Efficacy of a home blood pressure monitoring programme on therapeutic compliance in hypertension:: the EAPACUM-HTA study

Objective To evaluate the efficacy of a programme of home blood pressure measurement (HBPM) on therapeutic compliance in mild-to-moderate hypertension. Design A prospective controlled multicentre clinical trial. Setting Forty primary care centres in Spain, with a duration of 6 months. Patients A total of 250 patients with newly diagnosed or uncontrolled hypertension were included. Interventions The patients were randomly selected and distributed in two groups: (1) the control group (CG) who received standard health intervention; (2) the intervention group (IG): the patients in this group received an OMRON in their homes for a programme of HBPM. Main outcome measure Four visits were scheduled, for the measurement of blood pressure (BP). They were provided with an electronic monitor for measuring compliance (monitoring events medication system; MEMS). Therapeutic compliance was defined as a drug consumption of 80-110%. A number of variables were calculated using the MEMS. The mean BP were calculated and the percentage of controlled patients. Results A total of 200 patients completed the study (100 in each group). Compliance was observed in 74 and 92%, respectively, in the CG and IG [95% confidence interval (CO 63.9 -84.1 and 86.7 - 97.3; P = 0.0001], the mean percentage compliances were 87.6 and 93.5% (95% Cl 81.2-94 and 80.7-98.3; P = 0.0001), the percentages of correct days were 83.6 and 89.4%, the percentages of subjects who took the medication at the prescribed time were 79.89 and 88.06%, and the levels of therapeutic cover were 86.7 and 93.1%. The number needed to treat to avoid one case of non-compliance was 5.6 patients. The differences in the mean decreases in BP were significant for diastolic BP, with a greater decrease observed in the IG. Conclusions An HBPM programme using electronic monitors is effective in improving compliance in arterial hypertension, measured using the MEMS.