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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Monitoring On | Experimental | Home Monitoring activated after implantation (Intervention HM On) |
|
| Home Monitoring Off | Experimental | Home Monitoring activated 9 months after implantation (Intervention HM Off) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM on | Device | Home Monitoring activated after implantation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) anxiety score | 9 and 18 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Wilhelm, Dr. Med. | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus der Barmherzigen Schwestern Ried | Ried | 4910 | Austria | |||
| Hanusch-Krankenhaus |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| HM Off |
| Device |
Home Monitoring activated 9 months after implantation |
|
| 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 |
| Vienna |
| 1140 |
| Austria |
| Herzzentrum Coswig | Coswig | 06869 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Krankenhaus Martha-Maria Nürnberg | Nuremberg | 90491 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Universitätsklinikum | Zurich | Switzerland |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |