Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)

Study Overview
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Brief Summary
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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
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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.

Official Title
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QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring

Conditions
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Arrhythmia, Quality of Life

Intervention / Treatment
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* Device: HM on
* Device: HM Off


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Monitoring On<br>Home Monitoring activated after implantation (Intervention HM On) | Device: HM on<br>* Home Monitoring activated after implantation<br>|
| Experimental: Home Monitoring Off<br>Home Monitoring activated 9 months after implantation (Intervention HM Off) | Device: HM Off<br>* Home Monitoring activated 9 months after implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) anxiety score |  | 9 and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HADS depression score |  | 9 and 18 months | 
| Quality of life (SF-12) |  | 9 and 18 months | 
| Prevalence of Type D personality among ICD patients |  | 9 and 18 months | 
| Frequency of contacts between patient and physician |  | 9 and 18 months | 
| Patient's perception of ICD therapy |  | 9 and 18 months | 
| Patient mobility |  | 9 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implantable cardioverter-defibrillator, telemedicine, Home Monitoring, psychosomatic, ventricular tachyarrhythmia, quality of life, Electric Countershock