UMIN-ICDS Clinical Trial

Public title

Reliability and Validity of the FG Nomura-Keio Interview Checklist for Estimating and Understanding Cognitive Functions Related to Financial Management in Elderly People

Acronym

Reliability and Validity of the FG Nomura-Keio Interview Checklist for Estimating and Understanding Cognitive Functions Related to Financial Management in Elderly People

Scientific Title

Reliability and Validity of the FG Nomura-Keio Interview Checklist for Estimating and Understanding Cognitive Functions Related to Financial Management in Elderly People

Scientific Title:Acronym

Reliability and Validity of the FG Nomura-Keio Interview Checklist for Estimating and Understanding Cognitive Functions Related to Financial Management in Elderly People

Region

Japan

Condition

Dementia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the cognitive function using the FG Nomura Keio Interview Checklist (*FG: Financial Gerontology) in healthy elderly subjects and elderly subjects with dementia through a general conversation held during transactions at a financial institution. We will also evaluate cognitive function using an existing cognitive function test battery, verify correlations with the results obtained from the FG Nomura-Keio Interview Checklist, etc., and assess the usefulness of the FG Nomura-Keio Interview Checklist.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Correlation between the FG Nomura-Keio Interview Checklist and neuropsychological assessment batteries

Key secondary outcomes

construct validity, inter-rater reliability, and internal consistency of the Checklist

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

For patients
(1)Out-patients at the study sites diagnosed as having cognitive problems presented by patients or family members, or diagnosed with Mild Cognitive Impairments or Dementia according to DSM-5 or ICD-10.
(2) 65 years old or older at the time of study consent.
(3) Decisionally not impaired judged by treating physician. If judged as decisionally impaired, patients' guardians should give consent.

For healthy volunteers
(1) Healthy volunteers who offered to participate to the study through our study website or their registered activity group.
(2) 65 years old or older at the time of study consent.

Key exclusion criteria

For patients
(1) Patients whose illness can exacerbate by interview or assessment of the study.
(2) Patients who have comorbidities that can interfere with taking cognitive tests; such as psychiatric symptoms or physical disabilities.
(3) Those who are considered to be ineligible by the PI or investigators.

For healthy volunteers
(1) Those who have comorbidities that can interfere with taking cognitive tests; such as psychiatric symptoms or physical disabilities.
(2) Those who are considered to be ineligible by the PI or investigators.

Target sample size

150

Name of lead principal investigator

1st name	Taishiro
Middle name
Last name	Kishimoto

Organization

Keio University School of Medicine

Division name

Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes

Zip code

106-0041

Address

3-1 Azabudai Hills Mori JP Tower 7F, Azabudai, Minato-ku, Tokyo

TEL

03-5786-0006

Email

tkishimoto@keio.jp

Name of contact person

1st name	Shotaro
Middle name
Last name	Kinoshita

Organization

Keio University School of Medicine

Division name

Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes

Zip code

106-0032

Address

3-1 Azabudai Hills Mori JP Tower 7F, Azabudai, Minato-ku, Tokyo

TEL

03-5786-0006

Homepage URL

Email

shotaro.kinoshita@keio.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Nomura Holdings, Inc.
Nomura Securities Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Clinical and Translational Research Center

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都）、東京歯科大学市川総合病院（千葉県）、つつじメンタルホスピタル（群馬県）、湘南慶育病院

Date of disclosure of the study information

2022

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

150

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2021

Year

12

Month

15

Day

Date of IRB

2022

Year

02

Month

03

Day

Anticipated trial start date

2022

Year

05

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

[Observation items and data collection methods]
For patients:
A) Collection of background information
Collect demographical/clinical characteristics from chart, ward nursing staff and treating physician.
-gender, age, diagnosis, diagnosis subtype, duration of illness, comorbidities
-Clinical Dementia Rating (CDR), results of neuropsychological assessment
B) Interview, video recording, and Interview checklist
Interview with study participants for 30 minutes will be performed, and will be video-recorded for consented participants. After interview is done, the researcher will evaluate the participants' conversation based on the interview checklist.
C) Rating of cognitive status using neuropsychological battery
-Mini-mental Scale Examination (MMSE)
-Instrumental Activities of Daily Living (IADL)
-Financial Competency Assessment Tool (FCAT)
-Japanese versions of the Executive Interview (J-EXIT25)
D) Other
If patients have a record of above tests in C) within 90 days of the interview, the result will be considered to be used for this study. Final decision will be made among the study team.

For healthy subjects:
After consenting to the study, a researcher will assess patients' history of psychiatric illness or cognitive problem. For cognitive status, MMSE will be used to rule out any participants under 27 points from healthy subject group.
A) Collection of background information
Collect demographical/clinical characteristics from chart, ward nursing staff and treating physician.
-gender, age, diagnosis, diagnosis subtype, history of illness
B) Interview, video recording, and Interview checklist
Same as for patients
C)Rating of cognitive status using neuropsychological battery
Same as for patients

Registered date

2022

Year

04

Month

05

Day

Last modified on

2024

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053693