UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042860
Receipt number R000048906
Scientific Title Cognitive training via conversation support to healthy older adults-2(2)
Date of disclosure of the study information 2020/12/27
Last modified on 2023/06/27 05:14:31

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Basic information

Public title

Cognitive training via conversation support to healthy older adults-2(2)

Acronym

Cognitive training via conversation support to healthy older adults-2(2)

Scientific Title

Cognitive training via conversation support to healthy older adults-2(2)

Scientific Title:Acronym

Cognitive training via conversation support to healthy older adults-2(2)

Region

Japan


Condition

Condition

Healthy older adults

Classification by specialty

Neurology Geriatrics Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study's purpose is to gather evidence on the mid-term effect of a group conversation intervention on cognition in healthy older adults through followup study for subjects of the UMIN trial ID UMIN000036599 once a year after intervention for three years.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitive function
-Montreal Cognitive Assessment (MOCA)
-Mini Mental State Examination (MMSE)
-WMS-R, Logical memory I,II
-Advanced Trail Making Test (ATMT)
-Digit span
-Digit symbol
-Verbal fluency

During pandemic
-TICS-J
-Verbal fluency

Evaluation
1, 2, 3 years after intervention

Key secondary outcomes

Questionnaires
-The WHO Quality of Life questionnaire 26
-The Japanese version of the Geriatric Depression Scale short form
-The Tokyo Metropolitan Institute of Gerontology-Index of Competence
-Social Support Scale
-Coimagination Scale

Evaluation
1, 2, 3 years after intervention


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention group participants receive weekly 30-minute intervention sessions, each followed by 30 minutes of explanation about intervention.

Interventions/Control_2

Control group participants are required to commute to the research facility once a week.

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

(1)>=65 years old
(2)MMSE>=24
(3)Can complete evaluations and interventions
(4)Agree to participate

Key exclusion criteria

(1)Having any neurological impairment known to affect the central nervous system
(2)Having any serious complicating disorder
(3)Having any history of serious head injury
(4)Having any disease or medication known to affect the central nervous system

Target sample size

65


Research contact person

Name of lead principal investigator

1st name Mihoko
Middle name
Last name Otake-Matsuura

Organization

RIKEN

Division name

Center for Advanced Intelligence Project

Zip code

103-0027

Address

Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan

TEL

0362252482

Email

mihoko.otake@riken.jp


Public contact

Name of contact person

1st name Mihoko
Middle name
Last name Otake-Matsuura

Organization

RIKEN

Division name

Center for Advanced Intelligence Project

Zip code

103-0027

Address

Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan

TEL

0362252482

Homepage URL


Email

mihoko.otake@riken.jp


Sponsor or person

Institute

The RIKEN Center for Advanced Intelligence Project

Institute

Department

Personal name



Funding Source

Organization

The RIKEN Center for Advanced Intelligence Project

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

RIKEN, Bio Safety and Ethics Section

Address

2-1, Hirosawa, Wako, Saitama, Japan

Tel

0484679293

Email

human@riken.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 12 Month 27 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

Completed

Date of protocol fixation

2020 Year 07 Month 31 Day

Date of IRB

2019 Year 04 Month 26 Day

Anticipated trial start date

2020 Year 12 Month 27 Day

Last follow-up date

2023 Year 03 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 12 Month 26 Day

Last modified on

2023 Year 06 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048906


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name