NCT02304601

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,736

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
Last Updated

August 1, 2017

Status Verified

November 1, 2014

Enrollment Period

3.2 years

First QC Date

November 25, 2014

Last Update Submit

July 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • return-to-work

    The outcome is assessed by the discharge report from the rehabilitation centre.

    up to 9 months

Secondary Outcomes (2)

  • therapies during rehabilitation

    up to 9 months

  • socio-medical prognosis

    up to 9 months

Study Arms (2)

Comorbid symptoms

No comorbid symptoms

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Members of the German Federal Pension Insurance before their medical rehabilitation

You may qualify if:

  • Member of German Federal Pension Insurance
  • Approval of a medical rehabilitation according to § 15 SGB VI

You may not qualify if:

  • Returning questionnaire after beginning of medical rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 25185025BACKGROUND
  • 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.

    PMID: 27735981BACKGROUND
  • 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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., MPH

Study Record Dates

First Submitted

November 25, 2014

First Posted

December 2, 2014

Study Start

January 1, 2011

Primary Completion

March 1, 2014

Study Completion

September 1, 2014

Last Updated

August 1, 2017

Record last verified: 2014-11