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Trial Title:
Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer
NCT ID:
NCT06364748
Condition:
Hypertension
Conditions: Official terms:
Hypertension
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Cellular enabled blood pressure cuff
Description:
Smart cuff
Arm group label:
Smart Cuff Group
Intervention type:
Device
Intervention name:
Standard of Care Cuff
Description:
Standard blood pressure cuff
Arm group label:
Control Group
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
West Michigan Cancer Center
Address:
City:
Kalamazoo
Zip:
49007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wendi Mitchell
Phone:
269-373-7443
Email:
wmitchell@wmcc.org
Contact backup:
Last name:
Kathleen Allen
Phone:
269-373-7452
Email:
kallen@wmcc.org
Start date:
March 11, 2024
Completion date:
September 2025
Lead sponsor:
Agency:
West Michigan Cancer Center
Agency class:
Other
Collaborator:
Agency:
Veta Health
Agency class:
Other
Source:
West Michigan Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06364748
