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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030651
Receipt No. R000034991
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
Date of disclosure of the study information 2018/01/04
Last modified on 2019/07/09

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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,blood examination result data(TC,TG,LDL-C,HDL-C,Cr,BUN,FBS,HbA1c)

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 Self funding
Organization
Division
Category of Funding Organization Self funding
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 Enrolling by invitation
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 10 Month 07 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
2019 Year 07 Month 09 Day


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

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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