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Recruitment status Completed
Unique ID issued by UMIN UMIN000014712
Receipt No. 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

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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

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 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

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 (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
Email 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
Email suzukihy@tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
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 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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017100


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