UMIN-CTR Clinical Trial

Basic information
Public title	Pilot Trial against High-risk Individuals to support their visits to the attending physicians: A Occupational physicians or nurse-led, Workplace-based Prevention Program of Lifestyle-related Disease
Acronym	Pilot Trial of using Contact Notebook between Occupational physicians and Clinic physicians.
Scientific Title	Pilot Trial against High-risk Individuals to support their visits to the attending physicians: A Occupational physicians or nurse-led, Workplace-based Prevention Program of Lifestyle-related Disease
Scientific Title:Acronym	Pilot Trial of using Contact Notebook between Occupational physicians and Clinic physicians.
Region	Japan

Condition
Condition	Hypertension, diabetes mellitus, and/or dyslipidemia
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether intensive health support using Contact Notebook between occupational physicians and clinic physicians in the workplace will encourage workers to visit clinics and to enhance the effect of treatment or the health literacy in high-risk individuals without clinical visits.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Continued clinic visits
Key secondary outcomes	1.Results of health checkups associated with lifestyle-related disease 2.Results of health literacy and QOL associated questionnaires

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Heath guidance using Contact Notebook to encourage continued clinical visits
Interventions/Control_2	Conventional health guidance using normal medical referral letter
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	18 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Participating in General Health Checkups held as the mass screening, according to the Industrial Safety and Health Law 2. Meeting at least one of the following criteria: - systolic blood pressure >= 160 mmHg and dyastolic blood pressure >= 100 mmHg - Hemoglobin A1c (NGSP) >= 7.0% (if hemoglobin A1c levels are missing, fasting glucose levels >= 130mg/dl; if fasting glucose levels are also missing, casual glucose levels >= 180 mg/dl) - low-density lipoprotein cholesterol levels >= 200 mg/dl in males 3. Without clinical visits for hypertension, diabetes mellitus, and/or dyslipidemia
Key exclusion criteria	Referring to a clinic located inside the same company of occupational physicians or nurses.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuhito Middle name Last name Kazuhito Yokoyama
Organization	Juntendo University
Division name	Graduate School of Medicine, Department of Epidemiology and Environmental Health
Zip code	1138421
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-5802-1047
Email	kyokoya@juntendo.ac.jp

Public contact
Name of contact person	1st name Go Middle name Last name Go Muto
Organization	Juntendo University
Division name	Graduate School of Medicine, Department of Epidemiology and Environmental Health
Zip code	1138421
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-5802-1047
Homepage URL
Email	g-muto@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

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

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

IRB Contact (For public release)
Organization	Juntendo
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
Tel	03-5689-0726
Email	rinri@juntendo.ac.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	2016 Year 03 Month 23 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
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	2016 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date	2016 Year 03 Month 24 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 23 Day
Last modified on	2019 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024880