UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000237 |
|---|---|
| Receipt number | 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 19:18:58 |
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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
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
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000298
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
