UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025207 |
|---|---|
| Receipt number | 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 11:25:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kikurinn-cn@circus.ocn.ne.jp
Sponsor or person
Institute
kitasato Institute Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028769
