UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051356 |
|---|---|
| Receipt number | R000058575 |
| Scientific Title | A descriptive study of patients using digital therapeutics for hypertension in real-world |
| Date of disclosure of the study information | 2023/06/16 |
| Last modified on | 2023/12/13 15:01:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A descriptive study of patients using digital therapeutics for hypertension in real-world
Acronym
A descriptive study of patients using digital therapeutics for hypertension in real-world
Scientific Title
A descriptive study of patients using digital therapeutics for hypertension in real-world
Scientific Title:Acronym
A descriptive study of patients using digital therapeutics for hypertension in real-world
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore suitable clinical apply of the DTx for hypertension, patient backgrounds, app usage, and its therapeutic effect based on real-world data will be investigated.
Basic objectives2
Others
Basic objectives -Others
Characteristics of patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Characteristics of patients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were prescribed and started using the application between September 1, 2022 and April 30, 2023
Key exclusion criteria
Patients who have indicated to CureApp, Inc. that they refuse to provide information
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Tanigawa |
Organization
CureApp, Inc.
Division name
CureApp, Inc.
Zip code
1030001
Address
4F, 12-5, Nihonbashikodenmacho, Chuo-ku, Tokyo, Japan
TEL
0362310183
tomoyuki.tanigawa@cureapp.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hirayama |
Organization
CureApp, Inc.
Division name
Medical Division
Zip code
1030001
Address
4F, 12-5, Nihonbashikodenmacho, Chuo-ku, Tokyo, Japan
TEL
0362310183
Homepage URL
ht_medical-affairs@cureapp.jp
Sponsor or person
Institute
CureApp, Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hillside Clinic Jingumae Ethics Committe
Address
4-22-11 Jingumae, Shibuya-ku, Tokyo
Tel
070-6995-0047
naoki-kitazawa@cmicgroup.com
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 | 06 | Month | 16 | 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
579
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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will enroll adult hypertensive patients receiving treatment with the digital therapeutics from September 2022 to April 2023.
Patients' backgrounds, including age, gender, weight, and blood pressure and its measurement counts, and other app-usage data will be investigated.
Management information
Registered date
| 2023 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058575
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
