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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003026
Receipt No. R000003669
Scientific Title Multicenter intervention study on the effects of health education program among outpatients under treatment of lifestyle diseases.
Date of disclosure of the study information 2010/01/13
Last modified on 2011/07/15

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Basic information
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
Condition Diabetes, Hyperpiesia, Hyperlipidemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes clinical indicators, drug cost
Key secondary outcomes Patient satisfaction, medical cost

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 Central registration

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute All-Japan Federation of National Health Insurance Organizations
Institute
Department

Funding Source
Organization All-Japan Federation of National Health Insurance Organizations
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Japan National health insurance Clinics and hospitals Association
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 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)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

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 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
Other related information

Management information
Registered date
2010 Year 01 Month 13 Day
Last modified on
2011 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003669

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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