UMIN-CTR Clinical Trial

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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