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临床试验/NCT05480709
NCT05480709已完成不适用

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]

Pensionsversicherungsanstalt1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2021年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
119
试验地点
1
主要终点
Employment status

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Employment status

时间窗: 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)

Herzangstfragebogen (HAF-17)

时间窗: 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.

Symptom-Checklist-90 - Standard (SCL-90-S)

时间窗: 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).

Short Form-12 Health Survey (SF-12)

时间窗: 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

时间窗: 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.

次要结局

  • Arbeitsbezogenes Verhaltens- und Erlebensmuster (AVEM)(6 weeks of inpatient rehabilitation.)
  • Social Adjustment Scale Self-Report (SAS-SR)(6 weeks of inpatient rehabilitation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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