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Status unknownNCT00895700WEBCAREUpdated Jun 19, 2012

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

An interventional study of web-based multifactorial intervention in Heart Diseases and Implantable Cardioverter-Defibrillators, sponsored by Tilburg University. Status unknown at 6 sites in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-19.

Sponsored by Tilburg University · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Heart Diseases
  • Implantable Cardioverter-Defibrillators

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Keywords

  • Anxiety
  • ICD concerns
  • Quality of life
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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 350 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Tilburg University is the lead sponsor of 27 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (estimated)

Study arms

  • Experimental
    Web-based behavioral intervention

    Behavioral: web-based multifactorial intervention

  • No intervention
    Usual care

    Behavioral: web-based multifactorial intervention

Interventions

  • Behavioralweb-based multifactorial intervention

    12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy

    Also known as: Psycho-education, Cognitive behavioral therapy, Relaxation therapy

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What researchers measure

Primary outcomes

  1. Anxiety

    Time frame: Baseline

  2. Anxiety

    Time frame: 14 weeks

  3. Anxiet

    Time frame: 26 weeks

  4. Anxiety

    Time frame: 52 weeks

Secondary outcomes

  1. Cortisol awakening response

    Time frame: Baseline

  2. Cortisol awakening response

    Time frame: 14 weeks

  3. Cortisol awakening response

    Time frame: 52 weeks

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Study locations

5 of 6 sites recruiting
  • Canisius-Wilhelmina Hospital
    Nijmegen, Gelderland 6500 GS, Netherlands
    • L Bouwels, MD, PhD · Contact · l.bouwels@cwz.nl
    • L. Bouwels, MD, PhD · Principal investigator
    Recruiting
  • Amphia Hospital
    Breda, Noord Brabant 4800 RL, Netherlands
    • Marco Alings, MD, PhD · Contact · marco@alings.org
    • Marco Alings, MD, PhD · Principal investigator
    Recruiting
  • Catharina Hospital
    Eindhoven, Noord Brabant 5602 ZA, Netherlands
    Recruiting
  • Onze Lieve Vrouwe Gasthuis (OLVG)
    Amsterdam, Noord-Holland 1091 AC, Netherlands
    • J.P.R. Herrman, MD, PhD · Contact · j.p.r.herrman@olvg.nl
    • J.P.R. Herrman, MD, PhD · Principal investigator
    Recruiting
  • Erasmus Medical Center
    Rotterdam, Zuid Holland 3000 CB, Netherlands
    Recruiting
  • Vlietland Ziekenhuis
    Schiedam, Netherlands
    • Suzanne Valk, MD · Contact · svalk@ssvz.nl
    • Suzanne Valk, MD · Principal investigator
    Not yet recruiting
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References and documents

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. PubMed 29127812 ↗
  • 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. PubMed 28192003 ↗
  • 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. PubMed 25264974 ↗
  • 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. PubMed 24583632 ↗
  • 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. PubMed 20030843 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00895700
Lead sponsor
Tilburg University
Collaborators
Erasmus Medical Center, Amphia Hospital, Catharina Ziekenhuis Eindhoven, Canisius-Wilhelmina Hospital, Onze Lieve Vrouwe Gasthuis, Vlietland Ziekenhuis
Responsible party
Dr. SS Pedersen (Professor of cardiac psychology, Tilburg University) — Principal investigator
First posted
May 8, 2009
Start date
Mar 2010
Primary completion
Feb 2013 (estimated)
Completion
Feb 2014 (estimated)
Last update
Jun 19, 2012

Study contacts

Susanne S Pedersen, PhD
Contact
s.s.pedersen@uvt.nl
31 13 466 2503
Mirela Habibovic, MSc
Contact
m.habibovic@uvt.nl
31 13 466 4020
Susanne S Pedersen, PhD
principal investigator · Tilburg University, The Netherlands

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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