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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000237
Receipt No. R000000298
Scientific Title A large-scale study with collaboration of medical facilities and local administration in purpose of suicide prevention of middle-aged and elderly in the district of high-incidence of suicide
Date of disclosure of the study information 2005/09/14
Last modified on 2005/09/14

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Basic information
Public title A large-scale study with collaboration of medical facilities and local administration in purpose of suicide prevention of middle-aged and elderly in the district of high-incidence of suicide
Acronym Community intervention trial
Case-control study
Scientific Title A large-scale study with collaboration of medical facilities and local administration in purpose of suicide prevention of middle-aged and elderly in the district of high-incidence of suicide
Scientific Title:Acronym Community intervention trial
Case-control study
Region
Japan

Condition
Condition depression
suicide
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To investigate knowledge of and attitudes toward depression and suicide in a large community sample of residents and medical professionals among municipalities with high suicide rates in Japan
2) To investigate the effect of the comprehensive intervention trial of suicide prevention among municipalities with high suicide rates in Japan
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The knowledge of and attitudes toward suicide and depression
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 The Primary Suicide Prevention
The Secondary Suicide Prevention
The Tertiary Suicide PreventionThe Network of Suicide Prevention
Liaison Nurse
Screening Depression
Interventions/Control_2 Control
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
20 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria A baseline Questionnaire survey was carried out in 2002.
1) We selected four of six municipalities in the Kuji District, and three of seven municipalities in the Miyako District, which is located south of the Kuji Districts. A total of 7317 people, aged 20 to 79 years, were randomly selected from the Basic Resident Register of each of the seven municipalities. The survey was carried out from January through March in 2002.
2) We selected both all doctors and all nurses in Kuji district and Miyako district. The survey was carried out from May through June in 2002.

A Questionnaire survey after intervention was carried out in 2004.
1) We selected a total of 5453 people as subjects except the dead and moving people. The survey was carried out from May through July in 2004.
2) We selected both all doctors and all nurses in Kuji district and Miyako district. The survey was carried out from May through July in 2004.
Key exclusion criteria We excluded the people under 19 years old and over 80 years old in Questionnaire survey for residents.
Target sample size 7000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Sakai
Organization Iwate Medical University
Division name Department of Neuropsychiatry
Zip code
Address 19-1, Uchimaru, Iwate 020-8505, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Iwate Medical University
Division name Department of Neuropsychiatry
Zip code
Address 19-1, Uchimaru, Iwate 020-8505, Japan
TEL
Homepage URL
Email

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization The Grant-in-Aid for Psychiatric and Neurological Diseases and Mental Health (H14-008)from the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Hygiene and Preventive Medicine, Iwate Medical University
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

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 14 Day

Related information
URL releasing protocol http://www.ncnp-k.go.jp/ikiru-hp/report/sakai16.html
Publication of results Published

Result
URL related to results and publications http://www.ncnp-k.go.jp/ikiru-hp/report/sakai16.html
Number of participants that the trial has enrolled
Results
The knowledge of and attitude toward suicide and depression among the residents and medical professionals in Kuji District with high suicide rates improved after comprehensive community intervention in  purpose of suicide prevention.
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
2002 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2002 Year 03 Month 01 Day
Last follow-up date
2004 Year 07 Month 01 Day
Date of closure to data entry
2004 Year 09 Month 01 Day
Date trial data considered complete
2004 Year 09 Month 01 Day
Date analysis concluded
2005 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 14 Day
Last modified on
2005 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000298

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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