UMIN-CTR Clinical Trial

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
Email	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
Email	aiizuka@tmig.or.jp

Sponsor
Institute	Tokyo Metropolitan Institute of Gerontology Social participation and community health
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048012