- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02304601
Development and Testing of a Generic Screening for Use in Application Process of Medical Rehabilitation Services (Generik)
July 28, 2017 updated by: Martin Brünger
Entwicklung Und Testung Eines Generischen Screenings für Die Vorabschätzung Von Fallgruppen im Antragsverfahren
The primary objective of this research is the development and testing of a brief cross-indication instrument (screening) for use in the approval process of medical rehabilitation services.
In addition to the empirical foundation, this generic instrument should have a high level of acceptance of both applicants and payers of rehabilitation services.
Furthermore, an everyday and economic use for the routine application process for medical rehabilitation services at the German statutory pension insurance scheme should be provided.
In the first study phase, a long instrument was tested with a sample of rehabilitees that received approval of medical rehabilitation services.
This assessment including the measurement of rehabilitation-related somatic, psychological and social impairments was first tested for its psychometric properties and then reduced to a short instrument (screening) using quantitative methods.
In the second study phase, the then-existing screening will be part of the application documents for medical rehabilitation services to assess its management properties and practicability in everyday use of the German statutory pension insurance scheme.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2736
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
Probability Sample
Study Population
Members of the German Federal Pension Insurance before their medical rehabilitation
Description
Inclusion Criteria:
- Member of German Federal Pension Insurance
- Approval of a medical rehabilitation according to § 15 SGB VI
Exclusion Criteria:
- Returning questionnaire after beginning of medical rehabilitation
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 |
---|
Comorbid symptoms
|
No comorbid symptoms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
return-to-work
Time Frame: up to 9 months
|
The outcome is assessed by the discharge report from the rehabilitation centre.
|
up to 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
therapies during rehabilitation
Time Frame: up to 9 months
|
The outcome is assessed by the discharge report from the rehabilitation centre according to the 'classification of therapeutical services'.
|
up to 9 months
|
socio-medical prognosis
Time Frame: up to 9 months
|
The outcome is assessed by the discharge report from the rehabilitation centre.
|
up to 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- Streibelt M, Brunger M. [How many work-related therapeutic services do patients with severe restrictions of work ability receive? Analysis of a representative rehabilitation sample across indications]. Rehabilitation (Stuttg). 2014 Dec;53(6):369-75. doi: 10.1055/s-0034-1375643. German.
- Brunger M, Spyra K. Prevalence of comorbid depressive symptoms in rehabilitation: A cross-indication, nationwide observational study. J Rehabil Med. 2016 Nov 11;48(10):903-908. doi: 10.2340/16501977-2156.
- Brunger M, Streibelt M, Schmidt C, Spyra K. [Psychometric Testing of a Generic Assessment Tool for the Identification of Biopsychosocial Impairments in Persons with an Approval for Medical Rehabilitation]. Rehabilitation (Stuttg). 2016 Jun;55(3):175-81. doi: 10.1055/s-0042-104668. Epub 2016 Jun 10. German.
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
January 1, 2011
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
November 25, 2014
First Submitted That Met QC Criteria
November 26, 2014
First Posted (Estimate)
December 2, 2014
Study Record Updates
Last Update Posted (Actual)
August 1, 2017
Last Update Submitted That Met QC Criteria
July 28, 2017
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 8011-106-31/31.27.16
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.
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