免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Hypertension Management in Cancer Patients

Hypertension Management in Cancer Patients

Study Description
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 Show detailed description
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
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
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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

Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Duke Institute for Health Innovation
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date January 11, 2021
Actual Study Start Date  ICMJE December 10, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Clinic-based Blood Pressure [ Time Frame: 12 weeks ]
    To capture all clinic-based blood pressure levels for each patient during the study.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypertension Management in Cancer Patients
Official Title  ICMJE Hypertension Management in Cancer Patients: Bringing PCPs "Back" Into Cancer Care
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Blood Pressure
  • Hypertension
  • Cancer
  • Cancer, Breast
  • Cancer of Prostate
  • CLL
  • Hematopoietic Malignancy
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Other: Automated Messaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919214
Other Study ID Numbers  ICMJE Pro00102260
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Duke Institute for Health Innovation
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院