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

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]

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Psychiatric Disorder
• Intervention / Treatment: Behavioral: Psychocardiological Rehabilitation

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Austria
  • Lower Austria
    • Muthmannsdorf, Lower Austria, Austria, 2723
      • Rehabilitationszentrum Felbring

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Employed rehabilitation patients with cardiological and psychiatric illness in inpatient rehabilitation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Pensionsversicherungsanstalt
• Investigators: Study Chair: David Felder, Mag., Pensionsversicherungsanstalt

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Observational Study; Psychocardiology; Return to Work
• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Problem Behavior; Mental Disorders
• Other Study ID Numbers: 0005 Evaluation PsyKard

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No