UMIN-CTR Clinical Trial

Basic information
Public title	Effects of an educational program for getting the behavior of home blood pressure measurement in stroke patients : evaluation by a Randomized-controlled Trial
Acronym	Effects of an educational program for getting the behavior of home blood pressure measurement in stroke patients
Scientific Title	Effects of an educational program for getting the behavior of home blood pressure measurement in stroke patients : evaluation by a Randomized-controlled Trial
Scientific Title:Acronym	Effects of an educational program for getting the behavior of home blood pressure measurement in stroke patients
Region	Japan

Condition
Condition	stroke
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of educational program for getting a behavair of home blood pressure measurement in stroke patients by a Randomized-Controlled Trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of home blood pressure measurement(12 month passage)
Key secondary outcomes	The rate of home blood pressure measurement(1 month passage,3 month passage,7 month passage),the rate of stroke recurrent,the rate of death,weight,BMI,blood pressure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Continuous support in 6 months by nurse Once of face-to-face session 4 times of telephone supports To give a textbook and a self-management handbook To rent a sphygmomanometer
Interventions/Control_2	Standard treatment To give a textbook and a self-management handbook To rent a sphygmomanometer
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	55 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Stroke patient Patient of modified Rankin Scale ; 0-3 Plan of discharged home
Key exclusion criteria	A severely handicappped Patient of modified Rankin Scale : 4-5 Patient of dementia Patient of terminal
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Kishita
Organization	Japanese Red Cross Hiroshima College of Nursing
Division name	Gerontological Nursing
Zip code	7380052
Address	1-2 Ajinadai-Higashi Hatsukaichi-shi Hiroshima
TEL	0829-20-2800
Email	sk11169@jrchcn.ac.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Kishita
Organization	Japanese Red Cross Hiroshima College of Nursing
Division name	Gerontological Nursing
Zip code	7380052
Address	1-2 Ajinadai-Higashi Hatsukaichi-shi Hiroshima
TEL	0829-20-2800
Homepage URL
Email	sk11169@jrchcn.ac.jp

Sponsor
Institute	Japanese Red Cross Academy
Institute
Department

Funding Source
Organization	The present study was supported by JSPS KAKENHI Grant Number JP 18K17543
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Japan Red Cross Hiroshima College of Nursing
Address	1-2,Ajinadai-Higashi,Hatsukaichi,Hiroshima
Tel	0829-20-2874
Email	s16d1010@jrchcn.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 01 Month 04 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
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 12 Month 01 Day
Date of IRB	2017 Year 10 Month 27 Day
Anticipated trial start date	2018 Year 01 Month 04 Day
Last follow-up date	2020 Year 08 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	2017 Year 12 Month 31 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034991