Quality of Life and Device Acceptance in Patients With ICD Undergoing Remote ICD FU

Not Applicable

Completed

• Conditions: Anxiety; Depression
• Interventions: Other: Control group; Procedure: ICD remote monitoring

• Registration Number: NCT02888028
• Lead Sponsor: LMU Klinikum

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU
ICD remote monitoring	ICD remote monitoring	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

Primary Outcome Measures

Name	Time	Method
Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire	12 months

Secondary Outcome Measures

Name	Time	Method
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)	12 months

Trial Locations

Locations (2)

Munich University Clinic, Campus Grosshadern; 🇩🇪 Munich, Germany

Bielefeld University, School of public health; 🇩🇪 Bielefeld, Germany