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Hypertension Management in Cancer Patients

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ClinicalTrials.gov Identifier: NCT03919214
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Duke Institute for Health Innovation
Information provided by (Responsible Party):
Duke University

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Blood Pressure Hypertension Cancer Cancer, Breast Cancer of Prostate CLL Hematopoietic Malignancy Other: Automated Messaging Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Hypertension Management in Cancer Patients: Bringing PCPs "Back" Into Cancer Care
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020


Arm Intervention/treatment
QardioArm and Messaging System
Participants 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.
Other: 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.
Other Name: QardioArm Blood Pressure Measurements and Automated Messaging




Primary Outcome Measures :
  1. Patient Adherence [ Time Frame: 12 weeks ]
    To determine the proportions of patients who completed the 3 blood pressure measurements per week (goal of 80% adherence).

  2. Patient Blood Pressure [ Time Frame: 12 weeks ]
    To determine the proportions of patients, by disease group, who have a blood pressure that is above (or below) the target levels.

  3. Primary Care Provider Activation [ Time Frame: 12 weeks ]
    To determine the proportions of primary care providers who (a) received and (b) acted upon the automated message.

  4. End of Study Patient Blood Pressure - Within Target Levels [ Time Frame: 1 week (end of study) ]
    To determine the proportions of patients who are within target levels with the final weekly average pressures.

  5. End of Study Patient Blood Pressure - Outside of Target Levels [ Time Frame: 1 week (end of study) ]
    To determine the proportions of patients who are outside of target levels with the final weekly average pressures.


Secondary Outcome Measures :
  1. Clinic-based Blood Pressure [ Time Frame: 12 weeks ]
    To capture all clinic-based blood pressure levels for each patient during the study.

  2. Usability of QardioArm device [ Time Frame: 1 week (end of study) ]
    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.

  3. Acceptability of the Messaging System [ Time Frame: 1 week (end of study) ]
    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.



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919214


Contacts
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Contact: Kevin C Oeffinger, MD 919-668-2122 kevin.oeffinger@duke.edu
Contact: Leah Zullig, PhD 919-668-0300 leah.zullig@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Duke Institute for Health Innovation

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03919214     History of Changes
Other Study ID Numbers: Pro00102260
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Hypertension
Vascular Diseases
Cardiovascular Diseases
Breast Diseases
Skin Diseases
Genital Diseases, Male
Hematologic Diseases