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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033368
Receipt No. R000037530
Official scientific title of the study 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 2018/07/11

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Basic information
Official scientific title of the study The effectiveness of program on prevention of recurrent stroke utilizing health behavioral therapy
Title of the study (Brief title) 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 Yuriko Yamada
Organization Fukuoka University Hospital
Division name Nursing department
Address 7-45-1Nanakuma ,Jounan-ku,Fukuoka City
TEL 092-801-1011
Email yuri3010@cis.fukuoka-u.ac.jp

Public contact
Name of contact person Yuriko Yamada
Organization Fukuoka University Hospital
Division name Nursing department
Address 7-45-1Nanakuma ,Jounan-ku,Fukuoka City
TEL 092-801-1011
Homepage URL
Email yuri3010@cis.fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Hospital
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 16 Day
Anticipated trial start date
2017 Year 06 Month 16 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 Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 11 Day
Last modified on
2018 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037530

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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