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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Tilburg.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014