Heart DiseasesWEBCARENCT00895700
Internet-based Intervention in Cardioverter-defibrillator Patients to Enhance Quality of Life
A study testing web-based multifactorial intervention in people with Heart Diseases and Implantable Cardioverter-Defibrillators, run by Tilburg University at 6 sites in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Diseases, Implantable Cardioverter-Defibrillators
- What is being tested?
- web-based multifactorial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 6 sitesNetherlands
- Study dates
- Mar 2010to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Recruiting
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, North Holland, 1091 AC
J.P.R. Herrman, MD, PhD, j.p.r.herrman@olvg.nl
J.P.R. Herrman, MD, PhD
- Recruiting
Amphia Hospital
Breda, North Brabant, 4800 RL
Marco Alings, MD, PhD, marco@alings.org
Marco Alings, MD, PhD
- Recruiting
Catharina Hospital
Eindhoven, North Brabant, 5602 ZA
Pepijn van der Voort, MD, pepijn.vd.voort@catharina-ziekenhuis.nl
Pepijn van der Voort, MD
- Recruiting
Canisius-Wilhelmina Hospital
Nijmegen, Gelderland, 6500 GS
L Bouwels, MD, PhD, l.bouwels@cwz.nl
L. Bouwels, MD, PhD
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3000 CB
Dominic Theuns, PhD, d.theuns@erasmusmc.nl
Luc Jordaens, MD, PhD
- Not yet recruiting
Vlietland Ziekenhuis
Schiedam
Suzanne Valk, MD, svalk@ssvz.nl
Suzanne Valk, MD
About this study
Official title: 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.
- Being tested
- web-based multifactorial intervention
- Keywords
- Anxiety, ICD concerns, Quality of life
- Medical subject headings
- Heart Diseases, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based multifactorial interventionBehavioural
Also called Psycho-education, Cognitive behavioral therapy, Relaxation therapy
12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy
| Study group | Role | What they receive |
|---|---|---|
| Web-based behavioral intervention | Experimental | Not described Receives: Behavioral: web-based multifactorial intervention |
| Usual care | No intervention | Not described Receives: Behavioral: web-based multifactorial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Measured: Baseline
Anxiety
Measured: 14 weeks
Anxiet
Measured: 26 weeks
Anxiety
Measured: 52 weeks
Secondary outcomes (3)
Cortisol awakening response
Measured: Baseline
Cortisol awakening response
Measured: 14 weeks
Cortisol awakening response
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startMar 2010
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Amphia Hospital, Catharina Ziekenhuis Eindhoven, Canisius-Wilhelmina Hospital, Onze Lieve Vrouwe Gasthuis, Vlietland Ziekenhuis
- Responsible party
- Principal investigator, Dr. SS Pedersen, Tilburg University
- Investigators
- Susanne S Pedersen, PhD, Principal investigator, Tilburg University, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895700
- Sponsor's protocol ID
- UVT-MP-001
- Acronym
- WEBCARE
- Status last verified
- Jun 2012
- First submitted
- 7 May 2009
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
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 29127812Habibovic 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 28192003Habibovic 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 25264974Habibovic 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 24583632Pedersen 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial
- ClinicalTrials.gov ID
- NCT00895700
- Acronym / sponsor ID
- WEBCARE / UVT-MP-001
- Keywords
- Anxiety, ICD concerns, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Amphia Hospital, Catharina Ziekenhuis Eindhoven, Canisius-Wilhelmina Hospital, Onze Lieve Vrouwe Gasthuis, Vlietland Ziekenhuis
- Study start
- Mar 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 8 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based behavioral intervention | Experimental | Behavioral: web-based multifactorial intervention |
| Usual care | No intervention | Behavioral: web-based multifactorial intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based multifactorial interventionAlso: Psycho-education, Cognitive behavioral therapy, Relaxation therapy12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy | Behavioural | Usual care, Web-based behavioral intervention |
Primary outcome
Anxiety
Time frame: Baseline
Anxiety
Time frame: 14 weeks
Anxiet
Time frame: 26 weeks
Anxiety
Time frame: 52 weeks
3 secondary outcomes
Cortisol awakening response
Time frame: Baseline
Cortisol awakening response
Time frame: 14 weeks
Cortisol awakening response
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
- Derived from this study: PubMed 29127812Habibovic 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.
- Derived from this study: PubMed 28192003Habibovic 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.
- Derived from this study: PubMed 25264974Habibovic 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.
- Derived from this study: PubMed 24583632Habibovic 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.
- Derived from this study: PubMed 20030843Pedersen 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.
Related trials for Heart Diseases
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne S Pedersen, PhD principal investigator
Tilburg University, The Netherlands
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based multifactorial intervention in people with Heart Diseases and Implantable Cardioverter-Defibrillators, run by Tilburg University at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanne S Pedersen, PhD (31 13 466 2503, s.s.pedersen@uvt.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00895700, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.