UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050479 |
|---|---|
| Receipt number | R000057497 |
| Scientific Title | Behavioral modification INDEX using digital therapeutics Study (Behavioral-INDEX study) |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2025/06/06 11:54:09 |
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Basic information
Public title
Behavioral modification INDEX using digital therapeutics Study
Acronym
B-INDEX Study
Scientific Title
Behavioral modification INDEX using digital therapeutics Study (Behavioral-INDEX study)
Scientific Title:Acronym
B-INDEX Study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between subjective and objective assessments of lifestyle behavioral modification and antihypertensive effects after the initiation of the digital therapeutics using the "CureApp HT" app.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will receive digital therapeutics for hypertension using the "CureApp HT" app. for 6 months, which is an interactive support for intensive and consistent lifestyle modifications.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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".
Key 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
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
3200498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
+81285587538
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
+81285587538
Homepage URL
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
CureApp, Inc.
A&D, Co.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Bioethics Committee for Clinical Research
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
Tel
81285588933
rinri@jichi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057497
