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

West Michigan Cancer Center

Status: Completed

Conditions: Hypertension

Treatments: Device: Standard of Care Cuff; Device: Cellular enabled blood pressure cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT06364748

002-2024-Shalowitz

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

Smart Cuff Group

Active Comparator group

Description:

Smart blood pressure cuff

Treatment:

Device: Cellular enabled blood pressure cuff

Control Group

Placebo Comparator group

Description:

Standard of care

Treatment:

Device: Standard of Care Cuff