UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033368 |
|---|---|
| Receipt number | R000037530 |
| Scientific Title | The effectiveness of program on prevention of recurrent stroke utilizing health behavioral therapy |
| Date of disclosure of the study information | 2018/07/13 |
| Last modified on | 2019/03/25 15:23:19 |
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Basic information
Public title
The effectiveness of program on prevention of recurrent stroke utilizing health behavioral therapy
Acronym
The effectiveness of program on prevention of recurrent stroke utilizing health behavioral therapy
Scientific Title
The effectiveness of program on prevention of recurrent stroke utilizing health behavioral therapy
Scientific Title:Acronym
The effectiveness of program on prevention of recurrent stroke utilizing health behavioral therapy
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to clarify the effect of the program for prevention of recurrence of stroke using health behavior theory program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stage of Behavior Change Stage Model
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Do stroke recurrence prevention program using health behavior theory
Interventions/Control_2
Provide normal stroke prevention instruction
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clarity of consciousness
No higher brain dysfunction
Key exclusion criteria
Those who did not agree
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuriko |
| Middle name | |
| Last name | Yamada |
Organization
Fukuoka University Hospital
Division name
Nursing department
Zip code
8140180
Address
7-45-1Nanakuma ,Jounan-ku,Fukuoka City
TEL
092-801-1011
yuri3010@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Yamada |
Organization
Fukuoka University Hospital
Division name
Nursing department
Zip code
814-0180
Address
7-45-1Nanakuma ,Jounan-ku,Fukuoka City
TEL
092-801-1011
Homepage URL
yuri3010@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University 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
Fukuoka University Hospital Clinical Research Assist Center
Address
7-chome 7-chome 7-chome, Jonan-ku, Fukuoka-shi, Fukuoka Prefecture
Tel
092-801-1011
rinshou@adm.fukuoka-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 13 | 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
33
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 | 06 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037530
