UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030651 |
|---|---|
| Receipt number | 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 | 2022/05/19 17:23:31 |
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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
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
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
sk11169@jrchcn.ac.jp
Sponsor or person
Institute
Japanese Red Cross Academy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034991
