Trial document

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DRKS-ID: DRKS00009910

Trial Description

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Title

Individual courses of vocational rehabilitation: longitudinal description and evaluation of allocation and outcomes of vocational rehabilitation

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Trial Acronym

IC-VR

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Vocational rehabilitation (VR) aims to support return-to-work in persons with health-related work disability. The study examines access, processes and outcomes of VR programs in a sample of rehabilitants whose applications for VR were approved. The sample is drawn from the register of the Federal German Pension Insurance. Participants are followed up 3.5 years. The aim of the study is to describe individual courses of VR and to evaluate the process and the outcomes.

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Brief Summary in Scientific Language

Vocational rehabilitation comprises a variety of different interventions aiming at return-to-work in people experiencing limitations in work functioning. A cohort of participants with an approved application for VR will be surveyed over 3.5 years. Data collection is realized through standardized questionnaires and qualitative interviews. Additionally, administrative data on rehabilitation, welfare benefits and regular employment is used. Data will be collected up to 4 weeks after the approval and up to 8, 24 and 30 months after the approval. The study aims to describe the complex process of VR and to evaluate access, allocation, process quality and outcomes of VR. Primary outcomes are the duration of employment and income from employment. Secondary outcomes are welfare benefits (short- and long-term unemployment benefits, sickness benefits) as well as questionnaire data on health-related quality of life and self-rated work ability.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00009910
Date of Registration in DRKS: 2016/01/25
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 15-374, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein

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Secondary IDs

Universal Trial Number (UTN): U1111-1177-7639

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Health Condition or Problem studied

Free text: Risk of permanent work disability

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Interventions/Observational Groups

Arm 1: A cohort of participants with an approved application for VR will be surveyed over 3.5 years. Data collection is realized through standardized questionnaires and qualitative interviews. Additionally, administrative data on rehabilitation, welfare benefits and regular employment is used. Data will be collected up to 4 weeks after the approval and up to 8, 24 and 30 months after the approval.

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Other
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

Duration of employment, insurable remuneration and access to disability pension, data collection:
administrative data before and after VR

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Secondary Outcome

Health-related quality of life: SF-36 scale physical functioning (Bullinger & Kirchberger 1998); Self-rated work ability (Tuomi et al. 1991), data collection: up to 4 weeks after the approval (T1) and up to 8 (T2), 24 (T3) and 30 (T4) months after the approval

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

Bundesweit

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2016/02/01
Target Sample Size: 1700
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 65 Years

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Additional Inclusion Criteria

Approved application for vocational rehabilitation as provided by the Federal German Pension Insurance between January and June 2016

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Exclusion Criteria

Earlier VR during the two preceding years

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Addresses

Primary Sponsor
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- Deutsche Rentenversicherung Bund
- Ruhrstraße 2
- 10704 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- Deutsche Rentenversicherung Bund Abteilung Rehabilitation, Dez. 8024 - Zusammenarbeit mit LTA Einrichtungen, Koordination und Entwicklung
- Ms. Nadine Vorsatz
- Hohenzollerndamm 47
- 10713 Berlin
- Germany
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- Telephone: +4930-865-81584
- Fax: 7+49030-865-82122
- E-mail: nadine.vorsatz at drv-bund.de
- URL: http://www.deutsche-rentenversicherung.de/Bund/de/
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Contact for Scientific Queries
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- Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie
- Mr. Prof.Dr. Matthias Bethge
- Ratzeburger Allee 160
- 23562 Lübeck
- Germany
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- Telephone: +49451 – 50051280
- Fax: +49451 – 50051204
- E-mail: matthias.bethge at uksh.de
- URL: http://intranet.uksh.de/Sozialmedizin_Luebeck/
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Contact for Public Queries
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- Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie
- Ms. M.A. Annika Sternberg
- Ratzeburger Allee 160
- 23562 Lübeck
- Germany
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- Telephone: +49 451 929951 17
- Fax: +49451 – 50051204
- E-mail: annika.sternberg at uksh.de
- URL: http://intranet.uksh.de/Sozialmedizin_Luebeck/
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Deutsche Rentenversicherung Bund
- Ruhrstraße 2
- 10704 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up complete
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): 2019/08/31
Number of Participants in Germany after Recruiting complete: 3197
Total Number of Participants (all Sites worldwide) after Recruiting complete: 3197

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Trial Publications, Results and other Documents

Trial results: Bethge M, Sternberg A. Gesundheitliche Effekte eines Leistungsbeginns bei Personen mit bewilligter Leistung zur Teilhabe am Arbeitsleben. Die Berufliche Rehabilitation 2019; 33:126-37
Paper: Sternberg und Bethge 2022

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