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Reliability and validity of a smartphone application for screening dementia using verbal fluency

Status Approved

First Submitted Date

2020/10/25
Registered Date

2020/11/03
Last Updated Date

2020/09/20

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005561
Unique Protocol ID	B-1706-401-303
Public/Brief Title	Reliability and validity of a smartphone application for screening dementia using verbal fluency
Scientific Title	Reliability and validity of a smartphone application for screening dementia using verbal fluency
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	B-1706-401-303
Approval Date	2017-03-24
Institutional Review Board Name	Seoul National University Bundang Hospital Institutional Review Board
Institutional Review Board Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Institutional Review Board Telephone	031-787-8801
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Ki Woong Kim
Title	Professor
Telephone	+82-31-787-7432
Affiliation	Seoul National University Bundang Hospital
Address	Psychiatry department, Seoul National University Bundang Hospital
Contact Person for Public Queries
Name	Ki Woong Kim
Title	Professor
Telephone	+82-31-787-7432
Affiliation	Seoul National University Bundang Hospital
Address	Psychiatry department, Seoul National University Bundang Hospital
Contact Person for Updating Information
Name	Ki Woong Kim
Title	Professor
Telephone	+82-31-787-7432
Affiliation	Seoul National University Bundang Hospital
Address	Psychiatry department, Seoul National University Bundang Hospital

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Active, not recruiting
Date of First Enrollment	2017-05-29 Actual
Target Number of Participant	200
Primary Completion Date	2019-06-27 , Actual
Study Completion Date	2021-03-24 , Anticipated
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2017-05-29 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID	A092077

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	There is an increasing need for screening tests that can accurately detect dementia in its earlier stage. Using the categorical verbal fluency test(CVFT), we developed and posted an Android app named as ‘Traffic Light for Dementia’(TLiDe) which guides people to self-administer the CVFT. This study aimed to examine the reliability and validity of the automatically administered CVFT (tCVFT) using TLiDe and to compare the diagnostic accuracy for dementia of tCVFT with those of conventionally administered CVFT (cCVFT) and MMSE. This study found that categorical verbal fluency test score using mobile application showed a good degree of internal consistency and moderate test-retest reliability. The patient group showed the lower categorical verbal fluency test score than the control group. The categorical verbal fluency test score using mobile application was significantly correlated with those of the conventionally administered as well as score of Mini-Mental State Examination. The diagnostic accuracy, sensitivity and specificity for categorical verbal fluency test score using mobile application were found to be acceptable as a screening test for early dementia. In conclusion, categorical verbal fluency test based mobile application is reliable and valid screening tool in diagnosing early dementia.

Study Summary Information

Lay Summary

There is an increasing need for screening tests that can accurately detect dementia in its earlier stage. Using the categorical verbal fluency test(CVFT), we developed and posted an Android app named as ‘Traffic Light for Dementia’(TLiDe) which guides people to self-administer the CVFT. This study aimed to examine the reliability and validity of the automatically administered CVFT (tCVFT) using TLiDe and to compare the diagnostic accuracy for dementia of tCVFT with those of conventionally administered CVFT (cCVFT) and MMSE.
This study found that categorical verbal fluency test score using mobile application showed a good degree of internal consistency and moderate test-retest reliability. The patient group showed the lower categorical verbal fluency test score than the control group. The categorical verbal fluency test score using mobile application was significantly correlated with those of the conventionally administered as well as score of Mini-Mental State Examination. The diagnostic accuracy, sensitivity and specificity for categorical verbal fluency test score using mobile application were found to be acceptable as a screening test for early dementia. 
In conclusion, categorical verbal fluency test based mobile application is reliable and valid screening tool in diagnosing early dementia.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Cross-sectional
Target Number of Participant	200
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Normal control group
Cohort/ Group 1	Cohort/Group Description Cognitively normal controls from the participants of the Korean Longitudinal Study on Cognitive Aging and Dementia
Cohort/ Group 2	Cohort/Group Label Early dementia group
Cohort/ Group 2	Cohort/Group Description Dementia patients with the Clinical Dementia Rating (CDR) of 0.5 or 1 from the visitors to the Dementia Clinic of Seoul National University Bundang Hospital
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Community-dwelling and aged 60 years or older, and had adequate vision and hearing, although many wore glasses, and some required a hearing aid. We excluded the subjects who had major psychiatric disorders, neurologic disorder and serious medical disorders that could affect their cognitive function.
Sampling Method	100 dementia patients with the Clinical Dementia Rating (CDR) of 0.5 or 1 from the visitors to the Dementia Clinic of Seoul National University Bundang Hospital and 100 sex-matched cognitively normal controls from the participants of the Korean Longitudinal Study on Cognitive Aging and Dementia (KLOSCAD).
Condition(s)/Problem(s)	* (F00-F99)Mental and behavioural disorders (F03)Unspecified dementia Dementia
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 60Year~No Limit
	Description 100 dementia patients with the Clinical Dementia Rating (CDR) of 0.5 or 1 from the visitors to the Dementia Clinic of Seoul National University Bundang Hospital and 100 sex-matched cognitively normal controls from the participants of the Korean Longitudinal Study on Cognitive Aging and Dementia (KLOSCAD).
Exclusion Criteria	We excluded the subjects who had major psychiatric disorders, neurologic disorder, delrium, mental disturbance and serious medical disorders that could affect their cognitive function.
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Diagnostic accuracy
Timepoint	At the time screening tools were applied
Secondary Outcome(s) 1
Outcome	Reliability, Validity
Timepoint	At the time screening tools were applied

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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