An interventional study of Peripherals with HealthInterlink technology in Heart Failure, sponsored by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH. Status unknown at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2016-03-31.
Sponsored by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH · Not applicable, Interventional, and Prevention
The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).
The objective of this remote monitoring study is to evaluate return on investment and end-user clinical outcomes associated with the use of self-monitoring peripherals and tablet/smartphone-based Welch Allyn HealthInterlink technology without intervention (Control), HealthInterlink remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1), and HealthInterlink remote monitoring with nurse research assistant follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2 added to Intervention 1).
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 163 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Control: Peripherals with HealthInterlink technology will record and transmit data, without intervention. Subject is able to view graphed data, bring the HealthInterlink tablet/smartphone to the physician's office and share data with family/other caregiver.
Device: Peripherals with HealthInterlink technology
Intervention 1: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver.
Device: Peripherals with HealthInterlink technology
Intervention 2: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver, and a call will be placed by the nurse research assistant to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts). The physicians will have access to the subject's data on a web-based program.
Device: Peripherals with HealthInterlink technology
home remote monitoring
Also known as: Welch Allyn, Blood Pressure monitor, Weight Scale, Pulse Oximeter, tablet/smartphone-based technology
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
31 days post discharge with a heart failure-related hospital re-hospitalization.
Time frame: 31 days
Communication with healthcare provider or emergency department
Communication that resulted in unplanned healthcare provider office visits or visit to emergency department
Time frame: 31 days
Number of non-conformity issues
Number of non-conformity telephone reminder texts, emails, and/or calls.
Time frame: 31 days
Health-related quality of life Questionnaire
Health-related quality of life
Time frame: 31 days
Subject satisfaction Questionnaire
Subject satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use, time to complete testing and questionnaire, benefit that promoted better health
Time frame: 31 days
Physician satisfaction Questionnaire
Physician satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use of software, benefit that promoted better communication with subject.
Time frame: 31 days
Cost of system and intervention per subjects
Economic viability of remote monitoring program based on daily cost of system and intervention per subjects in comparison with control and treatment groups.
Time frame: 31 days
Number and type of incidents
Number and type of incident based on predefined criteria from the remote monitoring data (clinical signs and symptoms related to worsening of cardiac insufficiency or to its complications).
Time frame: 31 days
Subject attrition
Rate of subjects discontinuing the study due to Patient Request, Patient Complaint, Patient Transferred to higher level of care (ACLF, SNF), Patient Hospitalized, Physician Request Monitoring No Longer Needed (Resolution of Disease Process, Change in Treatment), Physician Complaint, Patient Expired, Patient all-cause mortality or Without other identifiable cause.
Time frame: 31 days
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH