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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025207
Receipt No. R000028769
Scientific Title The strategy for delirium in elderly patients with cardiovascular diseases Appropriate nursing based on the clinical background
Date of disclosure of the study information 2017/06/30
Last modified on 2016/12/06

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Basic information
Public title The strategy for delirium in elderly patients with cardiovascular diseases
Appropriate nursing based on the clinical background
Acronym The strategy for delirium in elderly patients with cardiovascular diseases
Scientific Title The strategy for delirium in elderly patients with cardiovascular diseases
Appropriate nursing based on the clinical background
Scientific Title:Acronym The strategy for delirium in elderly patients with cardiovascular diseases
Region
Japan

Condition
Condition Cardiology
Classification by specialty
Cardiology Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although we have many elderly patients with Cardiovascular diseases at our ward,we are not completely conscious about/aware of delirium in those patients.Patients with candiovascular disease must wear various medical devices,hence the risk of developing delirium is often high.However,there are some instances where proper nursing is not guen due to the lark of knowledge.We gave made a checklist for those at "highrisk of delirium",and intend to investigate the offetiveness of the checklist in preventing delirium.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Comparison before and after the number of cases of delirium
2. Comparison before and after the onset of delirium
3. Compare incidence before and after
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Positive in judgment by check sheet
Interventions/Control_2 Negative in judgment by check sheet
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

Not applicable
Gender Male and Female
Key inclusion criteria cardiovascular disease
Key exclusion criteria no
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ajiki Kazuko
Organization kitasato Institute Hospital
Division name Nursing Department
Zip code
Address 5-9-1 Sirokane Minato Tokyo
TEL 03-3444-6161
Email byoto5@Institute.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kikuchi Junko
Organization kitasato Institute Hospital
Division name Nursing Department 5F
Zip code
Address 5-9-1 Sirokane Minato Tokyo
TEL 03-3444-6161
Homepage URL
Email kikurinn-cn@circus.ocn.ne.jp

Sponsor
Institute kitasato Institute Hospital
Institute
Department

Funding Source
Organization kitasato Institute Hospital
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 30 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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 09 Day
Last modified on
2016 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028769

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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