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| Name | Class |
|---|---|
| Klinikum Bielefeld | OTHER |
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This study investigates whether an additional remote follow-up of patients with implantable cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels of anxiety and depression and device acceptance. Patients are randomized to either conventional in-office FU only or additional remote surveillance, follow-up duration is 12 months. The influence of other variables (age, sex,..) is evaluated regarding their influence on study endpoints.
The rising number of implantable cardiac devices leads to an increasing amount of device-related workload, e.g. regular in-office follow-ups (FU). New means of ICD FU strategies are necessary to handle the increasing burden. ICD remote monitoring promises a time- and cost efficient alternative to conventional in-office FU strategies. Many studies have already shown benefits on FU burden reduction, on saving of costs and time, and recently on total mortality. The impact of remote ICD FU on Quality of life, anxiety and depression levels and device acceptance is still under discussion. The aim of this trial is to investigate the influence of additional remote ICD surveillance on the primary endpoint health related quality of life (HRQoL), further on levels of anxiety and depression and on device acceptance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD remote monitoring | Active Comparator | Active Comparator: ICD remote monitoring additionally to regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement |
|
| Control group | Other | Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD remote monitoring | Procedure | ICD remote monitoring additionally to regular in-office visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of ICD remote monitoring on levels of anxiety and depression, measured by the HADS questionnaire (Hospital Anxiety and Depression scale) | 12 months | |
| Influence of ICD remote monitoring on device acceptance, measured by the Florida Patient acceptance scale (FPAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Siebermair, MD | Munich University Clinic, Campus Grosshadern, Munich, Germany | Principal Investigator |
| Florian Leppert, MSc | Bielefeld University, School of public health Bielefeld, Germany | Principal Investigator |
| Stefan Kääb, MD | Munich University Clinic, Campus Grosshadern, Munich, Germany | Principal Investigator |
| Wolfgang Greiner, MD | Bielefeld University, School of public health, Bielefeld, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bielefeld University, School of public health | Bielefeld | 33615 | Germany | |||
| Munich University Clinic, Campus Grosshadern |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Other | Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU |
|
| 12 months |
| Munich |
| 81377 |
| Germany |
| D008722 | Methods |