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

NCT06364748 | Completed FDA Device

• 1 other identifier: 002-2024-Shalowitz
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Improvement of early identification of bevacizumab-induced hypertension with usual care blood pressure monitoring

  Through study completion, an average of 18 months

• Improvement of early identification of bevacizumab-induced hypertension with remote blood pressure monitoring

  Through study completion, an average of 18 months

• Patient satisfaction with usual care blood pressure monitoring

  1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment

• Patient satisfaction with remote blood pressure monitoring

  1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment

Study Arms (2)

Smart Cuff Group

ACTIVE COMPARATOR

Smart blood pressure cuff

Device: Cellular enabled blood pressure cuff

Control Group

PLACEBO COMPARATOR

Standard of care

Device: Standard of Care Cuff

Interventions

Cellular enabled blood pressure cuff DEVICE

Smart cuff

Smart Cuff Group

Standard of Care Cuff DEVICE

Standard blood pressure cuff

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is a male or female 18 years of age or older.
• Participant is a current patient at West Michigan Cancer Center/Bronson Cancer Center.
• Participant is receiving bevacizumab as part of active treatment.
• Participant is willing and able to provide written informed consent.

You may not qualify if:

• Participant is unable to understand English.
• Participant is hospitalized.
• Participants are unable to obtain blood pressure readings at home.

Sponsors & Collaborators

• West Michigan Cancer Center: lead
• Veta Health: collaborator

Study Sites (1)

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Shalowitz

  West Michigan Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 15, 2024
• Study Start: March 11, 2024
• Primary Completion: March 26, 2025
• Study Completion: September 26, 2025
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)