UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035405 |
|---|---|
| Receipt number | 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 18:09:00 |
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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
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
shimadan@cgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040342
