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Recruitment status Completed
Unique ID issued by UMIN UMIN000010439
Receipt No. R000012206
Official scientific title of the study Observation study of change by intergenerational program participation with the preschooler for the older adult who go to a day care centre
Date of disclosure of the study information 2013/04/07
Last modified on 2013/04/07

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Basic information
Official scientific title of the study Observation study of change by intergenerational program participation with the preschooler for the older adult who go to a day care centre
Title of the study (Brief title) Observation study of change by older adult's intergenerational program participation
Region
Japan

Condition
Condition None
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clearify what kind of change there is when elderly people participate in an intergenerational program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes facial expression
Key secondary outcomes conversation

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Older odults who participated in intergenerational programs and for whom video ovservation was available.
The participants were independent or could walk with walking assistance devices.
Key exclusion criteria serious dementia
Target sample size 30

Research contact person
Name of lead principal investigator Kumiko Morita
Organization Tokyo Medical and Dental University
Division name Graduate School of Health Care Sciences
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
Organization Tokyo Medical and Dental University
Division name Graduate School of Health Care Sciences
Address
TEL
Homepage URL
Email morita.phn@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
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
2013 Year 04 Month 07 Day

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 08 Month 26 Day
Anticipated trial start date
2011 Year 11 Month 15 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 Using time sampling, we conducted a structured observation study. We assessed the changes in eye contact, facial expression, engagement/behaviour, and conversation. The observation time was 5 minutes.

Management information
Registered date
2013 Year 04 Month 07 Day
Last modified on
2013 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012206


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