- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03752281
Long Term Social Assistance Recipient in South Eastern Sweden - a Description of Health, Function, and Activity
21. november 2018 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Linn Karlsson, PhD
- Telefonnummer: +46 13206675
- E-mail: linn.b.karlsson@linkoping.se
Studiesteder
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Östergötland
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Linköping, Östergötland, Sverige, SE 581 85
- Faculty of Health Sciences, Linköping University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in quality of life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Qualitative description of experiences about an increase in activity ability
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Linn Karlsson, PhD, Linkoeping Municipality, Linkoeping University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. december 2018
Primær færdiggørelse (Forventet)
1. januar 2021
Studieafslutning (Forventet)
1. januar 2021
Datoer for studieregistrering
Først indsendt
19. november 2018
Først indsendt, der opfyldte QC-kriterier
21. november 2018
Først opslået (Faktiske)
23. november 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- TU-001-1811
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
The data will become available during analysis and manuscript writing.
Probable for about six moths per paper.
IPD-delingsadgangskriterier
Co-authors who will be participating in analysis and manuscript preparation.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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