Internet-based Intervention in Cardioverter-defibrillator Patients to Enhance Quality of Life (WEBCARE)
June 18, 2012 updated by: Dr. SS Pedersen, Tilburg University
WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
350
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Schiedam, Netherlands
- Not yet recruiting
- Vlietland Ziekenhuis
-
Contact:
- Suzanne Valk, MD
- Email: svalk@ssvz.nl
-
Principal Investigator:
- Suzanne Valk, MD
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6500 GS
- Recruiting
- Canisius-Wilhelmina Hospital
-
Contact:
- L Bouwels, MD, PhD
- Email: l.bouwels@cwz.nl
-
Principal Investigator:
- L. Bouwels, MD, PhD
-
-
Noord Brabant
-
Breda, Noord Brabant, Netherlands, 4800 RL
- Recruiting
- Amphia Hospital
-
Contact:
- Marco Alings, MD, PhD
- Email: marco@alings.org
-
Principal Investigator:
- Marco Alings, MD, PhD
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Eindhoven, Noord Brabant, Netherlands, 5602 ZA
- Recruiting
- Catharina hospital
-
Contact:
- Pepijn van der Voort, MD
- Email: pepijn.vd.voort@catharina-ziekenhuis.nl
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Principal Investigator:
- Pepijn van der Voort, MD
-
-
Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1091 AC
- Recruiting
- Onze Lieve Vrouwe Gasthuis (OLVG)
-
Contact:
- J.P.R. Herrman, MD, PhD
- Email: j.p.r.herrman@olvg.nl
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Principal Investigator:
- J.P.R. Herrman, MD, PhD
-
-
Zuid Holland
-
Rotterdam, Zuid Holland, Netherlands, 3000 CB
- Recruiting
- Erasmus Medical Center
-
Contact:
- Dominic Theuns, PhD
- Email: d.theuns@erasmusmc.nl
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Principal Investigator:
- Luc Jordaens, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care
|
12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy
Other Names:
|
|
Experimental: Web-based behavioral intervention
|
12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Anxiety
Time Frame: Baseline
|
Baseline
|
|
Anxiety
Time Frame: 14 weeks
|
14 weeks
|
|
Anxiet
Time Frame: 26 weeks
|
26 weeks
|
|
Anxiety
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cortisol awakening response
Time Frame: Baseline
|
Baseline
|
|
Cortisol awakening response
Time Frame: 14 weeks
|
14 weeks
|
|
Cortisol awakening response
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susanne S Pedersen, PhD, Tilburg University, The Netherlands
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Anticipated)
February 1, 2013
Study Completion (Anticipated)
February 1, 2014
Study Registration Dates
First Submitted
May 7, 2009
First Submitted That Met QC Criteria
May 7, 2009
First Posted (Estimate)
May 8, 2009
Study Record Updates
Last Update Posted (Estimate)
June 19, 2012
Last Update Submitted That Met QC Criteria
June 18, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UVT-MP-001
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