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OpenTrials
Completed

NCT Number: NCT02888028

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bielefeld University, School of public health, Bielefeld, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICD remote monitoring

Procedure

ICD remote monitoring additionally to regular in-office visits

Control Group

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

Primary outcomes

  1. Influence of ICD remote monitoring on Quality of Life, measured by the EQ5D questionnaire

    Time frame: 12 months

Secondary outcomes

  1. 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

  2. Influence of ICD remote monitoring on device acceptance, measured by the Florida Patient acceptance scale (FPAS)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Collaborators

  • Klinikum Bielefeld

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2016
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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