- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06594120
Changes in Workability and Employment Following the Work-related Medical Rehabilitation PV RehaJET
Veränderungen Der Arbeitsfähigkeit Und Erwerbstätigkeit Infolge Des Medizinisch Berufsorientierten Rehabilitationsverfahrens PV RehaJET [Changes in Workability and Employment Following the Work-related Medical Rehabilitation PV RehaJET]
The objective of this observational study is to gain insight into a new approach to rehabilitation in Austria, with a particular focus on work-specific exercises that are dependent on the specific work-related needs of the patients. Two groups are being observed: one was referred to a three-week work-specific rehabilitation programme immediately upon arrival at the rehabilitation centre, while the other group underwent a three-week medical-focused rehabilitation programme before starting a four-week work-specific rehabilitation programme.
Researchers will monitor for indications of improvement following completion of the rehabilitation program. As the two forms of rehabilitation are not directly comparable, they will be observed and analysed as two distinct entities.
As part of their regular inpatient rehabilitation, participants will complete questionnaires at designated intervals (beginning and end of stay), with follow-up assessments scheduled at six and 12 months post-rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stefan Gschwenter, MA
- Phone Number: +43 50303 - 26722
- Email: stefan.gschwenter@pv.at
Study Locations
-
-
Salzburg
-
Bad Hofgastein, Salzburg, Austria, 5630
- Recruiting
- Rehabilitationszentrum Bad Hofgastein
-
Contact:
- Martin Pelitz, Dr.
- Phone Number: +4364326685
- Email: martin.pelitz@pv.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The study participants are regular patients in the rehabilitation centre Bad Hofgastein
- Presence of a disease in the area of the musculoskeletal system
- Sufficient motivation to maintain professional participation
- Declaration of consent
Exclusion Criteria:
- No completion of all work-specific rehabilitation modules
- Acute or decompensated disease states with severe functional limitations (i.e. not able to continue with the rehabilitation programme)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
3-week work-specific rehabilitation
This group is referred to the work-specific rehabilitation programme immediately upon arrival at the rehabilitation centre.
|
The rehabilitation is based on the biopsychosocial ICF model of the WHO.
Taking into account the physical and psychological condition of the patients, an individual therapy plan is created that is tailored to the needs of the patients.
|
|
4-week work-specific rehabilitation
This group first underwent a three-week medical-focused rehabilitation programme prior to commencing the work-specific rehabilitation programme.
|
The rehabilitation is based on the biopsychosocial ICF model of the WHO.
Taking into account the physical and psychological condition of the patients, an individual therapy plan is created that is tailored to the needs of the patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IMBA - Profile comparison
Time Frame: 3 or 4 weeks of inpatient rehabilitation
|
IMBA is a profile comparison method for prevention and rehabilitation.
Job requirements and human capabilities are described by standardised, defined characteristics and compared directly with each other.
The respective profile sheets consist, among other things, of 70 function-, activity- and context-related main characteristics in which the extent of excessive demands for each characteristic is documented on a scale of 0 - 6 (Min.
= 0, Max = 420).
Lower values indicate less excessive demands.
|
3 or 4 weeks of inpatient rehabilitation
|
|
Employment history
Time Frame: 6 and 12 months after finishing rehabilitation
|
The existence of gainful employment subject to social insurance contributions in a specific period allows conclusions to be drawn about the employment history of the rehabilitants.
|
6 and 12 months after finishing rehabilitation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Work ability index (WAI)
Time Frame: 3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation
|
The Work Ability Index (WAI) is an instrument for assessing work ability.
(Min.
= 7, Max = 49).
Lower values indicate less subjective work ability.
|
3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation
|
|
Patient Health Questionnaire-4 (PHQ-4)
Time Frame: 3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation
|
The Patient Health Questionnaire-4 (PHQ-4) operationalizes core criteria for anxiety and depression on a 4 point likert scale (Min.
= 0, Max = 4).
Lower values indicate less impairments.
|
3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation
|
|
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
Time Frame: 3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation
|
The EQ-5D-5L is a general instrument for measuring patient-reported outcomes (PROs), which can be used to assess the quality of life of patients on different dimensions (mobility, self-care, usual activities, pain/discomfort) on a 5-level scale (Min. = 0, Max. = 5). Lower values indicate less impairments in the respective dimensions. Moreover, the EQ-5D-5L assesses the patient's self-rated health on a 100 point visual analog scale (Min. = 0, Max. = 100). Lower values indicate less positive ratings of health. |
3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Doreen Stöhr, Mag., Pensionsversicherungsanstalt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0031 Studie PVRehaJET als EV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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