Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (Hyperlink)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00781365 |
Recruitment Status :
Completed
First Posted : October 29, 2008
Results First Posted : July 14, 2014
Last Update Posted : April 13, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Other: Telemonitors and pharmacy management | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 450 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Home Blood Pressure Telemonitoring and Case Management to Control Hypertension |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
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No Intervention: Control
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
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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.
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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. |
- 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

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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): NCT00781365
United States, Minnesota | |
HealthPartners Institute | |
Minneapolis, Minnesota, United States, 55440 |
Principal Investigator: | Karen L Margolis, MD, MPH | HealthPartners Institute |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | HealthPartners Institute |
ClinicalTrials.gov Identifier: | NCT00781365 |
Other Study ID Numbers: |
07116 1R01HL090965 ( U.S. NIH Grant/Contract ) 2R01HL090965 ( U.S. NIH Grant/Contract ) |
First Posted: | October 29, 2008 Key Record Dates |
Results First Posted: | July 14, 2014 |
Last Update Posted: | April 13, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Hypertension Telemonitoring Pharmacy management |
Hypertension Vascular Diseases Cardiovascular Diseases |