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| Name | Class |
|---|---|
| Veta Health | UNKNOWN |
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A randomized trial of remote blood pressure monitoring, compared to usual care, in patients receiving bevacizumab to determine whether remote blood pressure monitoring improves the collection of blood pressure data, identification and management of clinically significant hypertension, and patient satisfaction.
Remote patient monitoring (RPM) technology has the potential to improve the early detection and management of clinically significant hypertension in cancer patients undergoing therapy with bevacizumab, by allowing immediate communication of abnormal measurements to the clinical care team. Additionally, RPM may decrease patients' and caregivers' burdens of ongoing cancer care through an improved user experience compared to usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart Cuff Group | Active Comparator | Smart blood pressure cuff |
|
| Control Group | Placebo Comparator | Standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellular enabled blood pressure cuff | Device | Smart cuff |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether remote blood pressure monitoring improves adherence to recommendations for daily systolic and diastolic blood pressure monitoring compared to usual care | Comparing the number of participants who complete the recommended daily blood pressure readings available for clinician assessment via review of a remote blood pressure monitoring platform versus a patient recorded blood pressure log book | Through study completion, an average of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of early identification of bevacizumab-induced hypertension with usual care blood pressure monitoring | Frequency of clinician notifications of clinically significant elevations in systolic and/or diastolic blood pressure readings | Through study completion, an average of 18 months |
| Improvement of early identification of bevacizumab-induced hypertension with remote blood pressure monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Shalowitz | West Michigan Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Standard of Care Cuff |
| Device |
Standard blood pressure cuff |
|
Frequency of clinician notifications of clinically significant elevations in systolic and/or diastolic blood pressure readings |
| Through study completion, an average of 18 months |
| Patient satisfaction with usual care blood pressure monitoring | Patient questionnaire containing seven questions, using a 5-point Likert scale, where 1 equals "Strongly Disagree" and 5 equals "Strongly Agree" for six questions. One question is measured using a 5-point Likert scale, where 1 equals "Very Difficult" and five equals "Not Difficult At All" | 1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment |
| Patient satisfaction with remote blood pressure monitoring | Patient questionnaire sent via mobile application by Veta Health, containing seven questions, using a 5-point Likert scale, where 1 equals "Strongly Disagree" and 5 equals "Strongly Agree" for six questions. One question is measured using a 5-point Likert scale, where 1 equals "Very Difficult" and five equals "Not Difficult At All" | 1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment |