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Internet-based Intervention in Cardioverter-defibrillator Patients to Enhance Quality of Life

WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00895700
Acronym
WEBCARE
Enrollment
350
Registered
2009-05-08
Start date
2010-03-31
Completion date
2014-02-28
Last updated
2012-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases, Implantable Cardioverter-Defibrillators

Keywords

Anxiety, ICD concerns, Quality of life

Brief summary

The implantable cardioverter defibrillator (ICD) is generally well-accepted by patients, but a subgroup experiences increased anxiety and poor quality of life. A web-based behavioral intervention may comprise a novel approach to reduce anxiety and enhance well-being in ICD patients, which may be equally effective and have advantages over more traditional forms of therapy, due to its low-threshold accessibility via the internet. The purpose of this study is to determine whether patients receiving a behavioral intervention via the internet experience less anxiety and device concerns and improved quality of life compared to patients receiving usual care.

Interventions

BEHAVIORALweb-based multifactorial intervention

12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy

Sponsors

Erasmus Medical Center
CollaboratorOTHER
Amphia Hospital
CollaboratorOTHER
Catharina Ziekenhuis Eindhoven
CollaboratorOTHER
Canisius-Wilhelmina Hospital
CollaboratorOTHER
Onze Lieve Vrouwe Gasthuis
CollaboratorOTHER
Vlietland Ziekenhuis
CollaboratorOTHER
Tilburg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* patients implanted with a cardioverter-defibrillator (ICD) * between 18-75 years of age * speaking and understanding Dutch * with access to the internet and ability to use the internet * providing written informed consent

Exclusion criteria

* a life expectancy less than 1 year * a history of psychiatric illness other than affective/anxiety disorders * on the waiting list for heart transplantation * with insufficient knowledge of the Dutch language

Design outcomes

Primary

MeasureTime frame
AnxietyBaseline
Anxiet26 weeks

Secondary

MeasureTime frame
Cortisol awakening responseBaseline

Countries

Netherlands

Contacts

Primary ContactSusanne S Pedersen, PhD
s.s.pedersen@uvt.nl31 13 466 2503
Backup ContactMirela Habibovic, MSc
m.habibovic@uvt.nl31 13 466 4020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026