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

Quality of Life and Device Acceptance in Patients With Implantable Cardioverter-defibrillators Undergoing Remote ICD Follow-up

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Procedure: ICD remote monitoring; Other: Control group

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 Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bielefeld, Germany, 33615
    • Bielefeld University, School of public health
  • Munich, Germany, 81377
    • Munich University Clinic, Campus Grosshadern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: ICD remote monitoring; ICD remote monitoring additionally to regular in-office visits
Other: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire	12 months

Secondary Outcome Measures

Outcome Measure	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)	12 months

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Collaborators: Klinikum Bielefeld
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 3, 2014
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 2, 2016

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Depression; anxiety; telemedicine; telemonitoring; HRQoL; Health related Quality of Life; device acceptance; Remote ICD follow-up
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: GE IDE MucM001-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO