Background <p>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 <i>liebria</i>, an internet-based digital intervention accessible via smartphones and computers, designed to support the self-management of hypertension.</p> Methods <p>We tested the effectiveness of <i>liebria</i> 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 <i>liebria</i> in addition to treatment as usual (<i>n</i> = 52), or treatment as usual alone (<i>n</i>=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.</p> Results <p>The study's statistical power was limited due to a smaller sample size (<i>N</i> = 102) than the a priori target sample size (<i>N</i>=676). Intention-to-treat analyses showed an effect of <i>liebria</i> on systolic blood pressure (baseline-adjusted between-group difference -3.5 mmHg, 95% CI -7.13 to 0.13, <i>p</i> = .053, Cohen’s <i>d</i> = 0.36). More participants in the intervention group (78.2% vs. 54.3% in the control group) showed reductions in systolic blood pressure (<i>p</i> = .076). Moreover, <i>liebria</i> 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.</p> Conclusions <p>The present study shows first promising results of <i>liebria</i>’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.</p> Trial registration <p>German Clinical Trials Register (DRKS00025871); <a href="https://drks.de/search/en/trial/DRKS00025871">https://drks.de/search/en/trial/DRKS00025871</a>; date of registration: October 5, 2021.</p>

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

  • Björn Meyer,
  • Antje Riepenhausen,
  • Linda T. Betz,
  • Kamila Jauch-Chara,
  • Alexander Reshetnik

摘要

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.