Heart Failure
Conditions
Keywords
telemedicine, heart failure, home blood pressure monitoring
Brief summary
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).
Detailed description
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).
Interventions
DEVICEPeripherals with HealthInterlink technology
home remote monitoring
Sponsors
Welch Allyn
NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Absence of significant vision, hearing, or other communication deficits * English speaking; * Capable and willing to give informed consent; * Participated in the in-patient heart failure class within the last three months. Acceptable candidate for elective, non-emergent, remote monitoring as determined by ordering physician; * Living in a private home; * Hospital admission for Heart Failure or decompensation in the previous 12 months * New York Heart Association (NYHA) classes II-IV, as assigned by the nurse researcher, trained by a cardiologist * Cardiac aetiology: ischaemic, idiopathic, hypertensive, or valvular * Left ventricular ejection fraction \<40% s an index of systolic dysfunction, combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure. or * NYHA class II-III who had an ejection fraction \>40% and evidence of diastolic left ventricular dysfunction. * Optional subject with a diagnosis of diabetes (indicated by HbA1c \>7).
Exclusion criteria
* Currently involved in other investigational clinical trials (unless permission is granted by other study PI); * Females who are pregnant, planning to become pregnant within 3 months, or lactating; * Requirement for emergent placement other than private home (subject's condition would be compromised if there is a delay in placement). * Myocardial infarction, revascularization or Implantable Cardioverter Defibrillator (ICD) implantation in the previous 6 months angina or objective myocardial ischaemia requiring future revascularization implanted ventricular or atrial pacemaker (except dual chamber ICD pacemakers with good sinus activity); * End-stage heart failure requiring regular inotropic drug infusions; * Chronic renal failure requiring dialysis treatment and * Unstable angina.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization) | 31 days | 31 days post discharge with a heart failure-related hospital re-hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Communication with healthcare provider or emergency department | 31 days | Communication that resulted in unplanned healthcare provider office visits or visit to emergency department |
| Number of non-conformity issues | 31 days | Number of non-conformity telephone reminder texts, emails, and/or calls. |
| Health-related quality of life Questionnaire | 31 days | Health-related quality of life |
| Physician satisfaction Questionnaire | 31 days | 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. |
| Cost of system and intervention per subjects | 31 days | Economic viability of remote monitoring program based on daily cost of system and intervention per subjects in comparison with control and treatment groups. |
| Subject satisfaction Questionnaire | 31 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number and type of incidents | 31 days | 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). |
| Subject attrition | 31 days | 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. |
Countries
United States
Contacts
Primary ContactTheresa Morrison, PhD
Backup ContactLaurie Zone-Smith, PhD
Outcome results
None listed