UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042071 |
|---|---|
| Receipt number | R000048012 |
| Scientific Title | Cognitive intervention through a training program for picture book reading in middle and old aged adults. |
| Date of disclosure of the study information | 2020/10/13 |
| Last modified on | 2022/05/11 13:18:27 |
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Basic information
Public title
Cognitive intervention through a training program for picture book reading in middle and old aged adults.
Acronym
Intervention study of picture book reading program
Scientific Title
Cognitive intervention through a training program for picture book reading in middle and old aged adults.
Scientific Title:Acronym
Intervention study of picture book reading program
Region
| Japan |
Condition
Condition
community-dwelling middle and old aged people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a cognitive intervention program for picture book reading on cognition, mental health and physical function in middle and old aged people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Memory(Logical MemoryI,II(Wechsler Memory Scale-Revised))
Key secondary outcomes
Cognitive test battery, Physical function, Mental health, Social variables, Instrumental Activities of Daily Living, Frequency of participation in group activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group attend a picture-book reading program held once a week, 120 minutes each time and total of 12 times in the community space.
Interventions/Control_2
Participants in the control group attend lectures on health maintenance once a month and a total of three times.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) ADL-independent (ii) cognitively healthy people (iii) People who sufficiently understand the purpose and content of the research, and who have the ability to agree informed consent.
Key exclusion criteria
(i) People with visual impairment and hearing loss that interfere their daily life (ii) Participants who have been already diagnosed dementia (iii) People who are found by medical doctors (co-researchers of this study) to be unable to participate in this program due to significant illness, physical dysfunction, dementia, and neuropsychological disorders etc.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Social participation and community health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3964-3241
suzukihy@tmig.or.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Iizuka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Social participation and community health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3964-3241
Homepage URL
aiizuka@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Social participation and community health
Institute
Department
Personal name
Funding Source
Organization
Local government in Japan
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute o Gerontology
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
Tel
03-3964-3241
naomi_hasegawa@tmghig.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
| 2020 | Year | 10 | Month | 13 | 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
Main results already published
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 10 | Day |
Last modified on
| 2022 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048012
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
