- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235127
The Catalonia Suicide Risk Code Epidemiology Study: an Epidemiological Study of Suicide Attempts in Catalonia, Spain (CSRC-Epi)
January 24, 2020 updated by: Jordi Alonso, Hospital del Mar Research Institute (IMIM)
The Catalonia Suicide Risk Code Epidemiology Study: a Two-Stage Exposure-Enriched Nested Case-Control Study of Suicide Attempts in Catalonia, Spain
Suicide attempts (SA) constitute a major public health issue worldwide.
Research suggests that 2.7% of adult people ever attempt suicide; among children and adolescents this is estimated to be 6.0%.
SA are related to subsequent suicide which represents an annual loss of 34.6 million years of life worldwide.
Suicide attempts are also related to persistent physical and mental health issues, psychiatric hospitalizations, impaired academic performance, unemployment, partner abuse victimization and perpetration, having children removed by social services, loneliness, relationship difficulties, impaired social functioning and low life satisfaction.
Despite this considerable societal impact, there is a lack of epidemiological research focussing on providing suicide attempt surveillance in the population, to inform public health action aimed at reducing risk for suicide attempts in the population, and to provide data-driven support for suicide risk assessment across healthcare settings.
To address this shortcoming, the investigators designed the Catalonia Suicide Risk Code Epidemiology study.
Using centralized Electronic Healthcare Record data from the entire public healthcare system of Catalonia, Spain, the CSRC-Epi study aims to estimate reliable suicide incidence rates, identify suicide attempt risk factors, and develop validated suicide attempt risk prediction tools.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
186000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The target population consists of the dynamic cohort of all Catalan residents during the 6-year period 2014-2019.
Description
Inclusion Criteria:
- Catalan residency during 2014-2019
- age 10 or more at end of observation period
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Catalan population
The target population consists of the dynamic cohort of all Catalan residents during the 6-year period 2014-2019.
Annual total population of Catalonia is between 7.5-7.6 million, with annual rates for immigration, emigration, birth and death being ~2.5%, ~1.9%, ~0.9%, and ~0.8%, respectively.
Based on these figures, we expect a maximum of ~9.1 million individuals with Catalan residency status on at least one point in time over the 2014-2019 period.
However, we expect SA in Catalonia to be extremely rare before the age of 10, in line with findings that self-injurious behaviour generally occurs as from the adolescent period.
We will therefore exclude cases and controls that have not reached age 10 by the end of the 2014-2019 period (i.e., ~10.9%), lowering the total expected target population to ~8.1 million.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of catalan residents with suicide attempt (incidence)
Time Frame: 2014-2019
|
Suicide attempt is a nonfatal, self-directed, potentially injurious behaviour with a non-zero degree of intent to die as a result of the behaviour, even if the behaviour does not result in injury
|
2014-2019
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Catalan residents committing suicide (incidence)
Time Frame: 2014-2019
|
Suicide is a fatal, self-directed, injurious behaviour with a non-zero degree of intent to die as a result of the behaviour
|
2014-2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
January 16, 2020
First Submitted That Met QC Criteria
January 16, 2020
First Posted (Actual)
January 21, 2020
Study Record Updates
Last Update Posted (Actual)
January 28, 2020
Last Update Submitted That Met QC Criteria
January 24, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSRC-EPI (2017/7431/I)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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