- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03206307
Spiroergometric and Psychological Measurements to Predict Return to Work After 18 and 36 Months After Medical Rehab (SPIRO)
Spiroergometrische Und Psychologische Messungen Zur Vorhersage Der Erwerbsfähigkeit Und Rückkehr Zur Arbeit Nach 18 Und 36 Monaten Nach Der Medizinischen Rehabilitation
Study Overview
Status
Conditions
Detailed Description
One main aim of medical rehabilitation is to restore ability to work. The goal is to increase health, as well as the performance and functional capacity of the the rehabilitant, in order to improve their occupational ability, as well as social activity and participation.
A number of the psychological and structural factors involved in this are already known. There is less evidence, however, regarding the importance of objectively measured performance and functioning, as well as the relation of these objective measures with subjective factors (i.e., the interaction of cardiovascular performance and physical activity with psychological factors with).
Therefore, this study investigates how rehabilitants can successfully decrease their professional vulnerability, and the importance of spiroergometric and psychological data to predict viability and return to work.
The aim is to improve the theorised variance in predicting the viability and return to work and, based on the results, to make appropriate recommendations to those affected and their social network, rehabilitation facilities, those offering rehabilitation services, employers and physicians.
The following research questions are to be answered with this study:
Can spiroergometric data and psychological mechanisms characterize:
(A) workability and physical activity, (B) self assessment of the professional future, (C) return to working life, (D) ability to deal with occupational burdens (professional capacity)
... 6, 12, 18 and 36 months after medical rehabilitation?
- What is the significance of objective data compared to subjective characteristics (such as "higher level goals" in terms of employment), and how are the mediating psychological mechanisms involved?
In rehabilitation patients with degenerative skeletal diseases, a spiroergometry measurement (cardiovascular checkup) was carried out in 2013/2014 (group 1, G1). This study determined the performance of the cardiovascular system and the general "fitness". The patients were also questioned about age, workload, work satisfaction, assessment of the future of the profession and accompanying psychological stress.
A follow-up survey of those who are insured is to be carried out by telephone.
In addition, new patients (group 2, G2) are to be interviewed and spiroergometrically tested, as well as to be interviewed three times over the phone.
This will allow: (1) analyzing the change over time and the cardiovascular capacity beyond psychological factors (motivation, self-efficacy) and physical activity, (2) comparisons with other insured persons.
Data collection after rehabilitation is carried out as a computer-assisted telephone interview, and is conducted after the rehabilitation after 6, 12, 18 (G2) and 36 months (G1).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bremen, Germany, 28759
- Jacobs University Bremen gGmbH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Degenerative skeletal disease
- Medical rehabilitation at Montanus-Klinik Bad Schwalbach
- Insured with the Deutsche Rentenversicherung Oldenburg-Bremen
- Sufficient knowledge of the German language
- Telephone or mobile phone connection
Exclusion Criteria:
- Insufficient knowledge of the German language
- No participation in the spiroergometrical measurement
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
Group 1 will be questioned 36 months (in 2017) after their medical rehabilitation which was in 2013/2014.
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Group 2
Group 2 has the medical rehabilitation in 2017 and will be questioned at the end of the medical rehabilitation and 6, 12 and 18 months after that
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Oxygen absorption during stress test
Time Frame: 6 months
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Measured by VO2MAX (maximum oxygen consumption in ml / kg body weight / min)
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6 months
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Workability, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time Frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Parameters include health status, employment history, current position, working hours, physical, mental or emotional restrictions to work
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After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Job satisfaction, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time Frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Parameters include earning capacity, whether job is mentally/physically/emotionally/inter-personally exhausting, skills required, whether recognition is received, independence, boring/challenging , overwhelming, continuous learning, whether important to the person
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After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Personal appraisal of the professional future, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time Frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Parameters include whether individual expects future work difficulties professionally and/or due to health restrictions
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After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Return to working life, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time Frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Parameters include how many hours individual desires to work again
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After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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The handling of occupational burdens, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time Frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Parameters include personal initiatives to make return to work practical: changing working conditions, reduction in work hours, different position, professional training, attended health promoting courses, attended coaching/counseling, engaged in self-help, lifestyle changes
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After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plans to participate and wishes to take measures to safeguard the earning capacity, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time Frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Parameters include personal reasons to safeguard earning capacity: money, feeling needed, interpersonal contact, recognition, knowledge/experience, fun, routine, development, mentally fitness, being outside the home, purpose in life, expectations from others, physical fitness, distraction from other problems
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After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Self-imposed objectives and achievement, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time Frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Parameters include personal objectives to achieve from rehabilitation: improved mobility, improved physical condition, improved physical illness and complaints, improved mental condition, improved interpersonal situation, improved professional situation, improved working capacity, weight loss, pain reduction, overall health promotion, deal with daily stress, more confidence
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After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Personal, social and contextual factors, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time Frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Parameters include: perceived job security, earning capacity risk, satisfaction with life, satisfaction with job-related activities, satisfaction with physical activity, social support, self-efficacy
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After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Participation in interventions, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
Time Frame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Parameters include participation in: medical treatments, psychological therapies, disease-specific group training, physical therapy, movement therapy, general health training, work-related measures, professional advice, relaxation techniques
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After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
Keywords
Other Study ID Numbers
- 060.001.12.00 - 3.050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Employability
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Jacobs University Bremen gGmbHCompleted