Evaluation of Immediate and Medium-term Health- and Work-related Effects Following Inpatient Psychocardiological Rehabilitation

Cardiovascular Diseases Clinical Trial

— EvalPsyKard  

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05480709
• Other study ID #: 0005 Evaluation PsyKard
• Status: Completed
• Start date: May 3, 2021
• Est. completion date: December 18, 2023

Study information

• Verified date: January 2024
• Source: Pensionsversicherungsanstalt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 18, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Behavioral:
• Psychocardiological Rehabilitation
Psychocardiological Rehabilitation: Regular cardiac rehabilitation with in-depth psychological and psychotherapeutic care, individual and group counseling, relaxation training, and interdisciplinary specialist psychiatric and psychosomatic visits.

Locations

Country	Name	City	State
Austria	Rehabilitationszentrum Felbring	Muthmannsdorf	Lower Austria

Sponsors (1)

Lead Sponsor	Collaborator
Pensionsversicherungsanstalt

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom-Checklist-90 - Standard (SCL-90-S)	Psychological problems and symptoms of psychopathology. Minimum value (Global Severity Index) = 0. Maximum value (Global Severity Index) = 360. Lower values indicate better outcomes (i.e. less symptoms of psychopathology).	6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
Primary	Herzangstfragebogen (HAF-17)	[Cardiac Anxiety Questionnaire - German version] Heart-focused anxiety. Minimum value = 0. Maximum value = 4. Lower values indicate less heart-focused anxiety.	6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
Primary	Short Form-12 Health Survey (SF-12)	Health-related quality of life. Norm-based values (M = 50, SD = 10) for the Physical component scale (PCS) and Mental component scale (MCS). Values below 50 indicate below average (i.e. worse) physical or mental health-related quality of life. Values above 50 indicate above average (i.e. better) physical or mental health-related quality of life.	6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
Primary	Subjective work ability	Question "To what extent are you impaired in your work by your current state of health?", rated on a 10 point Likert scale, ranging from 0 = no impairment to 10 = total impairment. Lower values indicate better subjective work ability.	6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
Primary	Employment status	Nominal scale (Full-time employed, Employed at least part-time, Unemployed, Retired)	6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
Secondary	Arbeitsbezogenes Verhaltens- und Erlebensmuster (AVEM)	[Work-related behavior and experience patterns (AVEM) - German version] Work-related behavioral health risks, resources and coping. Patients are classified into four work-related behavioral and experiential patterns: G (healthy pattern), S (unambitious pattern), A (pattern at risk for overexertion) and B (pattern at risk for chronic exhaustion and resignation). Pattern G (healthy pattern) is the desirable outcome.	6 weeks of inpatient rehabilitation.
Secondary	Social Adjustment Scale Self-Report (SAS-SR)	Social adjustment / instrumental and expressive role performance at work, in social activities, and with family. Up to 54 items are rated on a five-point scale (1-5), summed and diveded by the number of items actually scored to obtain an overall mean. Lower scores indicate better social adjustment.	6 weeks of inpatient rehabilitation.