UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized clinical trial to evaluate effect of occupational health support on work ability using instruction paper format issued by attending physician.
Title of the study (Brief title)	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	Yoshihisa Fujino
Organization	University of Occupational and Enviromental Health
Division name	Department of Preventive Medicine and Community Health
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	Tatsuhiko Kubo
Organization	University of Occupational and Enviromental Health
Division name	Department of Preventive Medicine and Community Health
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Significant intervention effect was not observed.
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/icdr_e/ctr_view.cgi?recptno=R000020325