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Home Blood Pressure Telemonitoring and Case Management to Control Hypertension

Home Blood Pressure Telemonitoring and Case Management to Control Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00781365
Acronym
Hyperlink
Enrollment
450
Registered
2008-10-29
Start date
2009-03-31
Completion date
2012-10-31
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Telemonitoring, Pharmacy management

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.

Interventions

OTHERTelemonitors 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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
HealthPartners Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure ControlBaseline, 6 months, 12 months, 18 monthsPercentage 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 PressureBaseline, 6 months, 12 months, 18 months, 54 monthsSystolic blood pressure at baseline and 4 time points
Mean Diastolic Blood PressureBaseline, 6 months, 12 months, 18 months, 54 monthsMean diastolic blood pressure at baseline and 4 time points

Countries

United States

Participant flow

Recruitment details

Recruitment was between March 2009-April 2011. We identified adult patients with elevated BP (systolic BP \>140 or diastolic BP \>90 mm Hg) at the two most recent primary care visits in the past year using electronic medical records. Patients received up to two mailings followed by phone calls. Further screening occurred in research clinic.

Pre-assignment details

Participants were assigned to treatment group based on their primary care clinic location. Clinics were randomized to treatment or control (cluster randomization).

Participants by arm

ArmCount
Usual Care
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
222
Telemonitoring Intervention
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. 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.
228
Total450

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDid Not Attend Visit2028
Overall StudyLanguage barrier10
Overall StudyWithdrawal by Subject138

Baseline characteristics

CharacteristicTotalUsual CareTelemonitoring Intervention
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
151 Participants70 Participants81 Participants
Age, Categorical
Between 18 and 65 years
299 Participants152 Participants147 Participants
Age, Continuous61.1 years
STANDARD_DEVIATION 12
60.2 years
STANDARD_DEVIATION 12.2
62.0 years
STANDARD_DEVIATION 11.7
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants9 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
440 Participants213 Participants227 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
7 participants3 participants4 participants
Race/Ethnicity, Customized
Black or African American
53 participants29 participants24 participants
Race/Ethnicity, Customized
Other
22 participants13 participants9 participants
Race/Ethnicity, Customized
White
368 participants177 participants191 participants
Sex: Female, Male
Female
201 Participants98 Participants103 Participants
Sex: Female, Male
Male
249 Participants124 Participants125 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
8 / 2225 / 228
serious
Total, serious adverse events
37 / 22230 / 228

Outcome results

Primary

Blood Pressure Control

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)

Time frame: Baseline, 6 months, 12 months, 18 months

ArmMeasureGroupValue (NUMBER)
Usual CareBlood Pressure ControlBaseline0 percentage of participants
Usual CareBlood Pressure Control6 Months45.2 percentage of participants
Usual CareBlood Pressure Control12 Months52.8 percentage of participants
Usual CareBlood Pressure Control18 Months57.1 percentage of participants
Telemonitoring InterventionBlood Pressure Control18 Months71.8 percentage of participants
Telemonitoring InterventionBlood Pressure ControlBaseline0 percentage of participants
Telemonitoring InterventionBlood Pressure Control12 Months71.2 percentage of participants
Telemonitoring InterventionBlood Pressure Control6 Months71.8 percentage of participants
Primary

Mean Diastolic Blood Pressure

Mean diastolic blood pressure at baseline and 4 time points

Time frame: Baseline, 6 months, 12 months, 18 months, 54 months

ArmMeasureGroupValue (MEAN)
Usual CareMean Diastolic Blood PressureBaseline85.1 mm Hg
Usual CareMean Diastolic Blood Pressure12 Months80.8 mm Hg
Usual CareMean Diastolic Blood Pressure54 Months79.1 mm Hg
Usual CareMean Diastolic Blood Pressure18 Months78.7 mm Hg
Usual CareMean Diastolic Blood Pressure6 Months81.7 mm Hg
Telemonitoring InterventionMean Diastolic Blood Pressure54 Months77.8 mm Hg
Telemonitoring InterventionMean Diastolic Blood PressureBaseline84.4 mm Hg
Telemonitoring InterventionMean Diastolic Blood Pressure6 Months75.0 mm Hg
Telemonitoring InterventionMean Diastolic Blood Pressure12 Months75.1 mm Hg
Telemonitoring InterventionMean Diastolic Blood Pressure18 Months75.1 mm Hg
Primary

Mean Systolic Blood Pressure

Systolic blood pressure at baseline and 4 time points

Time frame: Baseline, 6 months, 12 months, 18 months, 54 months

ArmMeasureGroupValue (MEAN)
Usual CareMean Systolic Blood Pressure6 Months136.9 mmHg
Usual CareMean Systolic Blood Pressure18 Months133.0 mmHg
Usual CareMean Systolic Blood Pressure12 Months134.8 mmHg
Usual CareMean Systolic Blood Pressure54 Months131.7 mmHg
Usual CareMean Systolic Blood PressureBaseline147.7 mmHg
Telemonitoring InterventionMean Systolic Blood Pressure54 Months131.2 mmHg
Telemonitoring InterventionMean Systolic Blood PressureBaseline148.2 mmHg
Telemonitoring InterventionMean Systolic Blood Pressure6 Months126.7 mmHg
Telemonitoring InterventionMean Systolic Blood Pressure12 Months125.7 mmHg
Telemonitoring InterventionMean Systolic Blood Pressure18 Months126.9 mmHg

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026