title: 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.
abstract: BACKGROUND
  The implantable cardioverter defibrillator (ICD) is generally well accepted, but 25-33% of patients experience clinical levels of anxiety, depression, and impaired quality of life (QoL) following implantation. Few trials in ICD patients have investigated whether behavioral intervention may mitigate the development of these adjustment problems. We present the rationale and study design of the WEB-based distress management program for implantable CARdioverter dEfibrillator patients (WEBCARE) trial.
  
  
  METHODS
  WEBCARE is a multi-center, multi-disciplinary, randomized, controlled behavioral intervention trial designed to examine the effectiveness of a web-based approach in terms of reducing levels of anxiety and device concerns and enhancing QoL. Consecutive patients hospitalized for the implantation of an ICD will be approached for study participation while in hospital and randomized to the intervention arm (n = 175) versus usual care (n = 175) at baseline (5-10 days post implantation). Patients will complete assessments of patient-centered outcomes at baseline, 14, 26, and 52 weeks after implantation. Patients randomized to the intervention arm will receive a 12-week web-based behavioral intervention starting 2 weeks after implantation. Primary endpoints include (i(i)) patient-centered outcomes (i.e., anxiety, depression, ICD acceptance, QoL); (i(ii)) health care utilization; and (i(iii)) cost-effectiveness. All primary endpoints will be assessed with standardized and validated disease-specific or generic questionnaires. Secondary endpoints include (ii(i)) cortisol awakening response; and (ii(ii)) ventricular arrhythmias.
  
  
  CONCLUSIONS
  WEBCARE will show whether a behavioral intervention using a web-based approach is feasible and effective in reducing anxiety and ICD concerns and improving QoL in ICD patients.
  
  
  BACKGROUND
  http://www.ClinicalTrials.gov. Identifier: NCT00895700.
authors.affiliation: CoRPS, Department of Medical Psychology, Tilburg University, Tilburg, the Netherlands. s.s.pedersen@uvt.nl
authors.forename: Susanne S
authors.initials: SS
authors.lastname: Pedersen
authors.forename: Viola
authors.initials: V
authors.lastname: Spek
authors.forename: Dominic A M J
authors.initials: DA
authors.lastname: Theuns
authors.forename: Marco
authors.initials: M
authors.lastname: Alings
authors.forename: Pepijn
authors.initials: P
authors.lastname: van der Voort
authors.forename: Luc
authors.initials: L
authors.lastname: Jordaens
authors.forename: Pim
authors.initials: P
authors.lastname: Cuijpers
authors.forename: Johan
authors.initials: J
authors.lastname: Denollet
authors.forename: Krista C
authors.initials: KC
authors.lastname: van den Broek
mesh_terms: D001007:Anxiety / Q000517:prevention & control*; D001145:Arrhythmias, Cardiac / Q000523:psychology* / Q000628:therapy*; D017147:Defibrillators, Implantable / Q000523:psychology*; D003863:Depression / Q000517:prevention & control; D015438:Health Behavior; D006801:Humans; D006854:Hydrocortisone / Q000378:metabolism; D020407:Internet; D017060:Patient Satisfaction; D011788:Quality of Life; D012463:Saliva / Q000378:metabolism
chemical_list: D006854:Hydrocortisone