UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026458 |
|---|---|
| Receipt number | R000030395 |
| Scientific Title | Development and effectiveness of intergenerational exchange program of elderly and elementary school students in urban area of China |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2018/10/01 11:46:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development and effectiveness of intergenerational exchange program of elderly and elementary school students in urban area of China
Acronym
Development and effectiveness of intergenerational exchange program of elderly and elementary school students in urban area of China
Scientific Title
Development and effectiveness of intergenerational exchange program of elderly and elementary school students in urban area of China
Scientific Title:Acronym
Development and effectiveness of intergenerational exchange program of elderly and elementary school students in urban area of China
Region
| Asia(except Japan) |
Condition
Condition
Health people
Elderly, Child
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is aimed to verify the effect of intergenerational exchange program of elderly and elementary school students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.semantic differential scale
2.inclusion of other in the self scale
3.the short Warwick-Edinburgh mental well-being scale
4.self-esteem scale
5.social anxiety scale for children
6.perspective taking
7.social skill scale
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention group (120): For six times of intervention , once 60 minutes, two months during a period of the intervention
Control group (120 subjects): to take ordinary school health course
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
| 9 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
4.5.6th grader of elementary school
Key exclusion criteria
NONE
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MORITA KUMIKO |
Organization
TOKYO MEDICAL AND DENTAL UNIVERSHITY
Division name
COMMUNITY HEALTH PROMOTION NURSING
Zip code
Address
1-5-45 YUSHIMA BUNKYO-KU TOKYO 113-8519
TEL
03-5803-5337
morita.phn@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | LYU XIAOWEI |
Organization
TOKYO MEDICAL AND DENTAL UNIVERSHITY
Division name
COMMUNITY HEALTH PROMOTION NURSING
Zip code
Address
1-5-45 YUSHIMA BUNKYO-KU TOKYO 113-8519
TEL
03-5803-5337
Homepage URL
ns140003@tmd.ac.jp
Sponsor or person
Institute
TOKYO MEDICAL AND DENTAL UNIVERSHITY
Institute
Department
Personal name
Funding Source
Organization
TOKYO MEDICAL AND DENTAL UNIVERSHITY
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 05 | Month | 31 | 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
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 08 | Day |
Last modified on
| 2018 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030395
