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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033526
Receipt No. R000038228
Scientific Title Development of the ANSHIN support program for patients with unruputured intracranial aneurysms in a wait and see approach.
Date of disclosure of the study information 2018/07/27
Last modified on 2019/08/05

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Basic information
Public title Development of the ANSHIN support program for patients with unruputured intracranial aneurysms in a wait and see approach.
Acronym Development of the ANSHIN support program
Scientific Title Development of the ANSHIN support program for patients with unruputured intracranial aneurysms in a wait and see approach.
Scientific Title:Acronym Development of the ANSHIN support program
Region
Japan

Condition
Condition unruputured intracranial aneurysms
Classification by specialty
Vascular surgery Neurosurgery Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to develop o the ANSHIN support program for patients with unruptured intracranial anerysms in a wait and see approach.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes SF-36
Key secondary outcomes HADS, UUIS

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 e-learning, one or more
Interventions/Control_2 control
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with unruputured intracranial aneurysms in a wait and see approach, or patients familior to the operation of a personal computor or smartphone.
Key exclusion criteria Patients with decline in cognitive function, or patients with asymptomatic unruptured intracranial anerysms.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hidenori
Middle name
Last name Oishi
Organization Juntendo University
Division name School of Medicine
Zip code 113-8421
Address +81-3-3813-3111
TEL 03-3813-3111
Email ohishi@juntendo.ac.jp

Public contact
Name of contact person
1st name Mitsumi
Middle name
Last name Masuda
Organization Nagoya City University
Division name School of Nursing
Zip code 467-8601
Address +81-52-853-8063
TEL 052-853-8063
Homepage URL
Email m.masuda@med.nagoya-cu.ac.jp

Sponsor
Institute Juntendo University, School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University
Address School of Medicine
Tel 03-3813-3111
Email ohishi@juntendo.ac.jp

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 順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 27 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 37
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
2017 Year 09 Month 01 Day
Date of IRB
2017 Year 10 Month 17 Day
Anticipated trial start date
2017 Year 10 Month 17 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 26 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038228

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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