UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054560 |
|---|---|
| Receipt number | R000062258 |
| Scientific Title | Evaluation of effectivity of accompanying type intervention by using FonesVisuas, the future disease risk prediction service |
| Date of disclosure of the study information | 2024/06/04 |
| Last modified on | 2025/04/23 09:13:34 |
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Basic information
Public title
Evaluation of effectivity of accompanying type intervention by using FonesVisuas, the future disease risk prediction service
Acronym
Evaluation of effectivity of accompanying type intervention by using FonesVisuas, the future disease risk prediction service
Scientific Title
Evaluation of effectivity of accompanying type intervention by using FonesVisuas, the future disease risk prediction service
Scientific Title:Acronym
Evaluation of effectivity of accompanying type intervention by using FonesVisuas, the future disease risk prediction service
Region
| Japan |
Condition
Condition
Dementia, Heart failure, Stroke, Lung cancer, Chronic Kidney Disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
FonesVisuas, the future disease risk prediction service will be used to evaluate of effectivity of accompanying type intervention(*).
It will be carried out for three months.
We will use the test results of the FonesVisuas test to be done before the intervention and the one being done after the intervention.
Using these test results, we will see the degree of change for the Group 1 and Group 2, in terms of
the number of participants or the predictive risk ratio.
(*) Accompany type intervention:
The intervention accompanying a participant to help him/her achieve the goal of lifestyle modification.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FonesVisuas Test results, predictive risk ratio of the following diseases
-Dementia, within twenty years
-Stroke, heart failure within four years
-Lung cancer, within five yearrs
-Chronic Kidney Disease, within four years
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
30 participants, with accompanying type intervention
Accompanying the participants, we support them to achieve their goals in improving their lifestyle habits by making phone calls or sending e-mails.
Period of accompanying type intervention: three months
Means:
e-mails, News or information regarding health, diet or exercise, twice a week
phone calls, Asking about the activities and progress towards achieving the goals, once a week
Interventions/Control_2
30 participants, without accompanying type intervention
They receive only the standard service included in FonesVisuas service, which is the lifestyle improvement guidance provided by a health nurse.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Other than agreeing to informed consent, there is no specific requirement.
Key exclusion criteria
individuals who takes prescription medications for medical purposes
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Okuma |
Organization
NEC Corporation
Division name
Healthcare and Life Science Division, Lifestyle Support Department
Zip code
108-8556
Address
14-1, 4-chome, Shiba, Minato-ku, Tokyo
TEL
070-2611-6812
k-okuma@nec.com
Public contact
Name of contact person
| 1st name | Remmy |
| Middle name | |
| Last name | Takeuchi |
Organization
NEC Corporation
Division name
Healthcare and Life Science Division, Lifestyle Support Department
Zip code
108-8556
Address
14-1, 4-chome, Shiba, Minato-ku, Tokyo
TEL
070-4451-8030
Homepage URL
r-takeuchi@nec.com
Sponsor or person
Institute
NEC Corporation
Institute
Department
Personal name
Funding Source
Organization
NEC Corporation
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
NEC Ethical Review Committee for the Life Sciences
Address
7-1, 5-chome, Shiba, Minato-ku, Tokyo
Tel
03-3454-1111
rinri-shinsa@dmsig.jp.nec.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
| 2024 | Year | 06 | Month | 04 | 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
55
Results
Results:
- Any outstanding effect is seen with the accompanying type intervention, in terms of risk score comparison.
- On the other hand, we have verified qualitative effectivity for the accompany type of intervention.
- Overall, it can be said that there is a certain effect using FonesVisuas to improve the risk score.
Results date posted
| 2025 | Year | 04 | Month | 22 | Day |
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
| 2024 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062258
