UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040247
Receipt No. R000045859
Scientific Title Miyagi Karoshi Prevention Study for Teachers
Date of disclosure of the study information 2020/04/27
Last modified on 2020/04/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Miyagi Karoshi Prevention Study for Teachers
Acronym Miyagi Karoshi Prevention Study for Teachers
Scientific Title Miyagi Karoshi Prevention Study for Teachers
Scientific Title:Acronym Miyagi Karoshi Prevention Study for Teachers
Region
Japan

Condition
Condition general school workers
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to exmine the hypothesis if intervention according to home blood pressure category is effective to reduce cardiovascular risk in school workers associated mith microalbuminuria
Basic objectives2 Others
Basic objectives -Others cross-sectional analysis to examine the relationship between work stress, work conditions, others and cardiovascular risks or albuminuria
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes frequency of microalbuminuria 1 year after intervention
Key secondary outcomes Urine albumin excretion 1 year after intervention

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Subjects with home blood pressures 135 mm Hg or over for sytolic or 85 mm Hg or over for diastolic recieve lifestyle guidance and will be encouraged to consult doctor.
Subjects with home blood pressures 125 to 134 mm Hg for sytolic and 80 to 84mm Hg for diastolic will receive lifestyle guidance.
Subjects with home blood pressures below 125 and 80 mm Hg receive lifestyle guidance according to their metabolic risks.
Interventions/Control_2
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
75 years-old >
Gender Male and Female
Key inclusion criteria workers with microalbuminuria
Key exclusion criteria workers with macroalbuminuria
female workers dring menstrual period
Target sample size 180

Research contact person
Name of lead principal investigator
1st name MASANORI
Middle name
Last name MUNAKATA
Organization Tohoku Rosai Hospital
Division name Research Center for lifestyle-related disease
Zip code 981-8563
Address 3-21, Dainohara 4, Aobaku, Sendai
TEL 022-275-1111
Email munakata@tohokuh.johas.go.jp

Public contact
Name of contact person
1st name MASANORI
Middle name
Last name MUNAKATA
Organization Tohoku Rosai Hospital
Division name Research Center for lifestyle-related disease
Zip code 981-8563
Address 3-21, Dainohara 4, Aobaku, Sendai
TEL 022-275-1111
Homepage URL
Email munakata@tohokuh.johas.go.jp

Sponsor
Institute Japan Organization of Occupational Health and Safety
Institute
Department

Funding Source
Organization Japan Organization of Occupational Health and Safety
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 Tohoku Rosai Hospital
Address 3-21, Dainohara 4, Aobaku, Sendai
Tel 022-275-1111
Email soumu.shomu1@tohokuh.johas.go.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
2020 Year 04 Month 27 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 151
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 No longer recruiting
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
2018 Year 08 Month 20 Day
Anticipated trial start date
2020 Year 10 Month 21 Day
Last follow-up date
2021 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 27 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045859

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.