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

Heart Diseases Clinical Trial

— WEBCARE  

Official title:

WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00895700
• Other study ID #: UVT-MP-001
• Status: Unknown status
• Phase: N/A
• First received: May 7, 2009
• Last updated: June 18, 2012
• Start date: March 2010
• Est. completion date: February 2014

Study information

• Verified date: June 2012
• Source: University of Tilburg
• Contact: Susanne S Pedersen, PhD
• Phone: 31 13 466 2503
• Email: s.s.pedersen[@]uvt.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 350
• Est. completion date: February 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Implantable Cardioverter-Defibrillators

Intervention

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

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis (OLVG)	Amsterdam	Noord-Holland
Netherlands	Amphia Hospital	Breda	Noord Brabant
Netherlands	Catharina Hospital	Eindhoven	Noord Brabant
Netherlands	Canisius-Wilhelmina Hospital	Nijmegen	Gelderland
Netherlands	Erasmus Medical Center	Rotterdam	Zuid Holland
Netherlands	Vlietland Ziekenhuis	Schiedam

Sponsors (7)

Lead Sponsor	Collaborator
University of Tilburg	Amphia Hospital, Canisius-Wilhelmina Hospital, Catharina Ziekenhuis Eindhoven, Erasmus Medical Center, Onze Lieve Vrouwe Gasthuis, Vlietland Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety		Baseline
Primary	Anxiety		14 weeks
Primary	Anxiet		26 weeks
Primary	Anxiety		52 weeks
Secondary	Cortisol awakening response		Baseline
Secondary	Cortisol awakening response		14 weeks
Secondary	Cortisol awakening response		52 weeks