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

* 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-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 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


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

Value
https://center6.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