UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052091 |
|---|---|
| Receipt number | R000059369 |
| Scientific Title | Prospective observational study to evaluate the feasibility of the mobile app version of the Japanese Montreal Cognitive Assessment (MoCA-J) |
| Date of disclosure of the study information | 2023/09/04 |
| Last modified on | 2024/07/03 18:25:39 |
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Basic information
Public title
Prospective observational study to evaluate the feasibility of the mobile app version of the Japanese Montreal Cognitive Assessment (MoCA-J)
Acronym
Prospective observational study to evaluate the feasibility of the mobile app version of the Japanese Montreal Cognitive Assessment (MoCA-J)
Scientific Title
Prospective observational study to evaluate the feasibility of the mobile app version of the Japanese Montreal Cognitive Assessment (MoCA-J)
Scientific Title:Acronym
Prospective observational study to evaluate the feasibility of the mobile app version of the Japanese Montreal Cognitive Assessment (MoCA-J)
Region
| Japan |
Condition
Condition
Healthy volunteer, Patient with mild cognitive impairment, mild dementia, or moderate dementia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the feasibility of the mobile app version of MoCA-J by comparing its results with the standard MoCA-J.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of participants who successfully completed the mobile app version of MoCA-J.
Key secondary outcomes
The degree of agreement between scores and corresponding items of the mobile app version of MoCA-J and the standard MoCA-J
For both the app-first group and the standard test-first group, the degree of agreement between scores and corresponding items of the mobile app version of MoCA-J and the standard MoCA-J
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged between 20 and 90 at the time of consent.
2. Individuals who received a sufficient explanation about the study and gave their consent, either personally or through a family member.
Key exclusion criteria
1. Individuals who have undergone the MoCA-J within one month of the planned study participation date.
2. Those who are unable to operate a smartphone due to visual or hearing impairments, motor dysfunctions, or other disabilities.
3. Participants deemed unsuitable for the study's implementation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Reo |
| Middle name | |
| Last name | Hamaguchi |
Organization
LifeQuest Co., Ltd.
Division name
none
Zip code
107-0062
Address
6-6-21-9F, Minami-Aoyama, Minato-ku, Tokyo
TEL
03-6427-6474
hamaguchi@life-q.jp
Public contact
Name of contact person
| 1st name | Reo |
| Middle name | |
| Last name | Hamaguchi |
Organization
LifeQuest Co., Ltd.
Division name
none
Zip code
107-0062
Address
LifeQuest Co., Ltd.
TEL
03-6427-6474
Homepage URL
hamaguchi@life-q.jp
Sponsor or person
Institute
LifeQuest Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
LifeQuest Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ichigaya Himorogi Clinic
Nanko Kokoro no Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ichigaya Himorogi Clinic Ethics Committee
Address
3F, Ichigaya ASUKARA Building, 2-31-3 Ichigaya-Tamachi, Shinjuku-ku, Tokyo
Tel
03-5946-8584
kannari.junko@shintokukai.org
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
| 2023 | Year | 09 | Month | 04 | 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
| 2023 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The mobile app version of MoCA-J and the standard MoCA-J will be conducted in two groups: one that undergoes the standard test first followed by the app-based test, and another that starts with the app-based test followed by the standard test. Each test will be performed with an interval of at least one day within a two-week period.
The information to be collected is listed below:
Participant background (age, gender, highest level of education, height, weight, habits/preferences, current medical conditions under treatment)
Scores of the standard MoCA-J, including scores for each question
Input status for each question in the mobile app version of MoCA-J, overall score, scores for each question, and any occurrence/duration of malfunctions.
Management information
Registered date
| 2023 | Year | 09 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059369
