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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06364748
• Other study ID #: 002-2024-Shalowitz
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: West Michigan Cancer Center
• Contact: Wendi Mitchell
• Phone: 269-373-7443
• Email: research[@]wmcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Cellular enabled blood pressure cuff
Smart cuff
• Standard of Care Cuff
Standard blood pressure cuff

Locations

Country	Name	City	State
United States	West Michigan Cancer Center	Kalamazoo	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
West Michigan Cancer Center	Veta Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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