- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07750782
Environmental and Geographic Patterns of Occupational Injuries (WEATHER-WORK)
6 de agosto de 2026 atualizado por: Sergio Gabriel Susmallian
Environmental and Geographic Patterns of Occupational Injuries: A Population-Based Retrospective Study
This study will determine whether extreme ambient temperatures increase the incidence and severity of occupational injuries in Israel, and we request Helsinki Committee approval to conduct the analysis using de-identified National Insurance and historical meteorological data, with a waiver of informed consent.
The project will link the date, time, and geographic location of recognized occupational accidents with corresponding historical temperature and humidity measurements.
The study is retrospective, observational, and involves no direct contact with participants, no intervention, and no alteration of medical care or benefit eligibility.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
Occupational injuries represent an important source of preventable morbidity, permanent disability, loss of employment, and economic burden.
Rising temperatures and increasingly frequent heatwaves may impair concentration, coordination, judgment, reaction time, hydration, and physical endurance, particularly among workers in construction, agriculture, transportation, manufacturing, and other outdoor or physically demanding occupations.
However, the national relationship between ambient heat and work-related injury in Israel has not been adequately quantified.
Without reliable population-level evidence, employers, occupational-health authorities, and policymakers cannot identify temperature thresholds at which preventive measures should be intensified or determine which workers and industries are at greatest risk.
Tipo de estudo
Observacional
Inscrição (Real)
350000
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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-
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Rishon LeZiyyon, Israel, 7526557
- Israel National Insurance Institute
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra de Probabilidade
População do estudo
The study population will include adults aged 18 years or older with occupational injuries recognized by the National Insurance Institute between January 1, 2020, and December 31, 2024.
Eligible records will be selected from the national occupational-injury administrative database and assigned to one of seven predefined geographic-climatic regions according to the workplace or accident location.
Environmental exposure will be determined by linking each injury date, time, and location to the nearest representative meteorological monitoring station.
The study will include workplace, occupational-traffic, and commuting injuries meeting the prespecified eligibility criteria.
Descrição
Inclusion Criteria:
- Individuals aged 18 years or older with an occupational injury recognized by the National Insurance Institute.
- Occupational injury occurring between January 1, 2020, and December 31, 2024.
- Injury occurring at the workplace, during occupational travel, or while commuting to or from work.
- Valid injury date and geographic information sufficient to assign the accident to one of the seven predefined geographic-climatic regions and the nearest representative meteorological station.
- Meteorological measurements available for the injury period and eligible matched control periods.
For time-specific analyses, a valid recorded accident time permitting linkage to the closest preceding three-hour meteorological observation.
Exclusion Criteria:
- Occupational diseases, repetitive-exposure conditions, or gradual-onset disorders without a clearly defined accident date.
- Rejected, withdrawn, or unconfirmed occupational-injury claims.
- Missing or invalid accident date or geographic information preventing linkage with meteorological data.
- Accidents occurring outside the predefined geographic-climatic regions or beyond the prespecified maximum distance from an eligible meteorological station.
- Duplicate or administratively repeated records referring to the same occupational-injury event.
- Injury events for which no eligible matched control periods or corresponding meteorological measurements are available.
- Individuals younger than 18 years.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Northern valleys and inland north
Occupational injuries occurring in the northern valleys and inland northern region will be assigned to this geographic-climatic division according to the location of the workplace or accident.
Meteorological exposure will be determined using data from the nearest representative monitoring station, including Dafna, Tavor Kadoorie, or Nazareth.
This region is characterized by inland climatic conditions with substantial seasonal variation in temperature and humidity.
Accident occurrence and severity will be evaluated in relation to temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.
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Ambient temperature, relative humidity, and wind speed at the occupational-injury location and time will be retrospectively obtained from the nearest representative meteorological monitoring station.
Environmental exposures will be analyzed in relation to occupational-injury occurrence and severity.
|
|
Northern Mediterranean coast
Occupational injuries occurring along the northern Mediterranean coastal region will be assigned to this geographic-climatic division according to the location of the workplace or accident.
Meteorological exposure will be determined using data from the Haifa Technion monitoring station or the nearest available representative station.
This region is characterized by a Mediterranean coastal climate, with relatively high humidity, moderate winter temperatures, warm summers, and frequent sea-breeze effects.
Accident occurrence and severity will be evaluated in relation to ambient temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.
|
Ambient temperature, relative humidity, and wind speed at the occupational-injury location and time will be retrospectively obtained from the nearest representative meteorological monitoring station.
Environmental exposures will be analyzed in relation to occupational-injury occurrence and severity.
|
|
Central Mediterranean coast
Occupational injuries occurring within the central Mediterranean coastal region will be assigned to this geographic-climatic division according to the workplace or accident location.
Meteorological exposure will be determined using data from the Tel Aviv Coast monitoring station or the nearest available representative station.
This region is characterized by a warm Mediterranean climate, relatively high humidity, mild winters, hot summers, and frequent sea-breeze effects.
The occurrence and severity of occupational injuries will be evaluated in relation to ambient temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.
|
Ambient temperature, relative humidity, and wind speed at the occupational-injury location and time will be retrospectively obtained from the nearest representative meteorological monitoring station.
Environmental exposures will be analyzed in relation to occupational-injury occurrence and severity.
|
|
Southern Mediterranean coast
Occupational injuries occurring within the southern Mediterranean coastal region will be assigned to this geographic-climatic division according to the workplace or accident location.
Meteorological exposure will be determined using data from the Ashqelon Port monitoring station or the nearest available representative station.
