UMIN-CTR Clinical Trial

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
Last 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
Email	yuri3010@cis.fukuoka-u.ac.jp

Public contact
1st 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
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)

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037530