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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: 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.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.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.http://www.ClinicalTrials.gov. Identifier: NCT00895700.

SUBMITTER: Pedersen SS

PROVIDER: S-EPMC2813226 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

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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.

Pedersen Susanne S SS Spek Viola V Theuns Dominic A M J DA Alings Marco M van der Voort Pepijn P Jordaens Luc L Cuijpers Pim P Denollet Johan J van den Broek Krista C KC

Trials 20091223

<h4>Background</h4>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 patie ...[more]

PMID: 20030843

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Project description:BACKGROUND:Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter-defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter-defibrillator would reduce the incidence of sudden death during this high-risk period is unclear. METHODS:We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter-defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and nonarrhythmic death. RESULTS:Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Participants in the device group wore the device for a median of 18.0 hours per day (interquartile range, 3.8 to 22.7). Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group (relative risk, 0.67; 95% confidence interval [CI], 0.37 to 1.21; P=0.18). Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group (relative risk, 0.64; 95% CI, 0.43 to 0.98; uncorrected P=0.04), and nonarrhythmic death in 1.4% and 2.2%, respectively (relative risk, 0.63; 95% CI, 0.33 to 1.19; uncorrected P=0.15). Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock. CONCLUSIONS:Among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control. (Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965 .).

Project description:Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.

Dataset Information

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.

Publications

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.

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