Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Cellular enabled blood pressure cuff; Device: Standard of Care Cuff

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Standard of care	Device: Standard of Care Cuff; Standard blood pressure cuff
Active Comparator: Smart Cuff Group; Smart blood pressure cuff	Device: Cellular enabled blood pressure cuff; Smart cuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: West Michigan Cancer Center
• Collaborators: Veta Health
• Investigators: Principal Investigator: David Shalowitz, West Michigan Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): September 26, 2025

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: October 6, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 002-2024-Shalowitz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes