UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and Validation of Intergenerational Program for Regional Community
Title of the study (Brief title)	Development and Validation of Intergenerational Program for Regional Community
Region	Japan

Condition
Condition	None
Classification by specialty	Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Plan and build an intergenerational program that meets a regional community needs, and validate its effect on children and older adults after its implementation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Short Warwick-Edinburgh Mental Well-being Scale Japanese-version Evaluation time: about 1 week before and immediately after the intervention
Key secondary outcomes	The contact frequency by the daily life with elderly or child, Inclusion of Other in the Self Scale, generativity scale Japanese-version

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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intergenerational exchange program (1 hour/time)
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	6 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elementary school children Elderly over 65 years of age
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	Kumiko Morita
Organization	Tokyo Medical and Dental University
Division name	Community Health Promotion Nursing
Address	1-5-45, yushima, bunkyo-ku, tokyo, Japan
TEL	+81-3-5803-5337
Email	morita.phn@tmd.ac.jp

Public contact
Name of contact person	Kumiko Morita
Organization	Tokyo Medical and Dental University
Division name	Community Health Promotion Nursing
Address	1-5-45, yushima, bunkyo-ku, tokyo, Japan
TEL	+81-3-5803-5337
Homepage URL
Email	morita.phn@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University Community Health Promotion Nursing
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 12 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 18 Day
Anticipated trial start date	2015 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 18 Day
Last modified on	2016 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022315