UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The strategy for delirium in elderly patients with cardiovascular diseases Appropriate nursing based on the clinical background
Title of the study (Brief title)	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	Ajiki Kazuko
Organization	kitasato Institute Hospital
Division name	Nursing Department
Address	5-9-1 Sirokane Minato Tokyo
TEL	03-3444-6161
Email	byoto5@Institute.kitasato-u.ac.jp

Public contact
Name of contact person	Kikuchi Junko
Organization	kitasato Institute Hospital
Division name	Nursing Department 5F
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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