HypertensionNCT06364748
Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer
A study testing Cellular enabled blood pressure cuff in people with Hypertension, run by West Michigan Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Cellular enabled blood pressure cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 7 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participant is unable to understand English.
- Participant is hospitalized.
- Participants are unable to obtain blood pressure readings at home.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Cellular enabled blood pressure cuff, Standard of Care Cuff
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellular enabled blood pressure cuffDevice
Cellular enabled blood pressure cuff vs. standard blood pressure cuff
Standard of Care CuffDevice
Cellular enabled blood pressure cuff vs. standard blood pressure cuff
| Study group | Role | What they receive |
|---|---|---|
| Smart Cuff Group | Active comparator | Smart blood pressure cuff Receives: Device: Cellular enabled blood pressure cuff |
| Control Group | Placebo comparator | Standard of care Receives: Device: Standard of Care Cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Frequency of clinician notifications of clinically significant elevations in systolic and/or diastolic blood pressure readings
Measured: Through study completion, an average of 18 months
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
Measured: Through study completion, an average of 18 months
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"
Measured: 1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment
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"
Measured: 1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start11 Mar 2024
- Primary completion26 Mar 2025
- Study completion7 Oct 2025
Why it stopped: Dr. Shalowitz resigned from the West Michigan Cancer Center. Target enrollment was 60 and only 18 were analyzed. No conclusions can be drawn from this interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Michigan Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Shalowitz, Principal investigator, West Michigan Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364748
- Sponsor's protocol ID
- 002-2024-Shalowitz
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer
- ClinicalTrials.gov ID
- NCT06364748
- Acronym / sponsor ID
- 002-2024-Shalowitz
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dr. Shalowitz resigned from the West Michigan Cancer Center. Target enrollment was 60 and only 18 were analyzed. No conclusions can be drawn from this interim analysis.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- West Michigan Cancer CenterUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Cuff Group | Active comparator | Device: Cellular enabled blood pressure cuffSmart blood pressure cuff |
| Control Group | Placebo comparator | Device: Standard of Care CuffStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Participant is unable to understand English.
- Participant is hospitalized.
- Participants are unable to obtain blood pressure readings at home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cellular enabled blood pressure cuffCellular enabled blood pressure cuff vs. standard blood pressure cuff | Device | Smart Cuff Group |
| Standard of Care CuffCellular enabled blood pressure cuff vs. standard blood pressure cuff | Device | Control Group |
Primary outcome
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
4 secondary outcomes
Improvement of early identification of bevacizumab-induced hypertension with usual care blood pressure monitoring
Time frame: Through study completion, an average of 18 months
Improvement of early identification of bevacizumab-induced hypertension with remote blood pressure monitoring
Time frame: Through study completion, an average of 18 months
Patient satisfaction with usual care blood pressure monitoring
Time frame: 1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment
Patient satisfaction with remote blood pressure monitoring
Time frame: 1 week after enrollment, 6 weeks after enrollment and 12 weeks after enrollment
Results and safety
The study was stopped early (reason given: Dr. Shalowitz resigned from the West Michigan Cancer Center. Target enrollment was 60 and only 18 were analyzed. No conclusions can be drawn from this interim analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Shalowitz principal investigator
West Michigan Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellular enabled blood pressure cuff in people with Hypertension, run by West Michigan Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Dr. Shalowitz resigned from the West Michigan Cancer Center. Target enrollment was 60 and only 18 were analyzed. No conclusions can be drawn from this interim analysis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.