NCT03752281

Brief 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. Therefore, this study aims to describe variables of health, function and activity in participants receiving long-term social assistance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

2.1 years

First QC Date

November 19, 2018

Last Update Submit

November 21, 2018

Conditions

Keywords

Health, activity, function and long-term social assistance

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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

    After the six moths intervention

  • Qualitative description of social workers experiences from the work with long-term social assistance recipients

    After the six moths intervention

Study Arms (1)

Health and activity

The cohort consists of long-term social assistance recipients where there is need to investigate the health status and working ability.

Other: Investigation of health and activity

Interventions

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

Health and activity

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Homelessness
  • Severe psychiatric illness
  • Abuse of alcohol or substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences, Linköping University

Linköping, Östergötland County, SE 581 85, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 26436959BACKGROUND
  • 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.

    PMID: 28358173BACKGROUND
  • 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(12):CD006389. doi: 10.1002/14651858.CD006389.pub2.

    PMID: 23235630BACKGROUND
  • 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.

    PMID: 23944180BACKGROUND
  • 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.

    PMID: 28988490BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Linn Karlsson, PhD

    Linkoeping Municipality, Linkoeping University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 23, 2018

Study Start

December 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

November 23, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will become available during analysis and manuscript writing. Probable for about six moths per paper.
Access Criteria
Co-authors who will be participating in analysis and manuscript preparation.

Locations