UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014712 |
|---|---|
| Receipt number | R000017100 |
| Scientific Title | Cognitive intervention through a training program for picture-book reading in community-dwelling older adult |
| Date of disclosure of the study information | 2014/07/30 |
| Last modified on | 2014/07/30 15:38:26 |
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Basic information
Public title
Cognitive intervention through a training program for picture-book reading in community-dwelling older adult
Acronym
Cognitive intervention through a training program for picture-book reading
Scientific Title
Cognitive intervention through a training program for picture-book reading in community-dwelling older adult
Scientific Title:Acronym
Cognitive intervention through a training program for picture-book reading
Region
| Japan |
Condition
Condition
community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effectiveness of a cognitive intervention through a training program for picture-book reading for community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Logical Memory subscale from Wechsler Memory Scale Revised
Key secondary outcomes
Subtests of Wechsler Adult Intelligence Scale-III, such as Digit Span Forward and Digit Span Backward; Trail Making Test Part A and Part B; Kana Pick-out Test; verbal fluency tests; Mini-Mental State Examination, and the Japanese version of the Montreal Cognitive Assessment
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
After randomly dividing the participants into two groups, the intervention group start the picture-book reading program(once per week). After the 12 week picture-book reading program has been completed, follow-up cognitive tests are conducted for the participants of each group.
Interventions/Control_2
The control group participate in lectures about health maintenance once a month.
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
(i) age 65 years and older; (ii) memory complaint
Key exclusion criteria
diagnosed dementia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Suzuki |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
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 | |
| Middle name | |
| Last name | Hiroyuki Suzuki |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3964-3241
Homepage URL
suzukihy@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor, and Welfare of 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
| 2014 | Year | 07 | Month | 30 | 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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 30 | Day |
Last modified on
| 2014 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017100
