Arrhythmia, Quality of Life
Conditions
Keywords
implantable cardioverter-defibrillator, telemedicine, Home Monitoring, psychosomatic, ventricular tachyarrhythmia, quality of life, Electric Countershock
Brief summary
Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies. A close therapeutic relationship between patients and physicians, resulting in short reaction times to ICD-treated arrhythmic events and, in an optimised antiarrhythmic therapy, may help the patients to deal with their situations in the best possible way. The researchers investigate the influence of automatic remote patient monitoring on QOL, anxiety, and depression in ICD patients, and kind and frequency of (un-)scheduled patient-physician contacts. They also evaluate monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy.
Detailed description
Our study investigates the influence of automatic remote patient monitoring on quality of life (QOL), anxiety and depression in patients with implantable cardioverter-defibrillators (ICDs), and frequency of (un-)scheduled patient-physician contacts. The study also evaluates monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy. The patients will receive BIOTRONIK Lexos-T or Lumos-T ICD models, with the integrated Home Monitoring capability. The latter allows wireless, everyday transfer of the essential status and therapy data from the ICD memory to a website accessible by the attending physicians. The website is managed by BIOTRONIK Home Monitoring Service Center. Patients will be randomised into: * Group 1: Home Monitoring is established from the outset. * Group 2: Home Monitoring is introduced 9 months after ICD implantation. Follow-up for both groups is 18 months. Study Hypothesis: Home Monitoring improves the Hospital Anxiety Score in ICD patients. Preoperatively, HADS (Hospital Anxiety and Depression Scale), Questionnaire on Type D personality (DS 14), and SF-12 Questionnaire will be applied. At follow-up visits every 3 months, HADS, SF-12 Questionnaire, Shock Sensation Questionnaire, number of shocks since preceding follow-up visit, and medications (cardiovascular drugs, psychopharmacological drugs and barbiturates) will be evaluated. Home Monitoring ICD Impact Questionnaire will be collected at the final 18-month follow-up.
Interventions
DEVICEHM on
Home Monitoring activated after implantation
DEVICEHM Off
Home Monitoring activated 9 months after implantation
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for ICD implantation either as primary or secondary prevention * Patient informed consent
Exclusion criteria
* ICD replacement indication * Indication for cardiac resynchronisation therapy * Inability to fully understand psychosomatic questionnaires, especially cognitive impairment or German language deficits * Co-morbidities with a resulting life expectancy of less than one year * Psychosomatic disease (requiring psychiatric therapy) * Age \<18 years * Patients who are already enrolled in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital Anxiety and Depression Scale (HADS) anxiety score | 9 and 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (SF-12) | 9 and 18 months |
| Prevalence of Type D personality among ICD patients | 9 and 18 months |
| HADS depression score | 9 and 18 months |
| Patient's perception of ICD therapy | 9 and 18 months |
| Patient mobility | 9 and 18 months |
| Frequency of contacts between patient and physician | 9 and 18 months |
Countries
Austria, Germany, Switzerland
Outcome results
None listed