Remote Wireless Telemonitoring Combined with Health Coaching (Tele-Hc) to Lower Readmission Rates for Patients with Acute Decompensated Heart Failure

BackgroundChronic heart failure (HF) is characterized by frequent hospitalization, suboptimal self-care and high readmission rates. Remote telemonitoring (TM) combined with health coaching (HC) has the potential to favorably impact drivers of HF readmission including communication, care coordination, self-care, social support and lifestyle choices.HypothesisRemote TM combined with HC will decrease readmission rates for patients with acute decompensated heart failure (ADHF).MethodsThe Tele-HC multicenter trial will randomize 304 subjects with ADHF prior to hospital dismissal to either standard management including HC versus management facilitated by combined remote TM and HC. Subjects with either HF with reduced ejection fraction or HF with preserved ejection fraction will be enrolled. Subjects will have been stabilized during hospitalization for ADHF at time of discharge. The BodyGuardian® remote TM platform (FDA 510k approved for non-lethal arrhythmia monitoring) will be deployed for those subjects randomized to TM. The BodyGuardian® platform is comprised of a front-end, external, removable, wireless sensor-patch linked to cell-phone technology for transmission of remotely acquired physiologic signals to the Cloud with download to a back-end 24/7 monitoring center which supports automated EKG rhythm classification, as well as heart rate, blood pressure, weight, activity and respiration monitoring including data summary, analysis and communication to the electronic health record and providers. The remote TM platform also enables individualized programming of alert thresholds to facilitate communication between providers and patients. Subjects randomized to TM will wear the remote TM sensor-patch continuously for 60 days. These subjects will also receive the HC service provided by the C3 Nexus High Touch system, which will be integrated with the remote TM platform. The primary endpoint of the Tele-HC trial will be the readmission frequency at 60 days subsequent to hospital dismissal for ADHF. The primary analysis will be a Cochran-Mantel-Haenszel Chi-square test to compare the 60-day readmission rates between the two interventions while controlling for enrolling hospital site. The overall study duration will be two years with subject enrollment over an interval of 1.5 years.PerspectivesTele-HC will be the first randomized study to evaluate the effectiveness of an integrated remote TM and patient-centric HC strategy for adult patients recently hospitalized with ADHF compared to standard care. Results will inform regarding the potential to pursue larger clinical outcome trials utilizing remote TM in combination with HC for the HF patient population.[email protected] NHLBI R01 AG 41676 BackgroundChronic heart failure (HF) is characterized by frequent hospitalization, suboptimal self-care and high readmission rates. Remote telemonitoring (TM) combined with health coaching (HC) has the potential to favorably impact drivers of HF readmission including communication, care coordination, self-care, social support and lifestyle choices. Chronic heart failure (HF) is characterized by frequent hospitalization, suboptimal self-care and high readmission rates. Remote telemonitoring (TM) combined with health coaching (HC) has the potential to favorably impact drivers of HF readmission including communication, care coordination, self-care, social support and lifestyle choices. HypothesisRemote TM combined with HC will decrease readmission rates for patients with acute decompensated heart failure (ADHF). Remote TM combined with HC will decrease readmission rates for patients with acute decompensated heart failure (ADHF). MethodsThe Tele-HC multicenter trial will randomize 304 subjects with ADHF prior to hospital dismissal to either standard management including HC versus management facilitated by combined remote TM and HC. Subjects with either HF with reduced ejection fraction or HF with preserved ejection fraction will be enrolled. Subjects will have been stabilized during hospitalization for ADHF at time of discharge. The BodyGuardian® remote TM platform (FDA 510k approved for non-lethal arrhythmia monitoring) will be deployed for those subjects randomized to TM. The BodyGuardian® platform is comprised of a front-end, external, removable, wireless sensor-patch linked to cell-phone technology for transmission of remotely acquired physiologic signals to the Cloud with download to a back-end 24/7 monitoring center which supports automated EKG rhythm classification, as well as heart rate, blood pressure, weight, activity and respiration monitoring including data summary, analysis and communication to the electronic health record and providers. The remote TM platform also enables individualized programming of alert thresholds to facilitate communication between providers and patients. Subjects randomized to TM will wear the remote TM sensor-patch continuously for 60 days. These subjects will also receive the HC service provided by the C3 Nexus High Touch system, which will be integrated with the remote TM platform. The primary endpoint of the Tele-HC trial will be the readmission frequency at 60 days subsequent to hospital dismissal for ADHF. The primary analysis will be a Cochran-Mantel-Haenszel Chi-square test to compare the 60-day readmission rates between the two interventions while controlling for enrolling hospital site. The overall study duration will be two years with subject enrollment over an interval of 1.5 years. The Tele-HC multicenter trial will randomize 304 subjects with ADHF prior to hospital dismissal to either standard management including HC versus management facilitated by combined remote TM and HC. Subjects with either HF with reduced ejection fraction or HF with preserved ejection fraction will be enrolled. Subjects will have been stabilized during hospitalization for ADHF at time of discharge. The BodyGuardian® remote TM platform (FDA 510k approved for non-lethal arrhythmia monitoring) will be deployed for those subjects randomized to TM. The BodyGuardian® platform is comprised of a front-end, external, removable, wireless sensor-patch linked to cell-phone technology for transmission of remotely acquired physiologic signals to the Cloud with download to a back-end 24/7 monitoring center which supports automated EKG rhythm classification, as well as heart rate, blood pressure, weight, activity and respiration monitoring including data summary, analysis and communication to the electronic health record and providers. The remote TM platform also enables individualized programming of alert thresholds to facilitate communication between providers and patients. Subjects randomized to TM will wear the remote TM sensor-patch continuously for 60 days. These subjects will also receive the HC service provided by the C3 Nexus High Touch system, which will be integrated with the remote TM platform. The primary endpoint of the Tele-HC trial will be the readmission frequency at 60 days subsequent to hospital dismissal for ADHF. The primary analysis will be a Cochran-Mantel-Haenszel Chi-square test to compare the 60-day readmission rates between the two interventions while controlling for enrolling hospital site. The overall study duration will be two years with subject enrollment over an interval of 1.5 years. PerspectivesTele-HC will be the first randomized study to evaluate the effectiveness of an integrated remote TM and patient-centric HC strategy for adult patients recently hospitalized with ADHF compared to standard care. Results will inform regarding the potential to pursue larger clinical outcome trials utilizing remote TM in combination with HC for the HF patient population.[email protected] NHLBI R01 AG 41676 Tele-HC will be the first randomized study to evaluate the effectiveness of an integrated remote TM and patient-centric HC strategy for adult patients recently hospitalized with ADHF compared to standard care. Results will inform regarding the potential to pursue larger clinical outcome trials utilizing remote TM in combination with HC for the HF patient population. [email protected] NHLBI R01 AG 41676