UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017561
Receipt number 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 18:16:46

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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 or person

Institute

University of Occupational and Enviromental Health

Institute

Department

Personal name



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

Value
https://center6.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