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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032146
Receipt No. R000033508
Scientific Title Enforcement and evalution of Perioperative Period Frailty a nursing lntervention Program for Elder Patients Undergoing Thoracic endovascular aortic repair
Date of disclosure of the study information 2018/04/10
Last modified on 2018/04/07

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Basic information
Public title Enforcement and evalution of Perioperative Period Frailty a nursing lntervention Program for Elder Patients Undergoing Thoracic endovascular aortic repair
Acronym Enforcement and evalution of Perioperative Period Frailty a nursing lntervention Program for Elder Patients Undergoing Thoracic endovascular aortic repair
Scientific Title Enforcement and evalution of Perioperative Period Frailty a nursing lntervention Program for Elder Patients Undergoing Thoracic endovascular aortic repair
Scientific Title:Acronym Enforcement and evalution of Perioperative Period Frailty a nursing lntervention Program for Elder Patients Undergoing Thoracic endovascular aortic repair
Region
Japan

Condition
Condition Aortic dissection and Aortic aneurysm
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Trial and evaluate nursing intervention program for perioperative flail of elderly patients undergoing thoracic endovascular aortic repair
Basic objectives2 Others
Basic objectives -Others Trial and evaluation of nursing intervention program
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient can leave your home
Key secondary outcomes Declining physical function
Declines in nutritional status
Decline in QOL
Delirium onset

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Implementation of nursing intervention program during the period from nursing outpatient to discharge
Interventions/Control_2
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japanese who underwent chest stent graft interpolation over 75 years of age
Stent graft should also include debranching TEVAR with bypass surgery combined with occluded blood vessel
Research cooperation was obtained
Key exclusion criteria Patients with cognitive impairment MMSE under24
Patients with severe aphasia and hearing impairment
Patients receiving open stent graft open stent graft surgery
Surgery in case of emergency
When doctor permission can not be obtained
When judging that doctors and nurses are inappropriate
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoko Takanashi
Organization St. Luke's International University
Division name Graduate School of Nursing Science
Zip code
Address 10-1 Akashi-cho Chuo-ku Tokyo
TEL 03-3543-6391
Email 16mn013@slcn.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Takanashi
Organization St. Luke's International University
Division name Graduate School of Nursing Science
Zip code
Address 10-1 Akashi-cho Chuo-ku Tokyo
TEL 03-3543-6391
Homepage URL
Email 16mn013@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

Funding Source
Organization no
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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2018 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 10 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
2018 Year 04 Month 07 Day
Last modified on
2018 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033508

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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