UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042123
Receipt number R000048076
Scientific Title Investigation of effective methods for using cognitive training app in adults: An open-label, randomized, parallel-group study
Date of disclosure of the study information 2020/10/15
Last modified on 2023/10/17 09:38:24

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Basic information

Public title

Investigation of effective methods for using brain training app in healthy adults.

Acronym

Investigation of effective methods for using brain training app in healthy adults.

Scientific Title

Investigation of effective methods for using cognitive training app in adults: An open-label, randomized, parallel-group study

Scientific Title:Acronym

Investigation of effective methods for using cognitive training app in adults: An open-label, randomized, parallel-group study

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our aim is to investigate the effective methods for using brain training app which is implemented the speed training.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Intelligence test
2) Attention test
3) Frontal lobe function test
4) Memory test

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Other

Interventions/Control_1

Playing a brain training app using a tablet device(15 min per day, 2 days per week throughout the 6 weeks)

Interventions/Control_2

Playing a brain training app using a smartphone(15 min per day, 2 days per week throughout the 6 weeks)



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

90 years-old >

Gender

Male and Female

Key inclusion criteria

The healthy elderly

Key exclusion criteria

1) Person without medical history of the cerebral nerve disease.
2) Person without medical history of the mental disorder.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Mika
Middle name
Last name Otsuki

Organization

Hokkaido University

Division name

Faculty of Health Sciences

Zip code

060-0812

Address

N-12, W-5, Kita-Ku, Sapporo, Hokkaido

TEL

011-706-3376

Email

lasteroideb612@pop.med.hokudai.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Takakura

Organization

Hokkaido University

Division name

Faculty of Health Sciences, Department of Emergent Neurocognition

Zip code

0600812

Address

N-12, W-5, Kita-Ku, Sapporo, Hokkaido

TEL

011-706-3719

Homepage URL


Email

takakura@hs.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of health sciences ,Hokkaido University

Address

N-12, W-5, Kita-Ku, Sapporo, Hokkaido

Tel

0117063316

Email

shomu@hs.hokudai.ac.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 15 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

44

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Because the paper with the final results is currently under peer review.

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

2020 Year 11 Month 01 Day

Date of IRB

2020 Year 10 Month 29 Day

Anticipated trial start date

2020 Year 11 Month 01 Day

Last follow-up date

2022 Year 05 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 14 Day

Last modified on

2023 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048076


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name