Clinical trial NCT05480709: Evaluation of Immediate and Medium-term Health- and Work-related Effects Following Inpatient Psychocardiological Rehabilitation
Official title: Evaluation Der Unmittelbaren Und Mittelfristigen Gesundheits- Und Arbeitsbezogenen Effekte in Folge Einer Stationären Psychokardiologischen Rehabilitation [Evaluation of Immediate and Medium-term Health- and Work-related Effects Following Inpatient Psychocardiological Rehabilitation]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Psychiatric Disorder
Keywords: Psychocardiology
Rehabilitation
Observational Study
Return to Work
Lead sponsor: Pensionsversicherungsanstalt
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 119
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employed rehabilitation patients with cardiological and psychiatric illness in inpatient rehabilitation

Brief summary: Since May 2019, psychocardiological rehabilitation has been carried out at the Rehabilitation Center Felbring (RFE) in the form of a pilot project. The background is the mutual relationship of psychological and physical morbidity, which is of particular importance in cardiological rehabilitation. The present outcome evaluation study is designed as a quantitative longitudinal study with 4 repeated measures, in which at least 75 rehabilitation patients will be included. Three assessments are conducted at admission and discharge to/from inpatient rehabilitation, and an additional survey will be conducted by mail 6 months after the end of rehabilitation. Effects that become apparent as a result of rehabilitation will be recorded from a patient-centered perspective by means of "patient-reported outcomes". In this way, primarily psychological and work-related changes, but also changes in the physical quality of life are to be mapped, which can be determined immediately after completion of rehabilitation and continue in the medium term up to 6 months later.


Eligibility criteria: Inclusion Criteria:

Cardiovascular disease and increased psychological distress due to one of the following mental health diagnoses (according to ICD-10):

* Depressive Episode
* Recurrent depressive disorder
* Phobic disorders
* Anxiety disorders (incl. panic disorder)
* Acute stress reaction
* Post-traumatic stress disorder
* Adjustment disorders
* Other reactions to severe stress
* Psychological or behavioral factors that play a significant role in the etiology of physical illnesses

Exclusion Criteria:

* Acute danger to self or others
* Acute mental disorders, the extent and/or instability of which does not allow participation in rehabilitation
* High degree of neurocognitive deficits
* Highly degraded communication skills

Primary outcomes:
measure: Symptom-Checklist-90 - Standard (SCL-90-S)
timeFrame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
measure: Herzangstfragebogen (HAF-17)
timeFrame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
measure: Short Form-12 Health Survey (SF-12)
timeFrame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
measure: Subjective work ability
timeFrame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
measure: Employment status
timeFrame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
Secondary outcomes:
measure: Arbeitsbezogenes Verhaltens- und Erlebensmuster (AVEM)
timeFrame: 6 weeks of inpatient rehabilitation.
measure: Social Adjustment Scale Self-Report (SAS-SR)
timeFrame: 6 weeks of inpatient rehabilitation.
Other outcomes:
Locations:
city: Muthmannsdorf
country: Austria
facility: Rehabilitationszentrum Felbring
state: Lower Austria
Study officials:
affiliation: Pensionsversicherungsanstalt
name: Doreen Stöhr, Mag.
role: STUDY_CHAIR
References: