Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of legal capacity with an indication for device implantation (pacemaker, ICD, CRT, event recorder) who present at the Department of Cardiology and Angiology at the University Hospital Essen and consent to participate in the study will be included.
Disqualifiers
none
Trial population
Patients with an indication for device implantation (pacemaker, ICD, CRT, event recorder) who present at the Department of Cardiology and Angiology at the University Hospital Essen
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Survey using a questionnaire.
Other interventionsurvery over 36 months with comparison of the questionnares with risk-factors, blood-samples and physical fitness of the patient
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Patients with indication for device implantation (pacemaker, ICD, CRT, event recorder)1 intervention
Trial outcomes
Primary outcomes
1
Cumulative 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 MonthsSecondary outcomes
1
hospitalisation rate
Analyzes how often and when the Patient got hospitalized
Time frame
36 Months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov