An interventional study of ICD remote monitoring and Control group in Anxiety and Depression, sponsored by LMU Klinikum. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-21.
Sponsored by LMU Klinikum · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 182 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →LMU Klinikum is the lead sponsor of 51 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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
Procedure: ICD remote monitoring
Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU
Other: Control group
ICD remote monitoring additionally to regular in-office visits
Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU
Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire
Time frame: 12 months
Influence of ICD remote monitoring on levels of anxiety and depression, measured by the HADS questionnaire (Hospital Anxiety and Depression scale)
Time frame: 12 months
Influence of ICD remote monitoring on device acceptance, measured by the Florida Patient acceptance scale (FPAS)
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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LMU Klinikum