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Published in: Trials 1/2009

Open Access 01-12-2009 | Study protocol

Rationale and design of WEBCARE: A randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life

Authors: Susanne S Pedersen, Viola Spek, Dominic AMJ Theuns, Marco Alings, Pepijn van der Voort, Luc Jordaens, Pim Cuijpers, Johan Denollet, Krista C van den Broek

Published in: Trials | Issue 1/2009

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Abstract

Background

The implantable cardioverter defibrillator (ICD) is generally well accepted, but 25-33% of patients experience clinical levels of anxiety, depression, and impaired quality of life (QoL) following implantation. Few trials in ICD patients have investigated whether behavioral intervention may mitigate the development of these adjustment problems. We present the rationale and study design of the WEB-based distress management program for implantable CAR dioverter dE fibrillator patients (WEBCARE) trial.

Methods

WEBCARE is a multi-center, multi-disciplinary, randomized, controlled behavioral intervention trial designed to examine the effectiveness of a web-based approach in terms of reducing levels of anxiety and device concerns and enhancing QoL. Consecutive patients hospitalized for the implantation of an ICD will be approached for study participation while in hospital and randomized to the intervention arm (n = 175) versus usual care (n = 175) at baseline (5-10 days post implantation). Patients will complete assessments of patient-centered outcomes at baseline, 14, 26, and 52 weeks after implantation. Patients randomized to the intervention arm will receive a 12-week web-based behavioral intervention starting 2 weeks after implantation. Primary endpoints include (ii) patient-centered outcomes (i.e., anxiety, depression, ICD acceptance, QoL); (iii) health care utilization; and (iiii) cost-effectiveness. All primary endpoints will be assessed with standardized and validated disease-specific or generic questionnaires. Secondary endpoints include (iii) cortisol awakening response; and (iiii) ventricular arrhythmias.

Discussion

WEBCARE will show whether a behavioral intervention using a web-based approach is feasible and effective in reducing anxiety and ICD concerns and improving QoL in ICD patients.

Trial Registration

http://​www.​ClinicalTrials.​gov. Identifier: NCT00895700.
Appendix
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Metadata
Title
Rationale and design of WEBCARE: A randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life
Authors
Susanne S Pedersen
Viola Spek
Dominic AMJ Theuns
Marco Alings
Pepijn van der Voort
Luc Jordaens
Pim Cuijpers
Johan Denollet
Krista C van den Broek
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Trials / Issue 1/2009
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-10-120

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