UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035509
Receipt number R000040414
Scientific Title Individual reactions to viewing preferred video representations in older people with dementia
Date of disclosure of the study information 2019/02/01
Last modified on 2023/06/01 21:22:49

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Individual reactions to viewing preferred video representations in older people
with dementia

Acronym

Individual reactions to viewing preferred video representations in older people
with dementia

Scientific Title

Individual reactions to viewing preferred video representations in older people
with dementia

Scientific Title:Acronym

Individual reactions to viewing preferred video representations in older people
with dementia

Region

Japan


Condition

Condition

dementia

Classification by specialty

Geriatrics Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to examine individual reactions to viewing preferred video in older people with dementia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Autonomic nervous activities compared before and after intervention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

single viewing video

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

older people with dementia and without any visual or hearing-imparement

Key exclusion criteria

people with visual or hearing-imparement

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Masae
Middle name
Last name Tsutsumi

Organization

Yamaguchi University

Division name

Graduate School of Medicine

Zip code

755-8505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

TEL

0836-22-2818

Email

tutumi@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Masae
Middle name
Last name Tsutsumi

Organization

Yamaguchi University

Division name

Graduate School of Medicine

Zip code

755-8505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

TEL

0836-22-2818

Homepage URL


Email

tutumi@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University

Institute

Department

Personal name



Funding Source

Organization

Yamaguchi University

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

Ethical Review Board of Nursing and Laboratory Science Graduate School of Medicine Yamaguchi University

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi

Tel

0836-22-2007

Email

me202@yamaguchi-u.ac.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

2019 Year 02 Month 01 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

24

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

2019 Year 01 Month 11 Day

Date of IRB

2019 Year 04 Month 24 Day

Anticipated trial start date

2019 Year 02 Month 06 Day

Last follow-up date

2022 Year 07 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 10 Day

Last modified on

2023 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040414


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name