UMIN-CTR Clinical Trial

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

Hypertension, diabetes mellitus, and/or dyslipidemia

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Juntendo University

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Juntendo

Address

Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan

Tel

03-5689-0726

Email

rinri@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

03

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

03

Month

23

Day

Last modified on

2019

Year

09

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024880