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Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (Hyperlink)

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ClinicalTrials.gov Identifier: NCT00781365
Recruitment Status : Completed
First Posted : October 29, 2008
Results First Posted : July 14, 2014
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
HealthPartners Institute

Tracking Information
First Submitted Date  ICMJE October 28, 2008
First Posted Date  ICMJE October 29, 2008
Results First Submitted Date  ICMJE February 27, 2014
Results First Posted Date  ICMJE July 14, 2014
Last Update Posted Date April 13, 2017
Study Start Date  ICMJE March 2009
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
  • Blood Pressure Control [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)
  • Mean Systolic Blood Pressure [ Time Frame: Baseline, 6 months, 12 months, 18 months, 54 months ]
    Systolic blood pressure at baseline and 4 time points
  • Mean Diastolic Blood Pressure [ Time Frame: Baseline, 6 months, 12 months, 18 months, 54 months ]
    Mean diastolic blood pressure at baseline and 4 time points
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2008)
To test a robust, multi-modal intervention to achieve and maintain high levels of BP control (<140/90 mmHg, or <130/80 mmHg if diabetes or kidney disease is present) in primary care patients with uncontrolled blood pressure [ Time Frame: 18 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2008)
To compare satisfaction with care and cost of care in the treatment intervention and usual care groups. [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home Blood Pressure Telemonitoring and Case Management to Control Hypertension
Official Title  ICMJE Home Blood Pressure Telemonitoring and Case Management to Control Hypertension
Brief Summary In this project we develop and implement an intervention to improve hypertension control in a primary care setting that takes advantage of new technology (home blood pressure telemonitoring) and team models of care (pharmacist case management). The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.
Detailed Description Blood pressure (BP) is controlled to recommended levels in only 1 in 3 people with hypertension, and there has been little improvement since the late 1980s, despite advances in evidence to support aggressive hypertension control, and availability of many new and effective antihypertensive drugs. It is clear that meaningful and sustained improvement in hypertension control will likely require fundamental changes in the current physician-centered office-visit based model of caring for hypertension. In this project we develop and implement an intervention that takes advantage of new technology and team models of care to improve BP measurement and control, solving the problems that have limited the application of case management approaches to hypertension care improvement. The study will take place in a diverse population of adults with hypertension cared for in a real-world primary care setting. The Telemonitoring Intervention (TI) integrates 2 innovative components: First, home BP measures are done using state-of-the-art modem-enabled automated equipment that internally stores and electronically transmits BP data through a simple touch-tone telephone connection to a secure web site. Second, a pharmacist case manager integrated with the primary care team through a jointly used electronic medical record (EMR) and formulary adjusts antihypertensive therapy using an approved written protocol, under a collaborative practice agreement with physicians. Treatment decisions are based on home BP data and are discussed and communicated to patients in telephone visits with the pharmacist case manager. Two-way communication between the pharmacist case manager and the patient's primary care team is assured by using a shared EMR and by additional secure messaging of the results of every pharmacist encounter to the primary care team. To assess the impact of the TI on hypertension control, patient satisfaction, and costs of care, we will conduct a cluster-randomized trial, assigning 16 primary care clinics and 450 of their nested patients with uncontrolled hypertension to either a Usual Care (UC) control group or TI. Blood pressure outcomes in both groups will be determined at baseline, 6, 12, 18 and 54 months in an identical and blinded fashion in a research clinic separate from the clinical setting where patients received their medical care. We hypothesize that guideline BP control will be achieved at 6 months and maintained at 12 months in more than 60% of patients from TI clinics, compared to < 40% in patients from UC clinics. We will compare satisfaction with care and costs in the TI and UC groups. The TI has the potential to improve hypertension control for millions of patients, and could be implemented widely in diverse and large patient populations based on performance in this randomized trial. The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hypertension
Intervention  ICMJE Other: Telemonitors and pharmacy management
Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
Study Arms  ICMJE
  • No Intervention: Control
    Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
  • Experimental: Telemonitors and pharmacy management
    The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
    Intervention: Other: Telemonitors and pharmacy management
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2008)
450
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 21 years or more
  • Linked using EMR data to a HealthPartners Medical Group primary care clinic
  • Within the 12-month period of time prior to screening have had at least 2 primary care outpatient encounters, in the two most recent of which the blood pressure was above Joint National Committee 7 (JNC7) goal (<140/90 mmHg or <130/80 for patients with diabetes or kidney disease).
  • Have a measured blood pressure at a research clinic screening visit above the JNC7 goal

Exclusion Criteria:

  • Acute coronary syndrome or stroke within the past 3 months
  • Class III (marked limitation of physical activity) or IV (symptoms at rest) New York Heart Association heart failure, or known left ventricular ejection fraction (<30%)
  • Severe renal dysfunction, with epidermal growth factor receptor (eGFR) ,30 ml/min/1.73 m2 using the abbreviated Modification of Diet in Renal Disease Study (MDRD) equation
  • Known secondary causes of hypertension such as coarctation of the aorta, pheochromocytoma, adrenal cortical hypertension or renal vascular hypertension
  • Unwillingness to be followed for a period of 18 months
  • Pregnancy or unwillingness to use reliable bith control for females of child-bearing age
  • Participation in another clinical trial
  • Requires an interpreter to communicate with health care providers
  • Dementia, mental illness or any condition that would limit ability to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00781365
Other Study ID Numbers  ICMJE 07116
1R01HL090965 ( U.S. NIH Grant/Contract )
2R01HL090965 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party HealthPartners Institute
Study Sponsor  ICMJE HealthPartners Institute
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Karen L Margolis, MD, MPH HealthPartners Institute
PRS Account HealthPartners Institute
Verification Date March 2017

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