UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057503 |
|---|---|
| Receipt number | R000065351 |
| Scientific Title | A pilot study on the development of software applications for preventive medicine |
| Date of disclosure of the study information | 2025/04/03 |
| Last modified on | 2026/04/05 06:10:22 |
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Basic information
Public title
A pilot study on the development of software applications for preventive medicine
Acronym
A pilot study on the development of software applications for preventive medicine
Scientific Title
A pilot study on the development of software applications for preventive medicine
Scientific Title:Acronym
A pilot study on the development of software applications for preventive medicine
Region
| Japan |
Condition
Condition
coronary artery disease, chronic heart failure, healthy individuals
Classification by specialty
| Medicine in general | Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to validate the feasibility of a smartphone application that promotes monitoring daily health status. This is effective in preventing the onset and progression of cardiovascular diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lipids (LDL/HDL cholesterol, triglycerides)
Blood pressure (systolic blood pressure, diastolic blood pressure)
Body composition (weight, muscle mass, body fat mass, water content)
Ankle Brachial Index (ABI)
Cardio-Ankle Vascular Index (CAVI)
Key secondary outcomes
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A smrtphone application
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
Cohort (1) eligibility criteria:
(1) Patients with coronary artery disease or chronic heart failure (Stage B-C).
(2) Individuals deemed suitable for participation by their primary physician.
Cohort (2) eligibility criteria:
(1) Age 18 or older.
(2) Individuals who own a smartphone (iPhone) and a wearable device (such as an Apple Watch).
Key exclusion criteria
1. Individuals who have difficulty using a smartphone or wearable device.
2. Individuals deemed ineligible by their primary physician.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Nochioka |
Organization
Tohoku University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
9808574
Address
Seiryo-machi 1-1, Aobaku Sendai, Miyagi Japan
TEL
+81227177153
kotaro.nochioka.d5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Nochioka |
Organization
Tohoku University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
9808574
Address
Seiryo-machi 1-1, Aobaku Sendai
TEL
+81227177153
Homepage URL
kotaro.nochioka.d5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
NEC Solution Innovators, Ltd.
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
+8122-728-4105
ec-med@grp.tohoku.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 | 04 | Month | 03 | 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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065351
