Evidence map›Paper›PMID 32815648›Full record

ArticleJournal of clinical hypertension (Greenwich, Conn.)2020

A multicenter clinical trial to assess the efficacy of the digital therapeutics for essential hypertension: Rationale and design of the HERB-DH1 trial.

Kazuomi Kario, Akihiro Nomura, Noriko Harada, Tomoyuki Tanigawa, Ryuhei So, Kiyose Nakagawa, Shin Suzuki, Ayako Okura, Eisuke Hida, Kohta Satake

Open access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of clinical hypertension (Greenwich, Conn.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Home blood pressure-lowering effect of digital therapeutics in hypertension: impact of body weight and salt intake.Hypertension research : official journal of the Japanese Society of Hypertension · 2023
    Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Adoption of Digital Therapeutics in Europe.Therapeutics and clinical risk management · 2024
    Review
  10. Digital hypertension towards to the anticipation medicine.Hypertension research : official journal of the Japanese Society of Hypertension · 2023
    Review
  11. Cost-effectiveness of digital therapeutics for essential hypertension.Hypertension research : official journal of the Japanese Society of Hypertension · 2022
    Article
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 3 countries.

Kazuomi KarioDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.ORCID 0000-0002-8251-4480
Akihiro NomuraCureApp Institute, Karuizawa, Japan.
Noriko HaradaDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.
Tomoyuki TanigawaCureApp Institute, Karuizawa, Japan.
Ryuhei SoCureApp, Inc, Tokyo, Japan.
Kiyose NakagawaCureApp, Inc, Tokyo, Japan.
Shin SuzukiCureApp, Inc, Tokyo, Japan.
Ayako OkuraDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.
Eisuke HidaDepartment of Biostatistics and Data Science, Osaka University Graduate School of Medicine, Osaka, Japan.
Kohta SatakeCureApp Institute, Karuizawa, Japan.
Institute for Development and Economic Analysis · IDJichi Medical University · JPJapanese Red Cross Medical Center · JPKanazawa University · JPThe University of Osaka · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Digital therapeutics is a new approach to treat hypertension via using software programs such as smartphone apps and/or device algorithms. We develop a HERB system-new interactive smartphone app (HERB Mobile) with web-based patient management console (HERB Console)-to lower blood pressure (BP) based on an algorithm that helps users to promote lifestyle modifications in conjunction with medically validated non-pharmacological interventions. The app can assess the personalities, behavior characteristics, and hypertension determinants of each patient with hypertension to provide adequate guidance. To demonstrate the efficacy of the system, we designed a randomized, controlled, multicenter, open-label trial "HERB-DH1 (HERB digital hypertension 1)" to assess the efficacy of HERB system in patients with essential hypertension. The authors allocate patients to the intervention group (HERB system + standard lifestyle modification) or to the control group (standard lifestyle modification alone). In the intervention group, we provide the HERB Mobile for patients and the HERB Console for their primary physicians for 24 weeks. Both groups are instructed for standard lifestyle modifications based on the current recommendations in the Japanese Society of Hypertension 2019 guideline. The primary outcome is the mean change from baseline to 12 weeks in 24-hour systolic BP measured by ambulatory BP monitoring. We started this study in December of 2019, and the trial results will be expected in early 2021. We believe that this trial enables us to verify the efficacy of the HERB system in patients with essential hypertension.

Indexed as

Essential HypertensionBlood PressureBlood Pressure Monitoring, AmbulatoryFemaleHumansLife StyleMulticenter Studies as TopicPregnancyRandomized Controlled Trials as Topicdigital therapeuticshypertensionlifestyle modificationmobile applicationsrandomized controlled trials

Identifiers

PMID32815648
PMCPMC7589405
OpenAlexW3080400117

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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 Socratic graph.