Vocational RehabilitationNCT03752281
Long Term Social Assistance Recipient in South Eastern Sweden - a Description of Health, Function, and Activity
An observational study of Vocational Rehabilitation, run by Linkoeping University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vocational Rehabilitation
- What is being tested?
- Investigation of health and activity
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2018to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Homelessness
- Severe psychiatric illness
- Abuse of alcohol or substances
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Faculty of Health Sciences, Linköping University
Linköping, Östergötland County, SE 581 85
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Vocational Rehabilitation
- Being tested
- Investigation of health and activity
- Keywords
- Health, activity, function and long-term social assistance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigation of health and activityOther
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
| Study group | Role | What they receive |
|---|---|---|
| Health and activity | The cohort consists of long-term social assistance recipients where there is need to investigate the health status and working ability. Receives: Other: Investigation of health and activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
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.
Measured: Change between the beginning and the end of the six months intervention
Change in self-rated function and ability to be active
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.
Measured: Change between the beginning and the end of the six months intervention
Change in objective description of function and ability to be active
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.
Measured: Change between the beginning and the end of the six months intervention
Secondary outcomes (2)
Qualitative description of experiences about an increase in activity ability
Participants experiences about a change towards higher ability to be active will be described using qualitative interviews.
Measured: After the six moths intervention
Qualitative description of social workers experiences from the work with long-term social assistance recipients
Social workers experiences from their work with helping clients to get closer to the labor market will be described using qualitative interviews.
Measured: After the six moths intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vocational RehabilitationStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Linkoeping Municipality
- Responsible party
- Principal investigator, Bjorn Gerdle, Linkoeping University
- Investigators
- Linn Karlsson, PhD, Study chair, Linkoeping Municipality, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752281
- Sponsor's protocol ID
- TU-001-1811
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26436959Vogel 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.
PubMed 28358173Arends 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(12):CD006389. doi: 10.1002/14651858.CD006389.pub2.
PubMed 23235630Madden 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.
PubMed 23944180Prodinger 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.
PubMed 28988490
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Social Assistance Receipt - An Observational Study of Health, Function, and Activity
- ClinicalTrials.gov ID
- NCT03752281
- Acronym / sponsor ID
- TU-001-1811
- Conditions
- Vocational Rehabilitation
- Keywords
- Health, activity, function and long-term social assistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Linkoeping Municipality
- Study start
- Dec 2018 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health and activity | – | Other: Investigation of health and activityThe cohort consists of long-term social assistance recipients where there is need to investigate the health status and working ability. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Homelessness
- Severe psychiatric illness
- Abuse of alcohol or substances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigation of health and activityDuring 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 | Other | Health and activity |
Primary outcome
Change in quality of life
Time frame: Change between the beginning and the end of the six months intervention
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.
Change in self-rated function and ability to be active
Time frame: Change between the beginning and the end of the six months intervention
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.
Change in objective description of function and ability to be active
Time frame: Change between the beginning and the end of the six months intervention
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.
2 secondary outcomes
Qualitative description of experiences about an increase in activity ability
Time frame: After the six moths intervention
Qualitative description of social workers experiences from the work with long-term social assistance recipients
Time frame: After the six moths intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Background: PubMed 26436959van 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.
- Background: PubMed 28358173Vogel 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.
- Background: PubMed 23235630Arends 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(12):CD006389. doi: 10.1002/14651858.CD006389.pub2.
- Background: PubMed 23944180Madden 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.
- Background: PubMed 28988490Prodinger 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.
- The national board of health and welfare in SwedenLink provided by the sponsor.
- The social service actLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linn Karlsson, PhD study chair
Linkoeping Municipality, Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vocational Rehabilitation, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linn Karlsson, PhD (+46 13206675, linn.b.karlsson@linkoping.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: Change between the beginning and the end of the six months intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03752281, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.