Clinical trial NCT03206307: Spiroergometric and Psychological Measurements to Predict Return to Work After 18 and 36 Months After Medical Rehab
Official title: Spiroergometrische Und Psychologische Messungen Zur Vorhersage Der Erwerbsfähigkeit Und Rückkehr Zur Arbeit Nach 18 Und 36 Monaten Nach Der Medizinischen Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Employability
Keywords: Return to work
medical rehabilitation
Lead sponsor: Jacobs University Bremen gGmbH
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the study insured members of the Deutsche Rentenversicherung Oldenburg-Bremen with a granted medical rehabilitation treatment at the Montanus-Klinik Bad Schwalbach will be asked to fill out a questionnaire when arriving at the rehabilitation clinic as well as to take part in three subsequent telephone interviews after 6,12 and 18 months.

Brief summary: Can professional performance and the probability of returning to work up to three years after medical rehabilitation be predicted by spiroergometric data (or performance of the cardiovascular system) together with psychological factors (motivation, self-efficacy) as well as physical activity, and their interaction? How are work related and health related factors associated with the The following variables: workload, work satisfaction, personal assessment of the professional future and psychological stress?

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:

1. 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?
2. 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).

Eligibility criteria: 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

Primary outcomes:
measure: Oxygen absorption during stress test
timeFrame: 6 months
measure: Workability, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
timeFrame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
measure: Job satisfaction, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
timeFrame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
measure: Personal appraisal of the professional future, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
timeFrame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
measure: Return to working life, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
timeFrame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
measure: The handling of occupational burdens, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
timeFrame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
Secondary outcomes:
measure: 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
timeFrame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
measure: Self-imposed objectives and achievement, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
timeFrame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
measure: Personal, social and contextual factors, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
timeFrame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
measure: Participation in interventions, as measured by questionnaire - change at 6, 12 and 18 months + at 36 months after rehabilitation
timeFrame: After the rehabilitation treatment at 6, 12 and 18 months (G2) + at 36 months (G1)
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Jacobs University Bremen gGmbH
Study officials:
affiliation: Jacobs University Bremen gGmbH
name: Sonia Lippke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rinn R, Gan Y, Whittal A, Lippke S. Cardiopulmonary capacity and psychological factors are related to return to work in orthopedic rehabilitation patients. J Health Psychol. 2021 Nov;26(13):2505-2519. doi: 10.1177/1359105320913946. Epub 2020 Apr 28.