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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017561
Receipt No. R000020325
Scientific Title Randomized clinical trial to evaluate effect of occupational health support on work ability using instruction paper format issued by attending physician.
Date of disclosure of the study information 2015/05/15
Last modified on 2017/05/15

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Basic information
Public title Randomized clinical trial to evaluate effect of occupational health support on work ability using instruction paper format issued by attending physician.
Acronym REWARD-trial(RElationship With medicAl caRe anD workplace)
Scientific Title Randomized clinical trial to evaluate effect of occupational health support on work ability using instruction paper format issued by attending physician.
Scientific Title:Acronym REWARD-trial(RElationship With medicAl caRe anD workplace)
Region
Japan

Condition
Condition Rheumatoid arthritis or Diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism Clinical immunology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluates effectiveness of occupational health instruction format issued by attending physician to working patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Frequency of measures regarding health for working patients at workplace.
Key secondary outcomes *Working environment
*Employment status
*Presenteeism
*company correspondence

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 occupatinal health instructon format issued group
Interventions/Control_2 general practice group
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients who are working with payment
(2) Patients of rheumatoid arthritis or diabetes mellitus
(3) patients who gives informed consent by a document and agree to participate this study.
(4) For diabetes mellitus patients, patients who are with one of the following condition.
a) dysautonomia
b) history of hypoglycemic symptom
c) HbA1c>= 8.0% at the time of registration.
(5) For rheumatoid arthritis patients, whose HAQ score is higher than 0.5 at the time of registration.
Key exclusion criteria (1) brain (stroke, etc.), heart (myocardial infarction, etc.), kidney (chronic renal failure, etc.), a malignancy, such as severe complications patients.
(2) patients research doctor has determined to be inappropriate as a subject
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Fujino
Organization University of Occupational and Enviromental Health
Division name Department of Preventive Medicine and Community Health
Zip code
Address 1-1, Iseigaoka, Yahatanishiku, Kitakyushu, 807-8555, Japan
TEL 093-691-7244
Email zenq@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuhiko Kubo
Organization University of Occupational and Enviromental Health
Division name Department of Preventive Medicine and Community Health
Zip code
Address 1-1, Iseigaoka, Yahatanishiku, Kitakyushu, 807-8555, Japan
TEL 093-691-7244
Homepage URL
Email kubo@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Enviromental Health
Institute
Department

Funding Source
Organization Ministry of Health, Lobour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 産業医科大学第1内科(福岡県)
産業医科大学若松病院(福岡県)
福岡ゆたか中央病院(福岡県)
北九州総合病院(福岡県)
中間市立病院(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 15 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
Significant intervention effect was not observed.
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
2015 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 11 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 14 Day
Last modified on
2017 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020325

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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