- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03752281
Long Term Social Assistance Recipient in South Eastern Sweden - a Description of Health, Function, and Activity
21 de novembro de 2018 atualizado por: Bjorn Gerdle, Linkoeping University
Long Term Social Assistance Receipt - An Observational Study of Health, Function, and Activity
There is a group of social assistance recipients which have difficulties in entering the labor market and thus remains in a long-term dependency on social assistance.
More knowledge about individuals receiving long-term social assistance is needed in order to improve into work interventions for this group.
Therefore, this study aims to describe variables of health, function and activity in participants receiving long-term social assistance.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Descrição detalhada
There is a group of social assistance recipients who have difficulties in entering the labor market and thus remains in a long-term dependency on social assistance.
More knowledge about individuals receiving long-term social assistance is needed in order to improve into-work interventions for this group.
Therefore, this study aims to describe variables of health, function and activity in participants receiving long-term social assistance.
Individuals who have received social assistance during more than three years, who report physical and/or psychological difficulties, and/or have a complex social situation will be asked for participation in a six months activity-based investigation including contact with social worker, psychologist, occupational therapist, physical therapist and labor market consultant.
The intervention aims to clarify the participants hinders and resources for entering the labor market.
The participants are going to answer a questionnaire about health, function, and activity before and after the investigation.
In addition, the participants function and ability to perform activities will be classified using the International Classification of Functioning (ICF).
Data from the questionnaires and from ICF recordings will be used to describe variables of health, function and ability to be active.
Participants who manage to get closer to, or enter into, the labor market will be asked to participate in a qualitative interview study about the experiences of the change.
In addition, social workers will be asked to participate in focus-group interviews about experiences from the professional contact and work with the participants.
The quantitative data will be analysed using traditional statistics and multivariate data analysis.
Qualitative data will be analysed using qualitative content analysis.
Tipo de estudo
Observacional
Inscrição (Antecipado)
100
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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Östergötland
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Linköping, Östergötland, Suécia, SE 581 85
- Faculty of Health Sciences, Linköping University
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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
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Individuals who have been social assistance recipients for at least three years and who not have a plan how to get closer to the labor market.
There may be signs of different kinds of ill-health such as physical, pshychological and/or social ill-health.
The social worker responsible for decision about the monetary support identifies a need for establishing the working ability of the individual with the aim to agree on a plan towards self-sufficiency.
Descrição
Inclusion Criteria:
- Long-term social assistance recipient (more than three years)
- Putative ill-health (physical, psychological and/or social)
- No present plan how to reach the labor market
- Need of clarifying the working ability
Exclusion Criteria:
- Homelessness
- Severe psychiatric illness
- Abuse of alcohol or substances
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 |
|---|---|
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Health and activity
The cohort consists of long-term social assistance recipients where there is need to investigate the health status and working ability.
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During a six months multidisciplinary investigation of health status, activity and working ability for individuals receiving long-term social assistance, the health and activity status as well as function will be described using established questionnaires and the International Classification of Functioning
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in quality of life
Prazo: Change between the beginning and the end of the six months intervention
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The change in participants self-rated experience of quality of life is going to be described using EuroQol 5 Dimensions which contains a rating of the ability to perform activities, and also a score of the total quality of life experience.
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Change between the beginning and the end of the six months intervention
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Change in self-rated function and ability to be active
Prazo: Change between the beginning and the end of the six months intervention
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The change in participants self-rated function and ability to be active is going to be described using the World Health Organisation Disability Assessment Schedule (WHODAS) which contains five-grade ratings of factors including functioning, activity and participation.
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Change between the beginning and the end of the six months intervention
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Change in objective description of function and ability to be active
Prazo: Change between the beginning and the end of the six months intervention
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The change in an objective classification of function, activity, participation and environmental factors affecting disability will be described according to the International Classification of Functioning (ICF) in the beginning and at the end of the six month intervention.
The ICF contains a number of components, where each component can be scored using a five-grade scale to clarify the magnitude of disability.
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Change between the beginning and the end of the six months intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Qualitative description of experiences about an increase in activity ability
Prazo: After the six moths intervention
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Participants experiences about a change towards higher ability to be active will be described using qualitative interviews.
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After the six moths intervention
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Qualitative description of social workers experiences from the work with long-term social assistance recipients
Prazo: After the six moths intervention
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Social workers experiences from their work with helping clients to get closer to the labor market will be described using qualitative interviews.
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After the six moths intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Linn Karlsson, PhD, Linkoeping Municipality, Linkoeping University
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
- van Vilsteren M, van Oostrom SH, de Vet HC, Franche RL, Boot CR, Anema JR. Workplace interventions to prevent work disability in workers on sick leave. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD006955. doi: 10.1002/14651858.CD006955.pub3.
- Vogel N, Schandelmaier S, Zumbrunn T, Ebrahim S, de Boer WE, Busse JW, Kunz R. Return-to-work coordination programmes for improving return to work in workers on sick leave. Cochrane Database Syst Rev. 2017 Mar 30;3(3):CD011618. doi: 10.1002/14651858.CD011618.pub2.
- Arends I, Bruinvels DJ, Rebergen DS, Nieuwenhuijsen K, Madan I, Neumeyer-Gromen A, Bultmann U, Verbeek JH. Interventions to facilitate return to work in adults with adjustment disorders. Cochrane Database Syst Rev. 2012 Dec 12;12:CD006389. doi: 10.1002/14651858.CD006389.pub2.
- Madden RH, Dune T, Lukersmith S, Hartley S, Kuipers P, Gargett A, Llewellyn G. The relevance of the International Classification of Functioning, Disability and Health (ICF) in monitoring and evaluating Community-based Rehabilitation (CBR). Disabil Rehabil. 2014;36(10):826-37. doi: 10.3109/09638288.2013.821182. Epub 2013 Aug 14.
- Prodinger B, Stucki G, Coenen M, Tennant A. The measurement of functioning using the International Classification of Functioning, Disability and Health: comparing qualifier ratings with existing health status instruments. Disabil Rehabil. 2019 Mar;41(5):541-548. doi: 10.1080/09638288.2017.1381186. Epub 2017 Oct 8.
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 (Antecipado)
1 de dezembro de 2018
Conclusão Primária (Antecipado)
1 de janeiro de 2021
Conclusão do estudo (Antecipado)
1 de janeiro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
19 de novembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de novembro de 2018
Primeira postagem (Real)
23 de novembro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de novembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de novembro de 2018
Última verificação
1 de novembro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- TU-001-1811
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The co-authors will have access to the underlying interview data for the qualitative analysis.
Quantitative data will be coded and not able to identify to any participant for the co-authors.
However, it may be necessary for the co-authors to get access to the quantitative (anonymized) raw data.
Prazo de Compartilhamento de IPD
The data will become available during analysis and manuscript writing.
Probable for about six moths per paper.
Critérios de acesso de compartilhamento IPD
Co-authors who will be participating in analysis and manuscript preparation.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
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 .
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