UMIN-CTR Clinical Trial

Public title

Multicenter intervention study on the effects of health education program among outpatients under treatment of lifestyle diseases.

Acronym

Health education program among outpatients under treatment of lifestyle diseases.

Scientific Title

Multicenter intervention study on the effects of health education program among outpatients under treatment of lifestyle diseases.

Scientific Title:Acronym

Health education program among outpatients under treatment of lifestyle diseases.

Region

Japan

Condition

Diabetes, Hyperpiesia, Hyperlipidemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the effects of health education programs within hospitals on lifestyle change, improvement of clinical indicators and health economic outcomes such as drug cost in patients under treatment of lifestyle diseases.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

clinical indicators, drug cost

Key secondary outcomes

Patient satisfaction, medical cost

Study type

Interventional

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

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Intensive counseling on lifestyle modifications, provided by face-to-face method every month for 6 months, and continued counseling (every 3 month for a year)

Interventions/Control_2

Health check every month for 6 months, and continued health check (every 3 month for a year)

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

30

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Patients holding National Health Insurance
2.Patients under drug therapy for either diabetes, hyperpiesia, or Hyperlipidemia
3.Patients meeting any one of the following criteria: blood pressure above 140/90 mmHg; LDL cholesterol above 140mg/dl; HbA1c above 6.5%

Key exclusion criteria

Patients meeting any one of the following criteria:
1)Blood pressure above 180/110 mmHg;
2)LDL cholesterol above 220mg/dl;
3)HbA1c above 8.0%;
4)Having been insulin-treated
5)Having difficulty to follow exercise instruction due to serious low back pain or knee (joint) pain;
6)Having prior myocardial infarction or stroke;
7)Having difficulty to obtain doctor's permission due to complication.

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	YOSHINORI TOMINAGA

Organization

KOHKA GENERAL HOSPITAL

Division name

General Affairs Department

Zip code

Address

3,39ROKUSHIN,MINAKUCHI-CHO,

TEL

0748-62-0234

Email

Name of contact person

1st name
Middle name
Last name

Organization

All-Japan Federation of National Health Insurance Organizations

Division name

Health Department

Zip code

Address

Zenkoku Choson kaikan Bidg.,11-35,Nagata-cho 1-chome, CHIYODA-KU,TOKYO

TEL

03-3581-6825

Homepage URL

Email

miyoshi@kokuho.or.jp

Institute

All-Japan Federation of National Health Insurance Organizations

Institute

Department

Personal name

Organization

All-Japan Federation of National Health Insurance Organizations

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Japan National health insurance Clinics and hospitals Association

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

市立大森病院（秋田県）、涌谷町町民医療福祉センター（宮城県）、南砥市民病院（富山県）、公立みつぎ総合病院（広島県）、国民健康保険坂下病院（岐阜県）、公立甲賀病院（滋賀県）、国民健康保険平戸市民病院（長崎県）、三豊総合病院（香川県）、国東市民病院（大分県）、杵築市立山香病院（大分県）

Date of disclosure of the study information

2010

Year

01

Month

13

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2008

Year

08

Month

07

Day

Date of IRB

Anticipated trial start date

2011

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

01

Month

13

Day

Last modified on

2011

Year

07

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003669