UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061368 |
|---|---|
| Receipt number | R000070215 |
| Scientific Title | Randomized crossover study on the effect of different evaluation environments on subjective evaluation scores and elucidation of its factors |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/24 13:48:53 |
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Basic information
Public title
Study on the effect of different evaluation environments on subjective evaluation scores and elucidation of its factors
Acronym
Study on the effect of different evaluation environments on subjective evaluation scores and elucidation of its factors
Scientific Title
Randomized crossover study on the effect of different evaluation environments on subjective evaluation scores and elucidation of its factors
Scientific Title:Acronym
Randomized crossover study on the effect of different evaluation environments on subjective evaluation scores and elucidation of its factors
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of differences in evaluation environments (face-to-face vs. fully online) on data variability in subjective evaluations in clinical trials.
Basic objectives2
Others
Basic objectives -Others
To explore the criteria for participants suitable for online assessments by analyzing the impact of their psychological and behavioral characteristics and actual response conditions on measurement errors associated with the assessment environment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective mood and psychological state questionnaires
Key secondary outcomes
(1) Personality and psychological characteristics questionnaires
(2) literacy questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Online evaluation environment: Answering questionnaires in a non-supervised environment such as at home.
Interventions/Control_2
Face-to-face evaluation environment: Answering questionnaires under supervision at a designated venue.
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged 30 to 59 years at the time of providing informed consent.
(2) Individuals who feel a certain amount of stress in their daily lives.
(3) Individuals who have received a full explanation of the purpose and content of the study, have the capacity to provide consent, can understand the content well, and provide their own consent via electronic informed consent.
Key exclusion criteria
(1) Individuals receiving medical treatment, medication, or counseling by a physician for psychiatric disorders such as depression, anxiety, insomnia, or panic disorder.
(2) Individuals currently receiving medical treatment or medication by a physician for a serious chronic disease.
(3) Individuals with a serious medical history of cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine disease.
(4) Heavy drinkers.
(5) Individuals who do not have a communication/private room environment at home where they can quietly respond to questionnaires.
(6) Individuals with extremely irregular sleeping or eating habits.
(7) Individuals whose living environment, dietary habits, or exercise habits may change significantly during the study period.
(8) Women who are pregnant, may be pregnant, or intend to become pregnant during the study period.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
umin@macromill.com
Public contact
Name of contact person
| 1st name | Anna |
| Middle name | |
| Last name | Kadodani |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
Homepage URL
umin@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Macromill, 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
User Life Science Co.,Ltd.
Address
372-3,Niho,Iiduka-shi,Fukuoka,Japan
Tel
0948-82-3123
userlifescience@gmail.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
| 2026 | Year | 04 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 24 | Day |
Last modified on
| 2026 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070215
