( 32 % in the remote monitoring arm vs 34 % in the control arm ; P = 0.8 ) , mortality , or cost between the 2 arms . Quality of life and patient satisfaction were significantly better in the control arm than in the remote monitoring arm at 6 months ( 83 [ 25th , 75th percentiles 70 , 90 ] vs 75 [ 50 , 85 ] ; P = 0.002 and 88 [ 75 , 100 ] vs 75 [ 75 , 88 ] ; P = 0.03 , respectively ) , but not at 12 months . CONCLUSION We showed no significant reduction in cardiac-related re source utilization with remote monitoring of ICDs . However , given the small number of patients in our study , the real clinical and health economics impact of remote monitoring needs to be verified by a large , multicenter , r and omized clinical trial BACKGROUND The effect of  implantable cardioverter-defibrillator ( ICD ) shock  on device-measured activity and patient-reported outcomes is unknown . OBJECTIVE The purpose of this study was to analyze the acute and long-term effects of ICD shock on objective behavioral data ( ie , device-based physical activity ) and subjective patient-reported outcomes ( eg , quality of life and shock anxiety ) . METHODS The PainFree Smart Shock Technology ( SST ) clinical trial included 2770 patients with a single- or dual-chamber ICD or cardiac resynchronization therapy - defibrillator device who were followed for 22 ± 9 months . Participants completed measures of quality of life ( EuroQol-5D [ EQ-5D ] question naire ) and shock anxiety ( Florida Shock Anxiety Scale ) at baseline , biannual visits , and monthly for 6 months after an ICD shock . Daily physical activity data were obtained from a built-in device accelerometer . RESULTS The average daily activity was 185.3 ± 119.4 min/d . Activity was significantly reduced after an ICD shock ( P < .0001 ) and recovered to a normal level after ∼90 days . An ICD shock was also associated with decreased quality of life ( EQ5-D health score ) and increased EQ-5D anxiety scores , but it did not affect mobility , self-care , activity , or pain . Similarly , shock anxiety ( Florida Shock Anxiety Scale ) increased in shocked patients and remained significantly elevated at 24 months , regardless of appropriate or inappropriate shock delivery . CONCLUSION ICD shocks have a long-lasting adverse effect on both objective , device-measured physical activity and subjective patient-reported outcomes of quality of life and shock anxiety . Successful management of patients with an ICD requires attention to clinical ly relevant behavioral and psychological outcomes to expedite recovery and return to activities of daily living A disconcerting proportion of Canadian nurses are physically inactive and report poor cardiovascular health . Web-based interventions incorporating feedback and group features may represent opportune , convenient , and cost-effective methods for encouraging physical activity ( PA ) in order to improve the levels of PA and cardiovascular health of nurses . The purpose of this parallel-group r and omized trial was to examine the impact of an intervention providing participants with feedback from an activity monitor coupled with a web-based individual , friend or team PA challenge , on the PA and cardiovascular health of nurses working in a cardiovascular setting . Methods : Nurses were r and omly assigned in a 1:1:1 ratio to one of the following intervention “ challenge ” groups : ( 1 ) individual , ( 2 ) friend or ( 3 ) team . Nurses wore a Tractivity ® activity monitor throughout a baseline week and 6-week intervention . Height , body mass , body fat percentage , waist circumference , resting blood pressure ( BP ) and heart rate were assessed , and body mass index ( BMI ) was calculated , during baseline and within 1 week post-intervention . Data were analyzed using descriptive statistics and general linear model procedures for repeated measures . Results : 76 nurses ( 97 % female ; age : 46 ± 11 years ) participated . Weekly moderate-to-vigorous intensity PA ( MVPA ) changed over time ( F = 4.022 , df = 4.827 , p = 0.002 , η2 = 0.055 ) , and was greater during intervention week 2 when compared to intervention week 6 ( p = 0.011 ) . Daily steps changed over time ( F = 7.668 , df = 3.910 , p < 0.001 , η2 = 0.100 ) , and were greater during baseline and intervention weeks 1 , 2 , 3 , and 5 when compared to intervention week 6 ( p < 0.05 ) . No differences in weekly MVPA or daily steps were observed between groups ( p > 0.05 ) . No changes in body mass , BMI or waist circumference were observed within or between groups ( p > 0.05 ) . Decreases in body fat percentage ( −0.8 ± 4.8 % , p = 0.015 ) and resting systolic BP ( −2.6 ± 8.8 mmHg , p = 0.019 ) were observed within groups , but not between groups ( p > 0.05 ) . Conclusions : A web-based intervention providing feedback and a PA challenge initially impacted the PA , body fat percentage and resting systolic BP of nurses working in a cardiovascular setting , though increases in PA were short-lived . The nature of the PA challenge did not differentially impact outcomes . Alternative innovative strategies to improve and sustain  nurses ' PA  should be developed and their effectiveness evaluated
CONCLUSIONS Current evidence suggests that D-PA may be useful for assessing physical activity and predicting clinical outcomes in patients with cardiovascular implantable electronic devices when combined with other device parameters .
BACKGROUND  Physical activity  is predictive of cardiovascular outcomes in patients with cardiovascular implantable electronic devices , yet it is not regularly assessed in routine care .
Current-generation cardiovascular implantable electronic devices , however , continuously monitor patient activity through a built-in accelerometer , which provides new opportunities to remotely assess patient activity , detect changes in clinical status , and incorporate these data in risk stratification models .
This review critically examines the literature on device-measured physical activity ( D-PA ) , with a focus on identifying method ological issues that may affect interpretation of study results .