This region is characterized by a warm coastal Mediterranean climate, relatively high humidity, mild winters, hot summers, and frequent sea-breeze effects.
The occurrence and severity of occupational injuries will be evaluated in relation to ambient temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.
|
Ambient temperature, relative humidity, and wind speed at the occupational-injury location and time will be retrospectively obtained from the nearest representative meteorological monitoring station.
Environmental exposures will be analyzed in relation to occupational-injury occurrence and severity.
|
|
Central highlands
Occupational injuries occurring within the central highlands region will be assigned to this geographic-climatic division according to the workplace or accident location.
Meteorological exposure will be determined using data from the Jerusalem Centre monitoring station or the nearest available representative station.
This region is characterized by higher elevation, lower average humidity than the coastal areas, greater day-night temperature variation, cooler winters, and warm, dry summers.
The occurrence and severity of occupational injuries will be evaluated in relation to ambient temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.
|
Ambient temperature, relative humidity, and wind speed at the occupational-injury location and time will be retrospectively obtained from the nearest representative meteorological monitoring station.
Environmental exposures will be analyzed in relation to occupational-injury occurrence and severity.
|
|
Negev desert
Occupational injuries occurring within the Negev desert region will be assigned to this geographic-climatic division according to the workplace or accident location.
Meteorological exposure will be determined using data from the Avdat monitoring station or the nearest available representative station.
This region is characterized by an arid desert climate, very low relative humidity, intense solar exposure, high daytime temperatures, substantial day-night temperature variation, and limited rainfall.
The occurrence and severity of occupational injuries will be evaluated in relation to ambient temperature, relative humidity, wind speed, extreme heat, extreme cold, and other predefined environmental indicators.
|
Ambient temperature, relative humidity, and wind speed at the occupational-injury location and time will be retrospectively obtained from the nearest representative meteorological monitoring station.
Environmental exposures will be analyzed in relation to occupational-injury occurrence and severity.
|
|
Dead Sea and extreme arid region
Occupational injuries occurring within the Dead Sea and extreme arid region will be assigned to this geographic-climatic division according to the workplace or accident location.
Meteorological exposure will be determined using data from the Massada monitoring station or the nearest available representative station.
This region is characterized by very low elevation, an extremely hot and arid climate, low annual rainfall, intense solar radiation, prolonged periods of extreme heat, and substantial seasonal temperature variation.
The occurrence and severity of occupational injuries will be evaluated in relation to ambient temperature, relative humidity, extreme heat, extreme cold, and other predefined environmental indicators.
Wind speed will be analyzed when reliable measurements are available.
|
Ambient temperature, relative humidity, and wind speed at the occupational-injury location and time will be retrospectively obtained from the nearest representative meteorological monitoring station.
Environmental exposures will be analyzed in relation to occupational-injury occurrence and severity.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Occurrence of Recognized Occupational Injury During Case Versus Matched Control Periods
Prazo: At the index injury date and matched control dates, January 1, 2020-December 31, 2024.
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The number of accepted occupational-injury events occurring during predefined case periods will be evaluated in relation to ambient temperature, relative humidity, and wind speed obtained from the nearest representative meteorological station.
Each injury period will be compared with control periods matched by geographic-climatic region, calendar year and month, day of the week, and three-hour time interval.
The association between environmental exposure and occupational-injury occurrence will be estimated using time-stratified case-crossover analysis with conditional logistic regression.
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At the index injury date and matched control dates, January 1, 2020-December 31, 2024.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Eytan Ellenberg, M.D., Israel National Insurance Institute
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Calkins MM, Bonauto D, Hajat A, Lieblich M, Seixas N, Sheppard L, Spector JT. A case-crossover study of heat exposure and injury risk among outdoor construction workers in Washington State. Scand J Work Environ Health. 2019 Nov 1;45(6):588-599. doi: 10.5271/sjweh.3814. Epub 2019 Mar 14.
- Sheng R, Li C, Wang Q, Yang L, Bao J, Wang K, Ma R, Gao C, Lin S, Zhang Y, Bi P, Fu C, Huang C. Does hot weather affect work-related injury? A case-crossover study in Guangzhou, China. Int J Hyg Environ Health. 2018 Apr;221(3):423-428. doi: 10.1016/j.ijheh.2018.01.005. Epub 2018 Jan 11.
- Marinaccio A, Scortichini M, Gariazzo C, Leva A, Bonafede M, De' Donato FK, Stafoggia M, Viegi G, Michelozzi P; BEEP Collaborative Group. Nationwide epidemiological study for estimating the effect of extreme outdoor temperature on occupational injuries in Italy. Environ Int. 2019 Dec;133(Pt A):105176. doi: 10.1016/j.envint.2019.105176. Epub 2019 Oct 22.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de janeiro de 2020
Conclusão Primária (Real)
31 de dezembro de 2024
Conclusão do estudo (Estimado)
31 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
2 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de agosto de 2026
Primeira postagem (Real)
6 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- BTL 001-2026
- work accidents and weather (Outro identificador: Israel National Insurance Institute)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data will not be publicly shared because the study uses confidential administrative records owned and controlled by the National Insurance Institute.
Access is restricted to authorized researchers within a secure research environment and is governed by institutional confidentiality agreements, data-protection requirements, and applicable privacy legislation.
The combination of accident dates, geographic information, occupational characteristics, and disability outcomes may create a residual risk of participant re-identification even after removal of direct identifiers.
Only aggregated, disclosure-controlled results approved by the data custodian may be reported or published.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .