UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003026 |
|---|---|
| Receipt number | 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 19:48:24 |
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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
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
miyoshi@kokuho.or.jp
Sponsor or person
Institute
All-Japan Federation of National Health Insurance Organizations
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003669
