Clinical trial NCT02888028: Quality of Life and Device Acceptance in Patients With ICD Undergoing Remote ICD FU
Official title: Quality of Life and Device Acceptance in Patients With Implantable Cardioverter-defibrillators Undergoing Remote ICD Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: Remote ICD follow-up
HRQoL
Health related Quality of Life
Depression
anxiety
device acceptance
telemedicine
telemonitoring
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
Collaborators: name: Klinikum Bielefeld
First posted: 2016-09-02
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients willing to participate
* Patients with new-implantation of an ICD or device replacement due to battery depletion between May 2011 and April 2013
* Sufficient knowledge of the German language
* Expectancy of life \>1 years at good clinical status
* Written informed consent

Exclusion Criteria:

* Age \<18 years
* Subjects not able to give written informed consent
* Subjects without sufficient German language skills

Primary outcomes:
measure: Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Influence of ICD remote monitoring on levels of anxiety and depression, measured by the HADS questionnaire (Hospital Anxiety and Depression scale)
timeFrame: 12 months
measure: Influence of ICD remote monitoring on device acceptance, measured by the Florida Patient acceptance scale (FPAS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Bielefeld University, School of public health
city: Munich
country: Germany
facility: Munich University Clinic, Campus Grosshadern
Study officials:
affiliation: Munich University Clinic, Campus Grosshadern, Munich, Germany
name: Johannes Siebermair, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bielefeld University, School of public health Bielefeld, Germany
name: Florian Leppert, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Munich University Clinic, Campus Grosshadern, Munich, Germany
name: Stefan Kääb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bielefeld University, School of public health, Bielefeld, Germany
name: Wolfgang Greiner, MD
role: PRINCIPAL_INVESTIGATOR
References: