UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045830
Receipt number R000052322
Scientific Title Effects of a dementia education program using audio-visual materials from the first-person perspective of a person with dementia on nursing students' attitudes toward people with dementia
Date of disclosure of the study information 2021/10/22
Last modified on 2022/08/30 11:31:07

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Basic information

Public title

Effects of a dementia education program using audio-visual materials from the first-person perspective of a person with dementia in nursing students

Acronym

Effects of a dementia education program using audio-visual materials from the first-person perspective of a person with dementia

Scientific Title

Effects of a dementia education program using audio-visual materials from the first-person perspective of a person with dementia on nursing students' attitudes toward people with dementia

Scientific Title:Acronym

Effects of a dementia education program using audio-visual materials from the first-person perspective of a person with dementia on nursing students' attitudes toward people with dementia

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify the effects of a dementia educational program using audio-visual materials from the first-person perspective of a person with dementia for nursing students on the attitude toward people with dementia and knowledge of dementia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The attitude measured by Attitude toward People with Dementia Scale after intervention program

Key secondary outcomes

1)Knowledge of dementia
2)Helping behavioral intention for people with dementia


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

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

The dementia educational program utilizing short films and videos with virtual reality (VR) technology will be delivered to nursing students in their classes. This program includes (1) short film about people with dementia and their families, (2) VR video that allows students to experience the perspective of a person with dementia, (3) discussions about responses and impressions after watching the short film and VR, and (4) lectures to learn about dementia. These lectures consist of 90-minutes, three times sessions.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Second-year nursing students from a university in Tokyo who wish to participate in this program

Key exclusion criteria

1) Those who have difficulty in reading Japanese and cannot understand the contents of the research explanatory document
2) Those under 18 years old
3) Those who are absent from the lecture on the day conducting this program

Target sample size

33


Research contact person

Name of lead principal investigator

1st name Ayumi
Middle name
Last name Igarashi

Organization

The University of Tokyo

Division name

Graduate School of Medicine

Zip code

113-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-3507

Email

aigarashi@m.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Haruno
Middle name
Last name Suzuki

Organization

The University of Tokyo

Division name

Graduate School of Medicine

Zip code

113-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-3508

Homepage URL


Email

haruno@m.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

MEXT

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The University of Tokyo, Clinical Research Review Board

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

2021 Year 10 Month 22 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

2021 Year 10 Month 20 Day

Date of IRB

2021 Year 10 Month 11 Day

Anticipated trial start date

2021 Year 10 Month 20 Day

Last follow-up date

2021 Year 11 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 10 Month 22 Day

Last modified on

2022 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052322