Hypertension
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICECellular enabled blood pressure cuff
Cellular enabled blood pressure cuff vs. standard blood pressure cuff
DEVICEStandard of Care Cuff
Cellular enabled blood pressure cuff vs. standard blood pressure cuff
Sponsors
West Michigan Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant is a male or female 18 years of age or older. 2. Participant is a current patient at West Michigan Cancer Center/Bronson Cancer Center. 3. Participant is receiving bevacizumab as part of active treatment. 4. Participant is willing and able to provide written informed consent.
Exclusion criteria
1. Participant is unable to understand English. 2. Participant is hospitalized. 3. Participants are unable to obtain blood pressure readings at home.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine whether remote blood pressure monitoring improves adherence to recommendations for daily systolic and diastolic blood pressure monitoring compared to usual care | Through study completion, an average of 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of early identification of bevacizumab-induced hypertension with usual care blood pressure monitoring | Through study completion, an average of 18 months | Frequency of clinician notifications of clinically significant elevations in systolic and/or diastolic blood pressure readings |
| Improvement of early identification of bevacizumab-induced hypertension with remote blood pressure monitoring | Through study completion, an average of 18 months | Frequency of clinician notifications of clinically significant elevations in systolic and/or diastolic blood pressure readings |
| Patient satisfaction with usual care blood pressure monitoring | 1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment | 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" |
| Patient satisfaction with remote blood pressure monitoring | 1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment | 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" |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Shalowitz
West Michigan Cancer Center
Outcome results
None listed