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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043404
Receipt No. R000049489
Scientific Title Japanese Digital Hospital Art and Delirium: A Randomized Clinical Trial
Date of disclosure of the study information 2021/02/22
Last modified on 2021/02/22

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Basic information
Public title Investigating the association between diurnal variation in hospital room pictures and delirium
(Intervention study)
Acronym Investigating the association between diurnal variation in hospital room pictures and delirium
(Intervention study)
Scientific Title Japanese Digital Hospital Art and Delirium: A Randomized Clinical Trial
Scientific Title:Acronym JDHARD-Study
Region
Japan

Condition
Condition Delirium
Classification by specialty
Medicine in general Neurology Psychosomatic Internal Medicine
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether the incidence of "delirium" and the rate of self-extraction of intravenous drips are affected in a group of patients who decorate their hospital rooms with pictures with diurnal variation, a group of patients who decorate their rooms with pictures without diurnal variation, and a group of patients who do not decorate their rooms with pictures.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of delirium
Key secondary outcomes Incidence of self-removal of peripheral venous catheter

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Display a picture with diurnal variation in the hospital room between the first and third day of hospitalization
Interventions/Control_2 Display a picture without diurnal variation in the hospital room between the first and third day of hospitalization
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
120 years-old >
Gender Male and Female
Key inclusion criteria The following inpatients (number of patients) at Toyota Regional Medical Center will be included.
(1) General Medicine patients admitted urgently to the acute care ward
2) 65 years old or older
3) Patients who have consented to participate in the study, or whose family members have consented when the patient's will cannot be confirmed due to dementia, etc., or when the patient is unable to understand the contents of the study by himself/herself.
Key exclusion criteria 1) Patients with impaired consciousness with a JCS of 2 digits or higher on admission
2) Patients who are unable to see pictures on their own at the time of admission (e.g., decreased vision, inability to move head and neck by themselves)
3) Patients whose consent is withdrawn by themselves or their family members during the course of the research
4) Patients who die or are transferred to another hospital during the course of the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Toshinori
Middle name
Last name Nishizawa
Organization Toyota Regional Medical Center
Division name Department of General Medicine
Zip code 471-0062
Address 3-30-1, Nishiyama-cho, Toyota city, Aichi
TEL 09076891117
Email nishizawa.toshinori@gmail.com

Public contact
Name of contact person
1st name Toshinori
Middle name
Last name Nishizawa
Organization Toyota Regional Medical Center
Division name Department of General Medicine
Zip code 471-0062
Address 3-30-1, Nishiyama-cho, Toyota city, Aichi
TEL 09076891117
Homepage URL
Email nishizawa.toshinori@gmail.com

Sponsor
Institute Toyota Regional Medical Center
Institute
Department

Funding Source
Organization Toyota Regional Medical Center
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 Toyota Regional Medical Center
Address 3-30-1, Nishiyama-cho, Toyota city, Aichi
Tel 0565-34-3000
Email soumu@toyotachiiki-mc.or.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 02 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 Open public recruiting
Date of protocol fixation
2021 Year 01 Month 01 Day
Date of IRB
2021 Year 01 Month 26 Day
Anticipated trial start date
2021 Year 02 Month 22 Day
Last follow-up date
2022 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
2021 Year 02 Month 22 Day
Last modified on
2021 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049489

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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