UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056676
Receipt number R000064742
Scientific Title Preliminary survey on usability of improved store displays and layout
Date of disclosure of the study information 2025/01/14
Last modified on 2025/01/08 16:42:57

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Basic information

Public title

Preliminary survey on usability of improved store displays and layout

Acronym

Preliminary survey on usability of improved store environment

Scientific Title

Preliminary survey on usability of improved store displays and layout

Scientific Title:Acronym

Preliminary survey on usability of improved store environment

Region

Japan


Condition

Condition

Mild cognitive impairment (MCI), Dementia, healthy older people

Classification by specialty

Neurology Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore the changes in behaviors of people with cognitive impairment when visiting a store with improved displays and layout

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

The time taken from entering to leaving the store when carrying out the task of shopping in a store, and a breakdown of that time (time required to find each designated product, time required to find the cash register, time required for payment).

Key secondary outcomes

Traces of movement in the store, correctness of shopping contents, behavioral errors and their frequencies, number and content of times when assistance was needed, number and content of times when there were difficulties or dangers
Evaluation using the Process Analysis of Daily Activities
Subjective evaluation of the store environment


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

The improvements will be made to the store displays and layout. Examples are shown below.
The floor map display will be made with easy-to-read font size and with pictures added.
The display of the location of the cash register and the place to queue will be made more comprehensible.
The display of the product category names will be made with easy-to-read color schemes and heights.

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patient group: Outpatients who have been diagnosed with MCI or mild dementia at our center and meet the following conditions.
1. They have the opportunity to do their own shopping on a regular basis
2. They can participate in the survey (which takes about 1.5 hours)
3. They can decide for themselves whether or not to cooperate with the survey
4. They are able to walk independently
2) Healthy older adult group: People who have no history of central nervous system disease and lead independent lives, and who meet the following conditions.
1. Mini-Mental State Examination Japanese version 28 points or more.
2. They have the opportunity to do their own shopping on a regular basis
3. They can participate in the survey (which takes about 1.5 hours)
4. They can decide for themselves whether or not to cooperate with the survey
5. They are able to walk independently

Key exclusion criteria

Nothing

Target sample size

6


Research contact person

Name of lead principal investigator

1st name Tami
Middle name
Last name Saito

Organization

National Center for Geriatrics and Gerontology

Division name

Department of Social Science

Zip code

474-8511

Address

7-430, Morioka-cho, Obu city, Aichi, 474-8511, Japan

TEL

0562-46-2311

Email

t-saito@ncgg.go.jp


Public contact

Name of contact person

1st name Sayaka
Middle name
Last name Okahashi

Organization

National Center for Geriatrics and Gerontology

Division name

Department of Social Science

Zip code

474-8511

Address

7-430, Morioka-cho, Obu city, Aichi, 474-8511, Japan

TEL

0562-46-2311

Homepage URL


Email

okahashi@ncgg.go.jp


Sponsor or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name



Funding Source

Organization

The Japan foundation for Aging and Health

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center for Geriatrics and Gerontology

Address

7-430 Morioka-cho, Obu City, Aichi

Tel

0562-46-2311

Email

yaday@ncgg.go.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

2025 Year 01 Month 14 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

Enrolling by invitation

Date of protocol fixation

2025 Year 01 Month 06 Day

Date of IRB

2025 Year 01 Month 06 Day

Anticipated trial start date

2025 Year 01 Month 14 Day

Last follow-up date

2025 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

2025 Year 01 Month 09 Day

Last modified on

2025 Year 01 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064742