Clinical trial NCT00895700: Internet-based Intervention in Cardioverter-defibrillator Patients to Enhance Quality of Life
Official title: WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
Implantable Cardioverter-Defibrillators
Keywords: Anxiety
ICD concerns
Quality of life
Lead sponsor: Tilburg University
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Amphia Hospital
name: Catharina Ziekenhuis Eindhoven
name: Canisius-Wilhelmina Hospital
name: Onze Lieve Vrouwe Gasthuis
name: Vlietland Ziekenhuis
First posted: 2009-05-08
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: 14 weeks
measure: Anxiet
timeFrame: 26 weeks
measure: Anxiety
timeFrame: 52 weeks
Secondary outcomes:
measure: Cortisol awakening response
timeFrame: Baseline
measure: Cortisol awakening response
timeFrame: 14 weeks
measure: Cortisol awakening response
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Hospital
state: Gelderland
city: Breda
country: Netherlands
facility: Amphia Hospital
state: Noord Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord Brabant
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis (OLVG)
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid Holland
city: Schiedam
country: Netherlands
facility: Vlietland Ziekenhuis
Study officials:
affiliation: Tilburg University, The Netherlands
name: Susanne S Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.