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Randomized Controlled Trial
. 2025 Apr 4;25(1):256.
doi: 10.1186/s12872-025-04698-5.

Internet-based digital intervention to support the self-management of hypertension compared to usual care: results of the HALCYON randomized controlled trial

Björn Meyer  1 , Antje Riepenhausen  2 , Linda T Betz  2 , Kamila Jauch-Chara  3 , Alexander Reshetnik  4
Affiliations
Randomized Controlled Trial

Internet-based digital intervention to support the self-management of hypertension compared to usual care: results of the HALCYON randomized controlled trial

Björn Meyer et al. BMC Cardiovasc Disord. .

Abstract

Background: Hypertension is a major public health problem. Despite existing treatment options, overall blood pressure control is still insufficient. Digital health interventions have the potential to improve treatment success. We developed liebria, an internet-based digital intervention accessible via smartphones and computers, designed to support the self-management of hypertension.

Methods: We tested the effectiveness of liebria in reducing systolic blood pressure and improving other relevant endpoints in adults with hypertension using a parallel randomized controlled trial design. Adults with hypertension (mean age 54.5 years, 47.1% male) were recruited via a German health insurance provider and randomized (1:1; concealed allocation; no blinding of participants) to receive liebria in addition to treatment as usual (n = 52), or treatment as usual alone (n=50). Primary outcome was systolic blood pressure after 3 months (T1). Secondary endpoints were diastolic blood pressure, pulse pressure, quality of life, medication adherence, and social and work-related functioning.

Results: The study's statistical power was limited due to a smaller sample size (N = 102) than the a priori target sample size (N=676). Intention-to-treat analyses showed an effect of liebria on systolic blood pressure (baseline-adjusted between-group difference -3.5 mmHg, 95% CI -7.13 to 0.13, p = .053, Cohen's d = 0.36). More participants in the intervention group (78.2% vs. 54.3% in the control group) showed reductions in systolic blood pressure (p = .076). Moreover, liebria had effects on social and work-related functioning. No effects emerged for diastolic blood pressure, pulse pressure, quality of life, or medication adherence. No adverse events or device effects were observed.

Conclusions: The present study shows first promising results of liebria's effects on systolic blood pressure and social and work-related functioning. Future studies should aim to replicate effects in a larger sample to increase statistical power.

Trial registration: German Clinical Trials Register (DRKS00025871); https://drks.de/search/en/trial/DRKS00025871 ; date of registration: October 5, 2021.

Keywords: Behavioral change; Cognitive behavioral therapy; Digital intervention; Hypertension; RCT.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was approved by the ethics committee of the medical faculty at the Christian-Albrechts-Universität zu Kiel (D 560/21). Participants provided informed consent to participate. Consent for publication: Not applicable. Competing interests: BM, A Riepenhausen and LB are employees of GAIA, the developer, owner, and distributor of liebria. A Reshetnik is a clinical advisor to GAIA and received consultancy fees.

Figures

Fig. 1
Fig. 1
Study Flow Chart. Note: TAU = treatment as usual
See this image and copyright information in PMC

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