UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060168 |
|---|---|
| Receipt number | R000068809 |
| Scientific Title | Survey on How the Implementation of a Hypertension Digital Therapeutic in Medical Facilities Affects Patients' Healthcare Utilization |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/22 19:35:15 |
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Basic information
Public title
Survey on How the Implementation of a Hypertension Digital Therapeutic in Medical Facilities Affects Patients' Healthcare Utilization
Acronym
Survey on How the Implementation of a Hypertension Digital Therapeutic in Medical Facilities Affects Patients' Healthcare Utilization
Scientific Title
Survey on How the Implementation of a Hypertension Digital Therapeutic in Medical Facilities Affects Patients' Healthcare Utilization
Scientific Title:Acronym
Survey on How the Implementation of a Hypertension Digital Therapeutic in Medical Facilities Affects Patients' Healthcare Utilization
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the impact of introducing the therapeutic SaMD (CureApp HT) on patient treatment behavior, specifically new visits and follow-up visits, at the healthcare institution implementing it.
Basic objectives2
Others
Basic objectives -Others
questionnaire survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Not applicable
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Questionnaire A (General Hypertension Patients):Adult hypertension patients who meet the diagnostic criteria for hypertension and are currently receiving treatment at a medical institution or have received treatment in the past.
Survey B (Hypertension Patients Using SaMD):Currently undergoing hypertension treatment using CureApp HT and has received guidance from a physician at least once based on their own input.
Key exclusion criteria
Survey A (General Hypertension Patients):Patients who have received treatment with CureApp HT in the past or currently.
Survey B (Hypertension Patients Using SaMD):-
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Tanigawa |
Organization
CureApp, Inc.
Division name
Medical Division
Zip code
1030001
Address
4F, 12-5, Nihonbashikodenmacho, Chuo-ku, Tokyo, Japan
TEL
0362310183
ht_medical-affairs@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
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
Self funding
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of St. Luke's International University
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
03-5550-2423
kenkyukikaku@luke.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
| 2025 | Year | 12 | Month | 22 | 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
| 2025 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the extent to which the introduction of therapeutic SaMD influences preferences when hypertensive patients select medical institutions, we will conduct an online survey targeting two distinct patient groups. This survey aims to identify treatment-seeking behaviors during initial and follow-up visits, specifically focusing on the factors patients prioritize when choosing a medical institution.
Management information
Registered date
| 2025 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068809
