UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052169 |
|---|---|
| Receipt number | R000059539 |
| Scientific Title | A retrospective cohort study of digital therapeutics for hypertension. |
| Date of disclosure of the study information | 2023/09/11 |
| Last modified on | 2023/10/13 17:45:10 |
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Basic information
Public title
A retrospective cohort study of digital therapeutics for hypertension.
Acronym
A retrospective cohort study of digital therapeutics for hypertension.
Scientific Title
A retrospective cohort study of digital therapeutics for hypertension.
Scientific Title:Acronym
A retrospective cohort study of digital therapeutics for hypertension.
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide insights leading to the optimal utilization of the digital therapeutics for hypertension, by investigating the real-world effectiveness and related factors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in home blood pressure at 12 weeks of app use
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients who were prescribed CureApp HT between September 2022 and December 2025 and input their home blood pressure at least once.
Key exclusion criteria
- Patients who have indicated their refusal to provide information to the institutions of this study
- Nonexistent data such as input for testing
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
College of Transdisciplinary Sciences for Innovation / Department of Cardiovascular Medicine
Zip code
920-1192
Address
Kakuma-machi, Kanazawa City, Ishikawa
TEL
076-264-5920
anomura@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Nomura |
Organization
Kanazawa University
Division name
College of Transdisciplinary Sciences for Innovation / Department of Cardiovascular Medicine
Zip code
920-1192
Address
Kakuma-machi, Kanazawa City, Ishikawa
TEL
076-264-5920
Homepage URL
anomura@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
CureApp, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committe of Kanazawa University
Address
Kakuma-machi, Kanazawa City, Ishikawa
Tel
076-265-2110
rinri@adm.kanazawa-u.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 | 09 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2023 | Year | 09 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059539
