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

NCT ID: NCT02888028

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-06-30

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.

Conditions

Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ICD remote monitoring

Intervention Type: PROCEDURE

ICD remote monitoring additionally to regular in-office visits

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

Group Type: OTHER

Control group

Intervention Type: 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

Interventions

ICD remote monitoring

ICD remote monitoring additionally to regular in-office visits

Intervention Type: PROCEDURE

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klinikum Bielefeld

OTHER

Sponsor Role: collaborator

LMU Klinikum

OTHER

Sponsor Role: lead

Responsible Party

Johannes Siebermair, MD

Johannes Siebermair, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johannes Siebermair, MD

Role: PRINCIPAL_INVESTIGATOR

Munich University Clinic, Campus Grosshadern, Munich, Germany

Florian Leppert, MSc

Role: PRINCIPAL_INVESTIGATOR

Bielefeld University, School of public health Bielefeld, Germany

Stefan Kääb, MD

Role: PRINCIPAL_INVESTIGATOR

Munich University Clinic, Campus Grosshadern, Munich, Germany

Wolfgang Greiner, MD

Role: PRINCIPAL_INVESTIGATOR

Bielefeld University, School of public health, Bielefeld, Germany

Locations

Bielefeld University, School of public health

Bielefeld, , Germany

Munich University Clinic, Campus Grosshadern

Munich, , Germany

Countries

Germany

Other Identifiers

GE IDE MucM001-11

Identifier Type: -

Identifier Source: org_study_id