N/A
N=450
Home Blood Pressure Telemonitoring and Case Management to Control Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00781365 ↗Enrolled (actual)
450
Serious AEs
14.9%
Results posted
Jul 2014
Primary outcome: Primary: Blood Pressure Control — 0; 0; 45.2; 71.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telemonitors and pharmacy management (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure Control |
0; 0; 45.2; 71.8; 52.8; 71.2 | — |
| PRIMARY Mean Systolic Blood Pressure |
147.7; 148.2; 136.9; 126.7; 134.8; 125.7 | — |
| PRIMARY Mean Diastolic Blood Pressure |
85.1; 84.4; 81.7; 75.0; 80.8; 75.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00781365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.