Internet-based Intervention in Cardioverter-defibrillator Patients to Enhance Quality of Life
WEBCARE
WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial
1 other identifier
interventional
350
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2009
CompletedFirst Posted
Study publicly available on registry
May 8, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJune 19, 2012
June 1, 2012
2.9 years
May 7, 2009
June 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Anxiety
Baseline
Anxiety
14 weeks
Anxiet
26 weeks
Anxiety
52 weeks
Secondary Outcomes (3)
Cortisol awakening response
Baseline
Cortisol awakening response
14 weeks
Cortisol awakening response
52 weeks
Study Arms (2)
Web-based behavioral intervention
EXPERIMENTALUsual care
NO INTERVENTIONInterventions
12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tilburg Universitylead
- Erasmus Medical Centercollaborator
- Amphia Hospitalcollaborator
- Catharina Ziekenhuis Eindhovencollaborator
- Canisius-Wilhelmina Hospitalcollaborator
- Onze Lieve Vrouwe Gasthuiscollaborator
- Vlietland Ziekenhuiscollaborator
Study Sites (6)
Canisius-Wilhelmina Hospital
Nijmegen, Gelderland, 6500 GS, Netherlands
Amphia Hospital
Breda, North Brabant, 4800 RL, Netherlands
Catharina Hospital
Eindhoven, North Brabant, 5602 ZA, Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, North Holland, 1091 AC, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, 3000 CB, Netherlands
Vlietland Ziekenhuis
Schiedam, Netherlands
Related Publications (5)
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.
PMID: 29127812DERIVEDHabibovic 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.
PMID: 28192003DERIVEDHabibovic 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.
PMID: 25264974DERIVEDHabibovic 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.
PMID: 24583632DERIVEDPedersen 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.
PMID: 20030843DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne S Pedersen, PhD
Tilburg University, The Netherlands
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of cardiac psychology
Study Record Dates
First Submitted
May 7, 2009
First Posted
May 8, 2009
Study Start
March 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2014
Last Updated
June 19, 2012
Record last verified: 2012-06