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

NCT00895700 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2012-06-19

No results posted yet for this study

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.

Conditions

  • Heart Diseases
  • Implantable Cardioverter-Defibrillators

Interventions

BEHAVIORAL

web-based multifactorial intervention

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

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • Amphia Hospital

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER

  • Canisius-Wilhelmina Hospital

    collaborator OTHER

  • Onze Lieve Vrouwe Gasthuis

    collaborator OTHER

  • Vlietland Ziekenhuis

    collaborator OTHER

  • Tilburg University

    lead OTHER

Principal Investigators

  • Susanne S Pedersen, PhD · Tilburg University, The Netherlands

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-02-28
Completion
2014-02-28

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00895700 on ClinicalTrials.gov