Patients with high blood pressure (BP) visit a physician 4 times or more per year on average in the U.S., yet BP is controlled in only about half. Practical, robust and sustainable models are needed to improve BP control in patients with uncontrolled hypertension.
To determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention stops.
A clinic-randomized trial with 12 months of intervention and 6 months of post-intervention follow-up.
Patients and Setting
450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across sixteen primary care clinics in an integrated health system in Minneapolis-St. Paul, MN.
Eight clinics were randomized to provide usual care to their patients (n = 222) and 8 were randomized to provide the telemonitoring intervention (n = 228). Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly.
Main Outcome Measures
BP control to <140/90 mm Hg (<130/80 mm Hg in patients with diabetes or kidney disease) at 6 and 12 months. Secondary outcomes were change in BP, patient satisfaction, and BP control at 18 months.
At baseline, enrollees were 45% female, 82% non-Hispanic white, mean age was 61 (sd 12.0) years and mean BP was 148/85 mm Hg. BP was controlled at both 6 and 12 months in 57.2% (95% CI, 44.8% - 68.7%) of Telemonitoring Intervention patients and 30.0% (95% CI, 23.2% - 37.8%) of Usual Care patients, P=0.001. At 6 months, BP was controlled in 71.8 % (95% CI, 65.6% - 77.3%) of Telemonitoring Intervention patients and 45.2% (95% CI, 39.2% - 51.3%) of Usual Care patients, P<0.0001; at 12 months BP was controlled in 71.2% (95% CI, 62.0% - 78.9%) of Telemonitoring Intervention patients and 52.8% (95% CI, 45.4% - 60.2%) of Usual Care patients, P=0.005; and at 18 months BP was controlled in 71.8% (95% CI, 65.0% - 77.8%) of Telemonitoring Intervention patients and 57.1% (95% CI, 51.5% - 62.6%) of Usual Care patients, P=0.003. Systolic BP decreased from baseline more among Telemonitoring Intervention than Usual Care patients by 10.7 mm Hg (95% CI, 7.3-14.3) at 6 months, 9.7 mm Hg (95% CI, 6.0-13.4) at 12 months, and 6.6 mm Hg (95% CI, 2.5-10.7) at 18 months, all P<0.001. Diastolic BP decreased from baseline more among Telemonitoring Intervention than Usual Care patients by 6.0 mm Hg (95% CI, 3.4-8.6) at 6 months, 5.1 mm Hg (95% CI, 2.8-7.4) at 12 months, and 3.0 mm Hg (95% CI, -0.3-6.3) at 18 months, all P<0.001, except at 18 months.
Home BP telemonitoring and pharmacist case management achieved better BP control compared to usual care during 12 months of intervention, and benefits persisted for 6 months post-intervention.
ClinicalTrials.gov, NCT00781365. URL: http://clinicaltrials.gov/ct2/show/NCT00781365?term=hyperlink&rank=1