UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033526 |
|---|---|
| Receipt number | 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 13:00:15 |
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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
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
m.masuda@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Juntendo University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038228
