UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040247 |
|---|---|
| Receipt number | R000045859 |
| Scientific Title | Miyagi Karoshi Prevention Study for Teachers |
| Date of disclosure of the study information | 2020/04/27 |
| Last modified on | 2024/10/29 10:25:38 |
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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
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
munakata@tohokuh.johas.go.jp
Sponsor or person
Institute
Japan Organization of Occupational Health and Safety
Institute
Department
Personal name
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
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
Intern Med. 2023 Apr 15;62(8):1123-1130.
Publication of results
Partially published
Result
URL related to results and publications
Intern Med. 2023 Apr 15;62(8):1123-1130.
Number of participants that the trial has enrolled
169
Results
One year later, logUAE was significantly and similarly decreased in both groups. Microalbuminuria was present in 31.2% for guided group and in 30.2% for non-guided group (n.s.).
Results date posted
| 2024 | Year | 05 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects were 169 members diagnosed as having microalbuminuria among 3868 Miygai prefectural school workers who agreed to participate in this study after signed informed consent
Participant flow
Ninety-one subjects among the 169 members agreed to receive the home-BP based health guidance. Guidance was given according to 5 days mean of home BP measurements.
Adverse events
Nothing particular
Outcome measures
Outcomes were urinary albumin excretion (UAE) and frequency of microalbuminuria in the next year.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
INTERNAL MEDICINE ADVANCE PUBLICATION
Management information
Registered date
| 2020 | Year | 04 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045859
