UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010439 |
|---|---|
| Receipt number | R000012206 |
| Scientific Title | 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 23:44:47 |
* 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
Observation study of change by intergenerational program participation with the preschooler for the older adult who go to a day care centre
Acronym
Observation study of change by older adult's intergenerational program participation
Scientific Title
Observation study of change by intergenerational program participation with the preschooler for the older adult who go to a day care centre
Scientific Title:Acronym
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
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
| 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
| 1st name | |
| Middle name | |
| Last name | Kumiko Morita |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Health Care Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Health Care Sciences
Zip code
Address
TEL
Homepage URL
morita.phn@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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)
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
| 2013 | Year | 04 | Month | 07 | 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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012206
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
