Efficacy Determinants of Hypertension Digital Therapeutics: The B-INDEX Study

Digital therapeutics (DTx) for hypertension are among the most promising treatment options, demonstrating proven antihypertensive effects. This study investigates the determinants of the home blood pressure (BP) lowering effect of DTx, using prospectively collected daily data.

The B-INDEX study (Behavioral Modification Index) is a multicenter intervention study in patients with hypertension, involving a 6-month DTx period, followed by an additional 6 months without it. Home BP, body weight and composition, physical activity, and sleep patterns were monitored daily using digital devices. This first report on B-INDEX analyzed data collected during a 6-month DTx treatment period.

A total of 198 patients with hypertension (mean age, 54.9±10.6 years; 57.1% male; mean body mass index, 26.7±5.3 kg/m²; 57.6% taking antihypertensives) were included in the analysis. A marked reduction in BP was observed in the first 4 weeks (morning home BP, -6.2/-2.6 mm Hg). Mixed model analysis demonstrated that baseline home BP, older age, self-efficacy score, reduction in self-reported salt intake, and mild initial weight loss (-0.5 kg at week 4) were significant determinants of home BP reduction at 6 months.

Older age, salt reduction, and initial weight loss were predictive factors for effective BP reduction through DTx, independent of baseline BP values. We propose that the first 4 weeks are the key period for hypertension treatment with DTx.

URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000050479.