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

NCT05480709 | Completed

• 1 other identifier: 0005 Evaluation PsyKard
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Psychiatric Disorder

Keywords

Psychocardiology; Rehabilitation; Observational Study; Return to Work

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Arbeitsbezogenes Verhaltens- und Erlebensmuster (AVEM)

  6 weeks of inpatient rehabilitation.

• Social Adjustment Scale Self-Report (SAS-SR)

  6 weeks of inpatient rehabilitation.

Interventions

Psychocardiological Rehabilitation BEHAVIORAL

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.

Eligibility Criteria

• Gender Eligibility Details: "male", "female", "diverse"
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Employed rehabilitation patients with cardiological and psychiatric illness in inpatient rehabilitation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pensionsversicherungsanstalt: lead

Study Sites (1)

Rehabilitationszentrum Felbring

Muthmannsdorf, Lower Austria, 2723, Austria

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Mental Disorders

Study Officials

• Doreen Stöhr, Mag.

  Pensionsversicherungsanstalt

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 29, 2022
• Study Start: May 3, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 18, 2023
• Last Updated: March 10, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)