UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Enforcement and evalution of Perioperative Period Frailty a nursing lntervention Program for Elder Patients Undergoing Thoracic endovascular aortic repair
Title of the study (Brief title)	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	Naoko Takanashi
Organization	St. Luke's International University
Division name	Graduate School of Nursing Science
Address	10-1 Akashi-cho Chuo-ku Tokyo
TEL	03-3543-6391
Email	16mn013@slcn.ac.jp

Public contact
Name of contact person	Naoko Takanashi
Organization	St. Luke's International University
Division name	Graduate School of Nursing Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 31 Day
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

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