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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030104
Receipt No. R000034321
Scientific Title Delirium prevention trial for the patients admitted in acute care ward
Date of disclosure of the study information 2017/11/24
Last modified on 2019/07/17

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Basic information
Public title Delirium prevention trial for the patients admitted in acute care ward
Acronym Delirium prevention in acute care ward
Scientific Title Delirium prevention trial for the patients admitted in acute care ward
Scientific Title:Acronym Delirium prevention in acute care ward
Region
Japan

Condition
Condition delirium
Classification by specialty
Neurology Geriatrics Psychiatry
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare delirium incidence between 3 groups of patients; group of nursing intervention to prevent delirium, and 2 groups that take medicine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of delirium which is judged by Japanese version of Intensive Care Delirium Screening Checklist (ICDSC) score from Day 1 to Day 5 of admission.
Key secondary outcomes Nursing education effect on delirium in acure care ward.

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 3
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Nursing intervention to prevent delirium, from Day 1 to Day 5 of admission
Interventions/Control_2 Nursing intervention to prevent delirium, and taking 8 mg ramelteon at bedtime, from Day 1 to Day 5 of admission.
Interventions/Control_3 Nursing intervention to prevent delirium, and taking 15 mg suvorexant at bedtime, from Day 1 to Day 5 of admission.
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Delirium high risk patient
Key exclusion criteria Delirious patients on admission
Patients with contraindication of ramelteon or suvorexant
Patients who took ramelteon or suvorexant on admission
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eriko Sugawara
Organization Yokohama Brain and Spine Center
Division name Department of Neurology
Zip code
Address 1-2-1 Takigashira, Isogo-ku, Yokohama 235-0012, Japan
TEL 045-753-2500
Email er01-sugawara@city.yokohama.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eriko Sugawara
Organization Yokohama Brain and Spine Center
Division name Department of Neurology
Zip code
Address 1-2-1 Takigashira, Isogo-ku, Yokohama 235-0012, Japan
TEL 045-753-2500
Homepage URL
Email er01-sugawara@city.yokohama.jp

Sponsor
Institute Yokohama Brain and Spine Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜市立脳卒中・神経脊椎センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 24 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
2016 Year 06 Month 10 Day
Date of IRB
2016 Year 10 Month 31 Day
Anticipated trial start date
2016 Year 12 Month 05 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 24 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034321

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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