The project "Investigating Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation" aims to investigate the relationship between stress and the postoperative healing process of patients who have had a medical device implanted. These devices include pacemakers for the treatment of bradycardia, implantable cardioverter-defibrillators (ICDs) for the treatment of tachycardia in primary and secondary prevention, and cardiac resynchronization therapy (CRT) devices and event recorders. The study will analyze the influence of stress on the postoperative course, potential complications, and overall quality of life. A combination of medical examinations and surveys will be used to analyze how psychological stress influences the physical healing process and which measures can contribute to improving quality of life and treatment success. The surgical procedure for implanting devices is not part of the study; this is an observational study.
Study Type
OBSERVATIONAL
Enrollment
300
survery over 36 months with comparison of the questionnares with risk-factors, blood-samples and physical fitness of the patient
Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie
Essen, North Rhine-Westphalia, Germany
RECRUITINGCumulative incidence of device-related complications
Measures the incidence of device-related complications, this includes: Complications related to Device- pockets, leads and infections connected to the devices
Time frame: 36 Months
hospitalisation rate
Analyzes how often and when the Patient got hospitalized
Time frame: 36 Months
Number of participants with the following arrhythmic events: ventrikular tachykardia and ventrikular fibrillation
Following device implantation, subsequent follow-up evaluations include device interrogation to assess stored arrhythmic events. Specifically, the analysis focuses on the detection of ventricular tachycardia and ventricular fibrillation. The frequency of these arrhythmias is systematically recorded for each study participant.
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
Changes in functional capacity
changes in functional capacity will be recorded using the established 6-minute walk test. The unit of measurement for the distance covered in 6 minutes will be meters.
Time frame: Baseline (at 4-6 weeks) , after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
combined global stress measure
The outcome is based on a published RCT in Circulation by Blumenthal et al. . A global stress measure (mean rank), was the primary outcome combining the following components at baseline and following treatment: Beck Depression Inventory II, Spielberger Anxiety Inventory-State, General Health Questionnaire, PROMIS Anger Questionnaire, and Perceived Stress Scale. A range from 1 to 147 was present with higher scores suggestive of better function. The change in each individual scaled score is presented in secondary outcome. (see also NCT00981253)
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
Health-related quality of life - SF-36
The investigators will apply the Short Form-36 health questionnaire \[36,37\]. The SF-36 is an eight-dimensional scale consisting of 36 items. It assesses health-related quality of life based on physical, social, and psychological functioning, role behavior due to physical and psychological functional impairment, physical pain, general health perception, and vitality.
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
Health-related Quality of life - EQ-5D-5L
The investigators will apply the European Quality of Life 5 Dimensions 5 Level survey (EQ-5D-5L) \[36,37\]. The EQ-5D-5L consists of five health-related dimensions that can be assessed at five levels.
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
Health-related Quality of life - VAS for general health
The questionnaire contains a visual analog scale for assessing general health. It consists of a straight line from 0 to 100, with endpoints representing extreme values-such as "worst imaginable health" on one side and "best imaginable health" on the other. The participants mark a position on the line. The position of the mark provides a numerical value.
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
Depression symptoms (BDI-II)
The BDI-II is a self-report questionnaire comprising 21 items that assess depression severity. Its reliability and validity have been established through various studies among diverse populations and cultural backgrounds. Higher scores indicates increased depression symptoms
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
Anxiety symptoms (STAI)
The STAI is the most authoritative tool for assessing anxiety in adults, precisely distinguishing between transient "state anxiety" and persistent "trait anxiety". The STAI measures anxiety with 20 items and has a range of 20 to 80. A higher score indicates more pronounced anxiety
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
PROMIS-Anger Scale
The PROMIS Anger scale comprises eight items that evaluate various aspects of anger. Scores on the scale range from 8 to 40, with higher scores indicating greater levels of anger
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
GHQ, Evaluation of distress
The GHQ assesses general distress and consists of 12 items. Respondents' scores range from 0 to 36, where higher scores correspond to increased distress
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
Perceived Stress Scale
The Perceived Stress Scale-10 item version is a short tool for the assessment of how individuals perceive stress in their lives. The values range from 0 to 40. Higher values indicate higher perceived stress.
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
Appropriate vs. inappropriate Shocks
All ICD shock events occurring during the follow-up period will be classified as either appropriate or inappropriate, based on predefined criteria. Appropriate shocks will be defined as those delivered in response to documented, life-threatening ventricular arrhythmias, including: * Ventricular tachycardia (VT) * Ventricular fibrillation (VF), Inappropriate shocks will be defined as those delivered in the absence of a qualifying ventricular arrhythmia. For example: -Supraventricular tachycardias (e.g., atrial fibrillation or flutter) misclassified as VT/VF or Oversensing due to lead malfunction, signal noise, or double counting. All shock events will be reviewed using intracardiac electrograms and device event logs retrieved from the ICD or CRT-D memory. When available, surface ECG data will be used to support rhythm interpretation. A shock will only be classified as appropriate if there is clear evidence of a ventricular arrythmia
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
proinflammatory mediators- IL6
IL-6 is measured in pg/ml. Standard value is under 4.4 pg/ml. Higher values indicate an increased stress level
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
Proinflammatory mediators - CRP
C-reactive protein (CRP) is measured in mg/dl. Standard value is under 0.5 mg/dl. Higher values indicate an increased stress level.
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
Proinflammatory mediators- PCT
Procalcitonin is measured in ng/ml. Standard value is under 0.5 ng/ml. Higher values correlate with systemic inflammatory reaction and indicate bacterial infections.
Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months
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