Effects of self-monitoring devices on blood pressure in older adults with hypertension and diabetes: a randomised controlled trial

BACKGROUND: Hypertension and diabetes frequently coexist, which results in the difficulty of hypertension control in community-dwelling elderly adults who lack effective prevention and control strategies. The aim of this study is to determine whether a combined pedometer and home blood pressure monitoring (HBPM) programme could improve blood pressure (BP) among community-dwelling elderly adults with hypertension and diabetes. METHODS: The trial was a 2×2 factorial randomised clinical trial that recruited 180 community-dwelling elderly people (aged ≥60) with hypertension and diabetes in Tianjin, China. Participants were randomly assigned to control, pedometer, HBPM, and pedometer+HBPM groups. Intervention period was 12 months. The coprimary outcomes of the study were systolic and diastolic BP; the secondary outcomes included the proportion of patients with controlled hypertension. BP was measured twice in the right arm using a mercurial sphygmomanometer. The mean of these two measurements was taken as the BP value. RESULTS: At 12 months, compared with the control group, the adjusted differences in least squares mean (95% CI) in systolic and diastolic BP changes for pedometer, HBPM, and pedometer+HBPM groups were -4.2 (-8.4 to 0.1), -2.7 (-6.9 to 1.5) and -8.1 (-12.3 to -3.9) mm Hg (p<0.01); -3.2 (-5.2 to -1.1), -0.1(-2.1 to 1.9) and -3.6 (-5.6 to -1.5) mm Hg (p<0.001), respectively; the adjusted difference in percentage (95% CI) in the controlled hypertension (BP <140/90 mm Hg) for pedometer, HBPM and pedometer+HBPM groups were 7.5 (-12.2 to 27.1), 9.9 (-10.4 to 30.3) and 23.1 (5.0 to 41.1) (p=0.09). CONCLUSION: Combination pedometer and HBPM interventions can significantly decrease BP levels in elderly adults with hypertension and diabetes. TRIALS REGISTRATION NUMBER: UMIN000021613.