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

This study is currently recruiting participants.
Verified June 2012 by University of Tilburg
Sponsor:
Collaborators:
Erasmus Medical Center
Amphia Hospital
Catharina Ziekenhuis Eindhoven
Canisius-Wilhelmina Hospital
Onze Lieve Vrouwe Gasthuis
Vlietland ziekenhuis
Information provided by (Responsible Party):
Dr. SS Pedersen, University of Tilburg
ClinicalTrials.gov Identifier:
NCT00895700
First received: May 7, 2009
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Heart Diseases
Implantable Cardioverter-Defibrillators
Behavioral: web-based multifactorial intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial

Resource links provided by NLM:


Further study details as provided by University of Tilburg:

Primary Outcome Measures:
  • Anxiety [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Anxiet [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cortisol awakening response [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Cortisol awakening response [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Cortisol awakening response [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: March 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Web-based behavioral intervention Behavioral: web-based multifactorial intervention
12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy
Other Names:
  • Psycho-education
  • Cognitive behavioral therapy
  • Relaxation therapy
No Intervention: Usual care Behavioral: web-based multifactorial intervention
12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy
Other Names:
  • Psycho-education
  • Cognitive behavioral therapy
  • Relaxation therapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895700

Contacts
Contact: Susanne S Pedersen, PhD 31 13 466 2503 s.s.pedersen@uvt.nl
Contact: Mirela Habibovic, MSc 31 13 466 4020 m.habibovic@uvt.nl

Locations
Netherlands
Canisius-Wilhelmina Hospital Recruiting
Nijmegen, Gelderland, Netherlands, 6500 GS
Contact: L Bouwels, MD, PhD       l.bouwels@cwz.nl   
Principal Investigator: L. Bouwels, MD, PhD         
Amphia Hospital Recruiting
Breda, Noord Brabant, Netherlands, 4800 RL
Contact: Marco Alings, MD, PhD       marco@alings.org   
Principal Investigator: Marco Alings, MD, PhD         
Catharina Hospital Recruiting
Eindhoven, Noord Brabant, Netherlands, 5602 ZA
Contact: Pepijn van der Voort, MD       pepijn.vd.voort@catharina-ziekenhuis.nl   
Principal Investigator: Pepijn van der Voort, MD         
Onze Lieve Vrouwe Gasthuis (OLVG) Recruiting
Amsterdam, Noord-Holland, Netherlands, 1091 AC
Contact: J.P.R. Herrman, MD, PhD       j.p.r.herrman@olvg.nl   
Principal Investigator: J.P.R. Herrman, MD, PhD         
Erasmus Medical Center Recruiting
Rotterdam, Zuid Holland, Netherlands, 3000 CB
Contact: Dominic Theuns, PhD       d.theuns@erasmusmc.nl   
Principal Investigator: Luc Jordaens, MD, PhD         
Vlietland Ziekenhuis Not yet recruiting
Schiedam, Netherlands
Contact: Suzanne Valk, MD       svalk@ssvz.nl   
Principal Investigator: Suzanne Valk, MD         
Sponsors and Collaborators
University of Tilburg
Erasmus Medical Center
Amphia Hospital
Catharina Ziekenhuis Eindhoven
Canisius-Wilhelmina Hospital
Onze Lieve Vrouwe Gasthuis
Vlietland ziekenhuis
Investigators
Principal Investigator: Susanne S Pedersen, PhD Tilburg University, The Netherlands
  More Information

No publications provided by University of Tilburg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. SS Pedersen, Professor of cardiac psychology, University of Tilburg
ClinicalTrials.gov Identifier: NCT00895700     History of Changes
Other Study ID Numbers: UVT-MP-001
Study First Received: May 7, 2009
Last Updated: June 18, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University of Tilburg:
Anxiety
ICD concerns
Quality of life

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014