- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03752281
Long Term Social Assistance Recipient in South Eastern Sweden - a Description of Health, Function, and Activity
November 21, 2018 updated by: 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Linn Karlsson, PhD
- Phone Number: +46 13206675
- Email: linn.b.karlsson@linkoping.se
Study Locations
-
-
Östergötland
-
Linköping, Östergötland, Sweden, SE 581 85
- Faculty of Health Sciences, Linköping University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Health and activity
The cohort consists of long-term social assistance recipients where there is need to investigate the health status and working ability.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 between the beginning and the end of the six months intervention
|
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 between the beginning and the end of the six months intervention
|
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.
|
Change between the beginning and the end of the six months intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative description of experiences about an increase in activity ability
Time Frame: After the six moths intervention
|
Participants experiences about a change towards higher ability to be active will be described using qualitative interviews.
|
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
|
Social workers experiences from their work with helping clients to get closer to the labor market will be described using qualitative interviews.
|
After the six moths intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Linn Karlsson, PhD, Linkoeping Municipality, Linkoeping University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2018
Primary Completion (Anticipated)
January 1, 2021
Study Completion (Anticipated)
January 1, 2021
Study Registration Dates
First Submitted
November 19, 2018
First Submitted That Met QC Criteria
November 21, 2018
First Posted (Actual)
November 23, 2018
Study Record Updates
Last Update Posted (Actual)
November 23, 2018
Last Update Submitted That Met QC Criteria
November 21, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- TU-001-1811
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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 Sharing Time Frame
The data will become available during analysis and manuscript writing.
Probable for about six moths per paper.
IPD Sharing Access Criteria
Co-authors who will be participating in analysis and manuscript preparation.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vocational Rehabilitation
-
PXL University CollegeJessa Hospital; RIZIV; Revalidatie & MS Centrum OverpeltCompleted
-
University Hospital of North NorwayCompletedPsychiatric Patients Experiences of Vocational Rehabilitation During Admittance in HospitalNorway
-
Human Service Center, IllinoisUnknownMental Disorders | Schizophrenia | Cognitive Symptoms | Vocational RehabilitationUnited States
-
Westfälische Wilhelms-Universität MünsterNational Paralympic Committee Germany (NPCG)CompletedCardiac Rehabilitation | Feasibility Studies | Organization and Administration | Rehabilitation ExerciseGermany
-
Asan Medical CenterRecruitingPulmonary Rehabilitation | Cardiac RehabilitationKorea, Republic of
-
University Hospital, ToursCompletedPulmonary Rehabilitation | Respiratory RehabilitationFrance
-
Suleyman Demirel UniversityCompleted
-
Orton Orthopaedic HospitalCompleted
-
Richard Watson, PTCompletedMedial Patellar Femoral Ligament Reconstruction Rehabilitation | Anterior Cruciate Ligament Reconstruction RehabilitationUnited States
-
Cairo UniversityRecruiting
Clinical Trials on Investigation of health and activity
-
Institut PasteurInstitut National de Recherche Biomédicale. Kinshasa, République Démocratique... and other collaboratorsCompletedZoonotic DiseaseCongo, The Democratic Republic of the
-
Bibi GramCompletedMusculoskeletal DiseasesDenmark
-
Mayo ClinicCompleted
-
MGH Institute of Health ProfessionsActive, not recruitingMultiple MyelomaUnited States
-
University Hospital, GrenobleUniversity Hospital, Montpellier; University Hospital, Caen; National Research... and other collaboratorsUnknownStroke | Swallowing DisordersFrance
-
University of NottinghamCompletedPain | Arthritis | Osteoarthritis | Physical Activity | Knee Osteoarthritis | Motor Activity | Sedentary | GonarthritisUnited Kingdom
-
M.D. Anderson Cancer CenterRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
Hai-Jun WangCompleted
-
Fred Hutchinson Cancer CenterRecruitingHuman Papillomavirus-Related CarcinomaUnited States
-
Duke UniversityVida Health, Inc.Completed