Internet-based Intervention in Cardioverter-defibrillator Patients to Enhance Quality of Life
NCT ID: NCT00895700
Last Updated: 2012-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
350 participants
INTERVENTIONAL
2010-03-31
2014-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Web-based behavioral intervention
web-based multifactorial intervention
12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy
Usual care
web-based multifactorial intervention
12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy
Interventions
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web-based multifactorial intervention
12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 history of psychiatric illness other than affective/anxiety disorders
* on the waiting list for heart transplantation
* with insufficient knowledge of the Dutch language
18 Years
75 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Amphia Hospital
OTHER
Catharina Ziekenhuis Eindhoven
OTHER
Canisius-Wilhelmina Hospital
OTHER
Onze Lieve Vrouwe Gasthuis
OTHER
Vlietland Ziekenhuis
OTHER
Tilburg University
OTHER
Responsible Party
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Dr. SS Pedersen
Professor of cardiac psychology
Principal Investigators
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Susanne S Pedersen, PhD
Role: PRINCIPAL_INVESTIGATOR
Tilburg University, The Netherlands
Locations
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Canisius-Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
Amphia Hospital
Breda, North Brabant, Netherlands
Catharina Hospital
Eindhoven, North Brabant, Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, North Holland, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Vlietland Ziekenhuis
Schiedam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Habibovic M, Broers E, Heumen D, Widdershoven J, Pedersen SS, Denollet J. Optimism as predictor of patient-reported outcomes in patients with an implantable cardioverter defibrillator (data from the WEBCARE study). Gen Hosp Psychiatry. 2018 Jan-Feb;50:90-95. doi: 10.1016/j.genhosppsych.2017.10.005. Epub 2017 Nov 8.
Habibovic M, Denollet J, Cuijpers P, van der Voort PH, Herrman JP, Bouwels L, Valk SD, Alings M, Theuns DA, Pedersen SS. Web-based distress management for implantable cardioverter defibrillator patients: A randomized controlled trial. Health Psychol. 2017 Apr;36(4):392-401. doi: 10.1037/hea0000451. Epub 2017 Feb 13.
Habibovic M, Denollet J, Cuijpers P, Spek VR, van den Broek KC, Warmerdam L, van der Voort PH, Herrman JP, Bouwels L, Valk SS, Alings M, Theuns DA, Pedersen SS. E-health to manage distress in patients with an implantable cardioverter-defibrillator: primary results of the WEBCARE trial. Psychosom Med. 2014 Oct;76(8):593-602. doi: 10.1097/PSY.0000000000000096.
Habibovic M, Cuijpers P, Alings M, van der Voort P, Theuns D, Bouwels L, Herrman JP, Valk S, Pedersen S. Attrition and adherence in a WEB-Based Distress Management Program for Implantable Cardioverter defibrillator Patients (WEBCARE): randomized controlled trial. J Med Internet Res. 2014 Feb 28;16(2):e52. doi: 10.2196/jmir.2809.
Pedersen SS, Spek V, Theuns DA, Alings M, van der Voort P, Jordaens L, Cuijpers P, Denollet J, van den Broek KC. Rationale and design of WEBCARE: a randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life. Trials. 2009 Dec 23;10:120. doi: 10.1186/1745-6215-10-120.
Other Identifiers
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UVT-MP-001
Identifier Type: -
Identifier Source: org_study_id
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