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Blood PressureNCT03919214

Hypertension Management in Cancer Patients

A study testing Automated Messaging in people with Blood Pressure and Hypertension, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The investigators propose to leverage new technology using the Qardio app for iPhone and Android devices to automatically upload blood pressures, using a well-validated blue tooth blood pressure monitor (QardioArm), directly into the Duke electronic health record system (EPIC). Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Blood Pressure, Hypertension, Cancer
What is being tested?
Automated Messaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
10 Dec 2019to 3 Jun 2020
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 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A total of 40 patients with a diagnosis of hypertension who are 18-74 years old who fall under the following criteria will be screened:
  • 10 women with Stage I-III breast cancer who are on active cancer therapy and are receiving either an anthracycline (doxorubicin) or antiHER2 (trastuzumab or pertuzumab)
  • 10 men with prostate cancer on androgen deprivation therapy (ADT)
  • 10 individuals with CLL on ibrutinib therapy
  • 10 HSCT survivors (who had a malignancy)
  • Have a smartphone (iPhone or Android)
Show all 9Show fewer
  • Have a Duke primary care provider and Duke oncologist (who is being treated at the Duke Cancer Center)
  • Have access or willing to set up access to Duke MyChart.
  • English speaking patients

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Hypertension Management in Cancer Patients: Bringing PCPs "Back" Into Cancer Care

The investigators propose to leverage new technology using the Qardio app for iPhone and Android devices to automatically upload blood pressures, using a well-validated blue tooth blood pressure monitor (QardioArm), directly into the Duke electronic health record system (EPIC). Further, the investigators propose to develop an automated EHR (electronic health record) messaging system utilizing the home blood pressures that will be sent to the participant's PCP, with copies to the participant and the primary oncologist. This is a 12-week prospective non-randomized implementation study. 40 patients who are 18-74 years old who fall under the following criteria will be screened: 10 women with Stage 1-III breast cancer who are receiving either an anthracycleine of antiHER2 therapy, 10 men with prostate cancer on ADT, 10 individuals with CLL on ibrutinib therapy, and 10 individuals who are hematopoietic stem cell transplantation (HSCT) survivors. In Phase 1 (Weeks 1-4) of the study, participants will self-monitor their blood pressure using the QardioArm wireless upper arm blood pressure monitor 3 times per week. In Phase 2 (Weeks 5-12), the investigators will implement the auto-messaging system triggered by an abnormal weekly average systolic or diastolic blood pressure. The investigators will adapt the conceptual framework of Muldoon and colleagues whereby home blood pressure monitoring is combined with office blood pressures to optimize data for the primary care provider's clinical decision making. {Participants will be asked to complete a paper survey, upon enrollment, that will include life chaos and medication adherence questions. There will also be an end-of-study feedback survey (usability and acceptability questions through REDCap) for both the participants and their primary care providers. This is an implementation study with a descriptive analysis. The data generated from the study will be used in future studies, including testing of different interventions aimed at optimizing blood pressure control among patients on active cancer therapy. This study presents no greater than minimal risk to the subjects and adverse events are not anticipated.

Read the detailed description

This is a 12-week prospective study with two phases. In Phase 1 (Weeks 1-4), participants will self-monitor their blood pressure using the Qardio bluetooth device. In Phase 2 (Weeks 5-12), the investigators will implement the auto-messaging system triggered by a weekly average systolic blood pressure >140 mm Hg or diastolic pressure >90 mm Hg. As per the recommendation of the ACC/AHA, the target blood pressure for patients with Stage A (at risk for heart failure) is systolic <130 / diastolic <80. This guideline is also consistent with the ACC/AHA blood pressure guideline for patients at risk for myocardial infarction. For this pilot study, our target blood pressure in messaging to Duke primary care providers will be <140 mm Hg and <90 mm Hg. For this study, the investigators will adapt the conceptual framework of Muldoon and colleagues whereby home blood pressure monitoring is combined with office blood pressures to optimize data for the PCP's clinical decision-making.

The investigators will use the QardioArm wireless upper arm blood pressure monitor. The investigators opted to use this device because it is validated, and has been approved to be integrated into the Duke EHR system. This QardioArm monitor is compatible with both iPhone and Android devices, which will provide an efficient method of transferring Bluetooth data to Epic. Within Epic, the home blood pressures will be uploaded directly from a smartphone to REVIEW FLOWSHEETS, MYCHART HEALTKIT TRACKER.

Participants will use the QardioArm device to obtain 3 separate blood pressure measurements per week (2 morning, 1 evening). The 2 morning blood pressure measurements will be taken between 5-11am before any caffeine intake or exercise. The evening blood pressure measurement will be taken between 4-12pm. During Phase 1, the investigators will review the individual and weekly average blood pressures and identify values that appear to be in error. This review will be used to refine the system and further train the participants on home blood pressure measurements if needed. Also during this phase, the investigators will develop the Blood Pressure Management Clinical Pathway for Patients and Survivors, based upon the ACC/AHA blood pressure guidelines and the ACC/AHA guidelines for prevention of cardiotoxicity. Lastly, in this phase, the investigators will develop the primary care provider messages to be implemented in Phase 2. These short messages will alert the Duke primary care provider that an abnormal weekly average blood pressure triggered the message and provide the target blood pressure for the patient. The primary care provider will be asked to either evaluate the patient in clinic or manage by telephone. A copy of the message will also be routed to the patient and to the primary oncologist. The investigators will also include a link within the message to an internal Maestro site for further details regarding the blood pressure target levels, a brief description of the chemotherapy the patient is on, and preferred antihypertensive medications in this population. Consistent with the ACC/AHA guidelines for hypertension management, including patients receiving cardiotoxic therapy, the investigators will use the following classification system for the weekly average systolic and diastolic blood pressures. Normal: systolic 95-120 mm Hg, diastolic <80; Elevated: systolic 120-129, diastolic < 80; Stage 1 Hypertension: systolic 130-139, diastolic 80-89; Stage 2 Hypertension: > 140, diastolic > 90. In Phase 2, the investigators will implement and test the clinical pathways and messaging system.

