Medical RehabilitationGenerikNCT02304601
Development and Testing of a Generic Screening for Use in Application Process of Medical Rehabilitation Services
An observational study of Medical Rehabilitation, run by Martin Brünger.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Medical Rehabilitation
- How many people
- 2,736 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Sep 2014
- 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: Members of the German Federal Pension Insurance before their medical rehabilitation
Who may be able to join
- Member of German Federal Pension Insurance
- Approval of a medical rehabilitation according to § 15 SGB VI
Who cannot join
- Returning questionnaire after beginning of medical rehabilitation
About this study
Official title: 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.
- Conditions
- Medical Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Comorbid symptoms | Not described | |
| No comorbid symptoms | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
return-to-work
The outcome is assessed by the discharge report from the rehabilitation centre.
Measured: up to 9 months
Secondary outcomes (2)
therapies during rehabilitation
The outcome is assessed by the discharge report from the rehabilitation centre according to the 'classification of therapeutical services'.
Measured: up to 9 months
socio-medical prognosis
The outcome is assessed by the discharge report from the rehabilitation centre.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startJan 2011
- Primary completionMar 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medical RehabilitationStudies of the same condition, open and under way.
- 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
- 2,736 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Brünger
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Rentenversicherung
- Responsible party
- Sponsor-investigator, Martin Brünger, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304601
- Sponsor's protocol ID
- 8011-106-31/31.27.16
- Acronym
- Generik
- Status last verified
- Nov 2014
- First submitted
- 25 Nov 2014
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25185025Brunger 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.
PubMed 27735981Brunger 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.
PubMed 27284731
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entwicklung Und Testung Eines Generischen Screenings für Die Vorabschätzung Von Fallgruppen im Antragsverfahren
- ClinicalTrials.gov ID
- NCT02304601
- Acronym / sponsor ID
- Generik / 8011-106-31/31.27.16
- Conditions
- Medical Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,736 participants (actual)
- Lead sponsor
- Martin BrüngerUniversity, hospital or other
- Collaborators
- Deutsche Rentenversicherung
- Study start
- Jan 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Dec 2014 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comorbid symptoms | – | – |
| No comorbid symptoms | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Members of the German Federal Pension Insurance before their medical rehabilitation
Key inclusion criteria (2 listed)
- Member of German Federal Pension Insurance
- Approval of a medical rehabilitation according to § 15 SGB VI
Key exclusion criteria (1 listed)
- Returning questionnaire after beginning of medical rehabilitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
return-to-work
Time frame: up to 9 months
The outcome is assessed by the discharge report from the rehabilitation centre.
2 secondary outcomes
therapies during rehabilitation
Time frame: up to 9 months
socio-medical prognosis
Time frame: up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Background: PubMed 25185025Streibelt 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.
- Background: PubMed 27735981Brunger 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.
- Results publication: PubMed 27284731Brunger 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Rehabilitation, run by Martin Brünger.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
return-to-work (time frame: up to 9 months). 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 NCT02304601, which also lists 3 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 1 Aug 2017.