UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052215 |
|---|---|
| Receipt number | R000059270 |
| Scientific Title | Observational study on measuring communication skills |
| Date of disclosure of the study information | 2024/08/17 |
| Last modified on | 2024/04/01 18:19:31 |
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Basic information
Public title
Observational study on measuring communication skills
Acronym
Observational study on measuring communication skills
Scientific Title
Observational study on measuring communication skills
Scientific Title:Acronym
Observational study on measuring communication skills
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess age- and gender-related differences in communication skills in healthy males and females aged 20 years or over and less than 80 and to determine the correlation between evaluation items.
Basic objectives2
Others
Basic objectives -Others
Observational study on measuring communication skills
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Communication evaluation
Key secondary outcomes
Cognitive function test, Other questionnaire
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese males and females who are aged 20 years or over and less than 80 years at the time of written informed consent.
2.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Key exclusion criteria
1.Subjects diagnosed with dementia-related disease by a physician or through health checkups, etc. or subjects with suspected dementia.
2.Subjects receiving medication or outpatient treatment for a serious disease.
3.Subjects receiving exercise or diet therapy under the supervision of a physician.
4.Subjects with current or previous history of drug dependence or alcohol dependence.
5.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder.
6.Night or shift workers with irregular life patterns.
7.Subjects whose eating, sleeping, and other habits are extremely irregular.
8.Subjects who are having a very unbalanced diet.
9.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases.
10.Subjects who are unable to stop using, throughout the study period, products that may impact brain function (working memory), such as foods for specified health uses, foods with functional claims, health foods (including supplements), drugs, and quasi-drugs (ingredient: theanine, caffeine, polyphenol, soybean lecithin, DHA/EPA, taurine, ginkgo leaf, etc.).
11.Subjects who are participating in other clinical trials at the time of obtaining consent, and who plan to participate in other clinical trials within 4 weeks from the end of the study to the start of the main study of the study, or during the study.
12.Women who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
13.Subjects who have difficulty complying with recording of each survey form.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
Miyake Clinic Institutional Review Board
Address
4-2-17 Komagome, Toshima-ku, Tokyo 170-0003 Japan
Tel
03-6903-7211
jim@medipharma.co.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
| 2024 | Year | 08 | Month | 17 | 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
130
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 | 08 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 13 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 30 | Day |
Other
Other related information
(Supplemental observational study)
To assess age- and gender-related differences in communication skills in healthy males and females aged 20 years or over and less than 80 and to determine the correlation between evaluation items.
(Exclusion criteria continued)
14.Subjects whose various test results at screening indicate their ineligibility to participate in the study.
15.Other subjects who are considered ineligible for participation in the study by the investigator.
(Supplemental target sample size)
Sample size: 130 subjects (target number of subjects completing the study: 120)
Management information
Registered date
| 2023 | Year | 09 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059270
