UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041926 |
|---|---|
| Receipt number | R000047848 |
| Scientific Title | Self Management Activity Program (SMAP) study to prevent dementia: a randomized control trial |
| Date of disclosure of the study information | 2020/09/29 |
| Last modified on | 2023/08/10 18:31:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Self Management Activity Program (SMAP) study to prevent dementia
Acronym
SMAP study to prevent dementia
Scientific Title
Self Management Activity Program (SMAP) study to prevent dementia: a randomized control trial
Scientific Title:Acronym
SMAP study to prevent dementia: a RCT
Region
| Japan |
Condition
Condition
Community dowelling older people
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the effects of self- management using the smartphone applications and walking program for facilitating physical, social and cognitive activity to prevent dementia in community dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
incident of dementia
Key secondary outcomes
cognitive function (global cognitive function, memory, attention, executive function, processing speed), physical function (muscle strength, walking speed), IADL, self-rated health, psychological status (depressive symptoms, loneliness, life satisfaction), life style ( physical and leisure activity, nutritional status, social network); neuroimaging(brain structure, brain activity); incident of disability and mortality.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group:
period: 30 months
self-management of daily various activity using smartphone
walking program (2 times per week)
Interventions/Control_2
control group:
period: 30 months
lecture about disease and health (3 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) completed baseline assessments
2) aged over 60 years
3) living in target area
4) wiliness to participate in the entirety of study
5) willingness and ability to provide written informed consent
Key exclusion criteria
1) have difficulty to participate intervention program such as sever disability or inhibited exercise some problem
2) inhibited exercises by doctor
3) diagnosed dementia
4) have been certified long term care insurance
5) unable to write/converse in Japanese
6) deficit of cognitive function assessment
7) lower MMSE score at baseline assessment: absolute score of < 23 for persons who have under 12 years of education, a score < 24 for persons who have 12 to 15 years of education, or a score < 26 for persons who have 16 years or more of education.
Target sample size
3498
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Geriatrics and Social Science
Zip code
474-8511
Address
7-430 Morioka-cho, Obu city, Aichi
TEL
0562-87-1285
shimada@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Harada |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
474-8511
Address
7-430 Morioka-cho, Obu city, Aichi
TEL
0562-44-5651(5684)
Homepage URL
harada-k@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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
National Center for Geriatrics and Gereontology; Research and Medical Division
Address
7-430 Morioka-cho Obu Aichi Japan
Tel
0562-46-2311
yaday@ncgg.go.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 | 09 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 08 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047848
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
