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Behavioral modification INDEX using digital therapeutics Study

Behavioral modification INDEX using digital therapeutics Study (Behavioral-INDEX study) - B-INDEX Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050479
Enrollment
200
Registered
2023-03-10
Start date
2023-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Participants will receive digital therapeutics for hypertension using the &quot
CureApp HT&quot
app. for 6 months, which is an interactive support for intensive and consistent lifestyle modifications.

Sponsors

Jichi Medical University School of Medicine
Lead Sponsor
CureApp, Inc. A&amp
Collaborator
D, Co.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all the following criteria will be eligible for this study. 1)Patients with essential hypertension who are 20 years old or older. 2)Morning and/or evening SBP at home >=135mmHg and/or morning and/or evening DBP at home >=85mmHg. (Confirmed at the time of temporary enrollment and study registration visits). 3) Patients who use some kind of smartphone application on a daily basis. 4) Patients who have never used "CureApp HT".

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria are excluded in this study. 1) Patients with office SBP>=180 mmHg and/or office DBP>=110 mmHg 2) Patients with a diagnosis of primary aldosteronism, renovascular hypertension, pheochromocytoma, or drug-induced hypertension 3) Patients with suspected renal dysfunction (creatinine >= 1.8 mg/dL) 4) Patients who have difficulty wearing the wristband at all times during the day and while sleeping 5) Patients with pacemakers or other medical electrical devices implanted in the body 6) Patients undergoing treatment for cancer, collagen disease, or other serious illness

Design outcomes

Primary

MeasureTime frame
Relationship between the home BP change and the changes of measurements by ICT devices (objective assessments of lifestyle behavioral modification) after the initiation of the digital therapeutics using the "CureApp HT" app.

Secondary

MeasureTime frame
After the initiation of the digital therapeutics using the "CureApp HT", 1) Relationship between the change of home BP and self-reported diary and questionnaire (subjective assessments of lifestyle behavioral modification). 2) Relationship between the objective assessments and subjective assessments of lifestyle behavioral modification 3) Effects of various indexes of lifestyle behavioral modification on BP reduction. 4) Effects of individual characteristics on BP reduction 5) Interaction between lifestyle behavioral modification indexes and individual characteristics on BP reduction 6) Persistence and acquirement of improved lifestyle 7) Persistence of BP-lowering effect

Countries

Japan

Contacts

Public ContactKazuomi Kario

Jichi Medical University School of Medicine Division of Cardiovascular Medicine, Department of Medicine

kkario@jichi.ac.jp+81285587538

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 9, 2026