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| Name | Class |
|---|---|
| Welch Allyn | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | 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. |
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| Intervention 1 | Experimental | 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. |
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| Intervention 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripherals with HealthInterlink technology | Device | home remote monitoring |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 31 days |
| Measure | Description | Time Frame |
|---|---|---|
| Communication with healthcare provider or emergency department | Communication that resulted in unplanned healthcare provider office visits or visit to emergency department | 31 days |
| Number of non-conformity issues |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 31 days |
| Subject attrition |
Inclusion Criteria:
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theresa Morrison, PhD | Contact | 239-624-4384 | theresa.morrison@nchmd.org | |
| Laurie Zone-Smith, PhD | Contact | 239-624-4986 | laurie.zonesmith@nchmd.org |
| Name | Affiliation | Role |
|---|---|---|
| Theresa Morrison, PhD | NCH Healthcare System Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCH Healthcare System | Recruiting | Naples | Florida | 34102 | United States |
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| Label | URL |
|---|---|
| Healthcare system web site | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015924 | Blood Pressure Monitors |
| ID | Term |
|---|---|
| D019722 | Sphygmomanometers |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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Number of non-conformity telephone reminder texts, emails, and/or calls.
| 31 days |
| Health-related quality of life Questionnaire | Health-related quality of life | 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 | 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. | 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. | 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.
| 31 days |