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OpenTrials
Completed

NCT Number: NCT06364748

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Cellular enabled blood pressure cuff

Device

Smart cuff

Standard of Care Cuff

Device

Standard blood pressure cuff

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

    Time frame: 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 outcomes

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

    Time frame: Through study completion, an average of 18 months

    Frequency of clinician notifications of clinically significant elevations in systolic and/or diastolic blood pressure readings

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

    Time frame: Through study completion, an average of 18 months

    Frequency of clinician notifications of clinically significant elevations in systolic and/or diastolic blood pressure readings

  3. Patient satisfaction with usual care blood pressure monitoring

    Time frame: 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"

  4. Patient satisfaction with remote blood pressure monitoring

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

West Michigan Cancer Center

Other

Collaborators

  • Veta Health

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2024
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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