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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035405
Receipt No. R000040342
Scientific Title Self-Monitoring Activity Program: Effects of daily activity improvements on incident dementia in older adults
Date of disclosure of the study information 2018/12/30
Last modified on 2018/12/29

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Basic information
Public title Self-Monitoring Activity Program: Effects of daily activity improvements on incident dementia in older adults
Acronym SMAP: Effects of daily activity improvements on incident dementia
Scientific Title Self-Monitoring Activity Program: Effects of daily activity improvements on incident dementia in older adults
Scientific Title:Acronym SMAP: Effects of daily activity improvements on incident dementia
Region
Japan

Condition
Condition elderly adults
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we aimed to design a single-blind, randomized controlled trial to study dementia prevention effects of behavior change techniques, using an accelerometer and a newly developed daily activity booklet in the community-living older adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of dementia during 3 years
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 intervention: self-monitoring used an accelerometer
frequency: everyday
duration: 3 years
Interventions/Control_2 intervention: self-monitoring used an accelerometer and daily activity booklet
frequency: everyday
duration: 3 years
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 Aged 65 years and older
Japanese speaker
Adequate visual and auditory acuity to complete neuropsychological testing
Willingness to participate in the entirety of study
Willingness and ability to provide written informed consent
Key exclusion criteria Dementia diagnosis
Inability to use accelerometer or booklet due to cognitive decline
Any significant systemic illness or unstable medical condition
Sever disability
Target sample size 5390

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Shimada
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
Address 7-430 Morioka-cho, Obu, Aichi 474-8511, Japan
TEL 0562-44-5651
Email shimadan@cgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyujki Shimada
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
Address 7-430 Morioka-cho, Obu, Aichi 474-8511, Japan
TEL 0562-44-5651
Homepage URL
Email shimadan@cgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 12 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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 29 Day
Last modified on
2018 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040342

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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