A total of 40 patients with a diagnosis of hypertension who are 18-74 years old who fall under the following criteria will be screened:

  • 10 women with Stage 1-III breast cancer who are on active cancer therapy and are receiving either an anthracycline (doxorubicin) or antiHER2 (trastuzumab or pertuzumab)
  • 10 men with prostate cancer on androgen deprivation therapy (ADT)
  • 10 individuals with CLL on ibrutinib therapy
  • 10 HSCT survivors (who had a malignancy)
  • Have a smartphone (iPhone or Android)
  • Have a Duke primary care provider and Duke oncologist (who is being treated at the Duke Cancer Center)
  • Have access or willing to set up access to Duke MyChart (patient portal).
  • English speaking patients

The investigators selected these four groups for the following reasons. Stage I-III breast cancer has a 5-year cure rate exceeding 90%. Anthracyclines (doxorubicin) and antiHER2 therapy (trastuzumab or pertuzumab), mainstays of breast cancer therapy, are cardiotoxic and associated with acute and long-term heart failure. Pre-existing hypertension is a key risk factor for development of heart failure in this group. Androgen deprivation therapy is associated with an increased risk of CVD, again, hypertension is a key risk factor for development of CVD in this group. Monotherapy with ibrutinib, or similar novel tyrosine kinase inhibitors, has substantially extended life expectancy for individuals with symptomatic or advanced CLL. Notably, ibrutinib may lead to new onset or progressive hypertension and/or atrial fibrillation. HSCT survivors are exposed to cardiotoxic therapies (anthracyclines, chest radiotherapy) pre-HSCT. Post HSCT complications (GvHD) and chronic comorbidities (hypertension) also contribute to the group's increased risk for developing CVD and congestive heart failure. Thus, blood pressure management is an essential component to improving long-term outcomes for patients in these four groups.

To develop and implement the messaging system, it is important to have the patient, the oncologist, and the primary care provider all in the Duke EHR and patient portal.

Being tested
Automated Messaging
Medical subject headings
Hypertension, Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automated MessagingOther

    Also called QardioArm Blood Pressure Measurements and Automated Messaging

    This is a 12-week prospective study with two phases. Participants will use the QardioArm device to obtain 3 separate blood pressure measurements per week (2 morning, 1 evening). The QardioArm device will only be used as a tool to gather data. In Phase 1 (Weeks 1-4), participants will self-monitor their blood pressure using the Qardio Bluetooth device. In Phase 2 (Weeks 5-12), we will implement the auto-messaging system triggered by a weekly average systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg.

Study groups in NCT03919214
Study groupRoleWhat they receive
QardioArm and Messaging SystemOtherParticipants will self-monitor their blood pressure using the Qardio Bluetooth device and obtain 3 separate blood pressure measurements per week (2 morning, 1 evening) for 12 weeks. An automated messaging system for blood pressure management will be triggered by a weekly average systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg. This automated message will be sent to the participant's primary care provider, with copies to the participant and the primary medical oncologist.
Receives: Other: Automated Messaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Adherence

    To determine the proportions of patients who completed the 3 blood pressure measurements per week (goal of 80% adherence).

    Measured: 12 weeks

  2. Patient Blood Pressure

    To determine the proportions of patients, by disease group, who have a blood pressure that is above (or below) the target levels.

    Measured: 12 weeks

  3. Primary Care Provider Activation

    To determine the proportions of primary care providers who (a) received and (b) acted upon the automated message.

    Measured: 12 weeks

  4. End of Study Patient Blood Pressure - Within Target Levels

    To determine the proportions of patients who are within target levels with the final weekly average pressures.

    Measured: 1 week (end of study)

  5. End of Study Patient Blood Pressure - Outside of Target Levels

    To determine the proportions of patients who are outside of target levels with the final weekly average pressures.

    Measured: 1 week (end of study)

Secondary outcomes (3)
  1. Clinic-based Blood Pressure

    To capture all clinic-based blood pressure levels for each patient during the study.

    Measured: 12 weeks

  2. Usability of QardioArm device

    At the end of the study, a brief REDCap feedback survey of patients to better understand the usability of the QardioArm device will be given.

    Measured: 1 week (end of study)

  3. Acceptability of the Messaging System

    At the end of the study, a brief REDCap feedback survey of patients and their primary care providers and oncologists to better understand the acceptability of the messaging system and the pathways will be given.

    Measured: 1 week (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start10 Dec 2019
  3. Primary completion3 Jun 2020
  4. Study completion3 Jun 2020

Why it stopped: Initially suspended due to Covid-19. After much consideration, it was determined that we do not have the bandwidth to resume recruitment or any activities for this project.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03919214
Sponsor's protocol ID
Pro00102260
Status last verified
Apr 2023
First submitted
15 Apr 2019
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Automated Messaging in people with Blood Pressure and Hypertension, run by Duke University 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 9 inclusion and 0 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 19 Apr 2023. 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. 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: Initially suspended due to Covid-19. After much consideration, it was determined that we do not have the bandwidth to resume recruitment or any activities for this project.). 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?

Patient Adherence (time frame: 12 weeks). The study lists 5 primary outcomes in all. 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 19 Apr 2023.

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