Home Blood Pressure Telemonitoring and Case Management to Control Hypertension

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electronic Communications and Home Blood Pressure Monitoring

NCT00158639

Hypertension

COMPLETED PHASE3

Hypertension Intervention Nurse Telemedicine Study (HINTS)

NCT00237692

Hypertension

COMPLETED NA

Comparison of Telemedical and Conventional Treatment of Hypertension

NCT02531347

Hypertension

COMPLETED NA

Team-Based Home Blood Pressure Monitoring

NCT05488795

High Blood Pressure Hypertension

ACTIVE_NOT_RECRUITING NA

Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

NCT00921791

Hypertension

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Telemonitors and pharmacy management

Intervention Type OTHER

Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes