Trial reportJournal of clinical hypertension (Greenwich, Conn.)2021
Digital therapeutics for essential hypertension using a smartphone application: A randomized, open-label, multicenter pilot study.
Trial report in Journal of clinical hypertension (Greenwich, Conn.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Smartphone Apps for Cardiovascular and Mental Health Care: Digital Cross-Sectional Analysis.JMIR mHealth and uHealth · 2025Pooled it
- Smartphone-Based Digital Health Interventions: A Comprehensive Systematic Review of Efficacy for Cardiovascular and Cerebrovascular Outcomes.Journal of medical systems · 2025Pooled it
- Behavior Change Techniques Used in Self-Management Interventions Based on mHealth Apps for Adults With Hypertension: Systematic Review and Meta-Analysis of Randomized Controlled Trials.Journal of medical Internet research · 2024Pooled it
- Efficacy and safety of digital therapeutics-based cardiac rehabilitation in heart failure patients: a systematic review.ESC heart failure · 2022Pooled it
- Evaluating the Efficacy of a Digital Therapeutic Intervention for Temporomandibular Disorders: Multicenter, Randomized, Sham-Controlled Trial.Journal of medical Internet research · 2025Trial
- The effects of a digital lifestyle intervention in patients with hypertension: Results of a pilot randomized controlled trial.Journal of clinical hypertension (Greenwich, Conn.) · 2024Trial
- Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial.European heart journal · 2021Trial
- Digital therapeutics for essential hypertension using a smartphone application: A randomized, open-label, multicenter pilot study.Journal of clinical hypertension (Greenwich, Conn.) · 2021Trial
- Digital health technologies in medicine: evidence, artificial intelligence integration, and ethical challenges.Infectious agents and cancer · 2026Review
- Self-Management Combined With Digital Health Interventions to Improve Dietary Behavior, Exercise Behavior, Stress Management Behavior, and Blood Pressure Among Thais With Uncontrolled Hypertension: Protocol for an Explanatory Sequential Study.JMIR research protocols · 2026Article
- Digital therapeutics use burden in patients with chronic diseases: a scoping review.Frontiers in public health · 2026Article
- Network meta analysis of contributions by different healthcare practitioners in digital self care for hypertension.NPJ digital medicine · 2025Review
- Editorial: The Role of Telemedicine in Transforming Healthcare Delivery-Capabilities and Barriers.Healthcare (Basel, Switzerland) · 2025Article
- Clinical Decision Support Systems Using Home Blood Pressure Readings to Manage Patients With Hypertension: Scoping Review.Journal of medical Internet research · 2025Article
- Efficacy and cost-effectiveness of digital health interventions in improving hypertensive outcomes among patients with uncontrolled hypertension: A systematic review.International journal of nursing sciences · 2025Review
- Digital therapeutics in hypertension: How to make sustainable lifestyle changes.Journal of clinical hypertension (Greenwich, Conn.) · 2024Review
- Digital hypertension towards to the anticipation medicine.Hypertension research : official journal of the Japanese Society of Hypertension · 2023Review
- Real-World Evidence of a Hospital-Linked Digital Health App for the Control of Hypertension and Diabetes Mellitus in South Korea: Nationwide Multicenter Study.JMIR formative research · 2023Article
- Effects of Customized Digital Health Care Service on Metabolic Syndrome Status and Lifestyle Using a Health Care App: Clinical Trial.JMIR formative research · 2023Article
- Automatic transmission of home blood pressure data can be effective in managing hypertension: a systematic review and meta-analysis.European heart journal. Digital health · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Hypertension is the most considerable but treatable risk factor for cardiovascular disease. Although physicians prescribe multiple antihypertensive drugs and promote lifestyle modifications, the real-world blood pressure (BP) control rate remains poor. To improve BP target achievement, we developed a novel digital therapeutic-the HERB software system -to manage hypertension. Here, we performed a randomized pilot study to assess the safety and efficacy of the HERB system for hypertension. We recruited 146 patients with essential hypertension from March 2018 to March 2019. We allocated eligible patients to the intervention group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary outcome was the mean change from baseline to 24 weeks in 24-hour systolic BP (SBP) measured by ambulatory blood pressure monitoring (ABPM). The baseline characteristics in each group were well balanced; the mean age was approx. 57 years, and 67% were male. In the primary end point at 24 weeks, HERB intervention did not lower the mean change of 24-hour SBP by ABPM compared with the controls (adjusted difference: -0.66 mmHg; p = .78). In an exploratory analysis focusing on antihypertensive drug-naïve patients aged <65, the effects of the HERB intervention were significantly greater than the control for reducing 24-hour SBP by ABPM at 16 weeks (adjusted difference: -7.6 mmHg; p = .013; and morning home SBP at 24 weeks (adjusted difference - 6.0 mmHg; p = .012). Thus, the HERB intervention did not achieve a primary efficacy end point. However, we observed that antihypertensive drug-naïve adult hypertensive patients aged <65 years could be a potential HERB system-effective target for further investigations of the efficacy of the system.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.