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:
University of Tilburg
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
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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:
|
| 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:
|
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 May 22, 2013