UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043404 |
|---|---|
| Receipt number | 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 | 2024/02/25 11:18:28 |
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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
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
nishizawa.toshinori@gmail.com
Sponsor or person
Institute
Toyota Regional Medical Center
Institute
Department
Personal name
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
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
No URL
Publication of results
Unpublished
Result
URL related to results and publications
No URL
Number of participants that the trial has enrolled
20
Results
The project was unable to attract enough participants for statistical analysis due to difficulties in continuing the project midway through the project. The art-decorated group tended to have less delirium and self-extraction of IVs than the counties without art.
Results date posted
| 2024 | Year | 02 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(1) Normal art
(2)Digital art with intraday variation
(3) No art on display
Overall
n = 9
n = 3
n = 8
Delirium
2 (22 %)
0 (0 %)
4 (50 %)
Self-removal of IV
0 (0%)
0 (0%)
1 (12.5 %)
Age (average)
84.9
78.3
84.3
Gender, male
4 (44 %)
1 (33 %)
6 (75 %)
Dementia
6 (66 %)
0 (0%)
4 (50%)
Barthel Index (average)
48.3
93.3
45
Private rooms
3 (33 %)
1 (33 %)
4 (50 %)
Room has a window
6 (66 %)
2 (66 %)
6 (75 %)
Participant flow
Patients aged 65 years or older who were urgently admitted to the Department of General Medicine at Toyota Regional Medical Center between December 2020 and December 2021 were candidates for the study. On the first or second day of hospitalization, the person in charge explained the project to the candidates in their hospital rooms, and those who agreed to participate were selected for the intervention. Patients were divided into three groups: (1) a group displaying regular art, (2) a group displaying digital art with diurnal variation, and (3) a group not displaying art, and the person in charge randomly selected which group they would belong to. Patients with clear disturbance of consciousness or delirium by the time consent was obtained were excluded.
On the first or second day of hospitalization, patients who agreed to the project were randomly selected to belong to one of three groups: (1) a group with regular artwork, (2) a group with digital artwork that varied within a day, or (3) a group with no artwork.
After consent was obtained, patients who belonged to the group that displayed artwork in their hospital rooms were asked to spend their hospital stay with the artwork displayed on the walls of their rooms (intervention).
If, after obtaining consent, they became patients in the group that did not display pictures in their hospital rooms, they did not display art on the walls of their hospital rooms (non-intervention) and spent their hospitalization.
At the time consent was obtained, cognitive function was assessed.
The intervention was terminated 7 days after the study began or if the patient was moved from one acute care bed to another, was discharged from the hospital, or died.
During the intervention period, a physician other than the attending physician, who was not informed whether the pictures were on display, assessed delirium in the patient's room during the hours of 9:00 to 18:00. (The art was removed from the patient's room beforehand by the researcher so that the evaluator would not know whether the patient was an intervention or non-intervention patient.)
After the evaluation was completed, we analyzed whether the intervention of displaying the artwork in the patient's room reduced IV self-extraction and delirium, referring to the patient's medical records.
* Note that this project was terminated in August 2021 due to the transfer of the person in charge in April 2021, as the continuation of the project was judged to be difficult.
Adverse events
No
Outcome measures
The study examined whether displaying diurnal pictures in the patient's room would reduce "delirium" and self-extraction of intravenous drips.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
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
| 2024 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049489
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