Cardiovascular DiseasesEvalPsyKardNCT05480709
Evaluation of Immediate and Medium-term Health- and Work-related Effects Following Inpatient Psychocardiological Rehabilitation
An observational study of Cardiovascular Diseases and Psychiatric Disorder, run by Pensionsversicherungsanstalt at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Psychiatric Disorder
- What is being tested?
- Psychocardiological Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 119 participants
- Where
- 1 siteAustria
- Study dates
- 3 May 2021to 18 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Employed rehabilitation patients with cardiological and psychiatric illness in inpatient rehabilitation
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Rehabilitationszentrum Felbring
Muthmannsdorf, Lower Austria, 2723
About this study
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]
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
- Being tested
- Psychocardiological Rehabilitation
- Keywords
- Psychocardiology, Rehabilitation, Observational Study, Return to Work
- Medical subject headings
- Cardiovascular Diseases, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychocardiological RehabilitationBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 weeks of inpatient rehabilitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start3 May 2021
- Primary completion1 Jun 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pensionsversicherungsanstalt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doreen Stöhr, Mag., Study chair, Pensionsversicherungsanstalt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480709
- Sponsor's protocol ID
- 0005 Evaluation PsyKard
- Acronym
- EvalPsyKard
- Status last verified
- Jan 2024
- First submitted
- 25 Jul 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT05480709
- Acronym / sponsor ID
- EvalPsyKard / 0005 Evaluation PsyKard
- Conditions
- Cardiovascular Diseases, Psychiatric Disorder
- Keywords
- Psychocardiology, Rehabilitation, Observational Study, Return to Work
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- PensionsversicherungsanstaltUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Employed rehabilitation patients with cardiological and psychiatric illness in inpatient rehabilitation
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychocardiological RehabilitationPsychocardiological Rehabilitation: Regular cardiac rehabilitation with in-depth psychological and psychotherapeutic care, individual and group counseling, relaxation training, and interdisciplinary specialist psychiatric and psychosomatic visits. | Behavioural | – |
Primary outcome
Symptom-Checklist-90 - Standard (SCL-90-S)
Time frame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
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).
Herzangstfragebogen (HAF-17)
Time frame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
[Cardiac Anxiety Questionnaire - German version] Heart-focused anxiety. Minimum value = 0. Maximum value = 4. Lower values indicate less heart-focused anxiety.
Short Form-12 Health Survey (SF-12)
Time frame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
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.
Subjective work ability
Time frame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
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.
Employment status
Time frame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.
Nominal scale (Full-time employed, Employed at least part-time, Unemployed, Retired)
2 secondary outcomes
Arbeitsbezogenes Verhaltens- und Erlebensmuster (AVEM)
Time frame: 6 weeks of inpatient rehabilitation.
Social Adjustment Scale Self-Report (SAS-SR)
Time frame: 6 weeks of inpatient rehabilitation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doreen Stöhr, Mag. study chair
Pensionsversicherungsanstalt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Psychiatric Disorder, run by Pensionsversicherungsanstalt at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom-Checklist-90 - Standard (SCL-90-S) (time frame: 6 weeks of inpatient rehabilitation with follow-up assessment 6 months after rehabilitation.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.