Behavioral modification INDEX using digital therapeutics Study
Not Applicable
Recruiting
- Conditions
- Hypertension
- Registration Number
- JPRN-UMIN000050479
- Lead Sponsor
- Jichi Medical University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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