- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00846417
Implantable Cardioverter Defibrillator (ICD) Support Groups and Veterans
Impact of ICD Support Groups in Veterans Receiving Internal Cardioverter Defibrillators
Panoramica dello studio
Stato
Descrizione dettagliata
Sudden cardiac death (SCD) is a major clinical problem, responsible for 400,000 deaths annually in the US(2) Ventricular fibrillation/ventricular tachycardia (VF/VT) is the most common arrhythmia associated with SCD(3). ICD implantation is the only preventive treatment, and clinical trials have clearly established the efficacy of ICD placement for both primary and secondary prevention of SCD(4). Since 1996, ICD implantation has increased dramatically, from 20,000 per year, to 200,000 implanted per year in the US.
Patients are likely to experience varying degrees of psychological, social and physical adjustment both leading up to and following ICD implant. Poor quality of life and depression are common in patients with ICD(5). Anxiety is particularly common, with approximately 24 - 87% of ICD recipients experiencing increased symptoms of anxiety after implantation and diagnostic rates for clinically significant anxiety disorders ranging from 13-38%(6). The occurrence of ICD shocks is generally faulted for this psychological distress, but its causal influence is confounded by the presence of a life threatening medical condition. Depressive symptoms are reported in 24-33% of ICD patients(7). ICD shock related fears are universal and may be the most pervasive psychosocial adjustment challenge ICD patients face.
The literature suggests that ICD recipient QOL is not as high as that among recipients of more benign cardiac devices such as pacemakers. Concerns about ICD shocks and the negative effect of ICDs on patients' sense of control, social interactions, driving, sexuality, capacity to work, and ability to engage in leisure activities appear to adversely influence ICD recipients' perception of health and well being(8).
Support groups are a popular adjunctive treatment for ICD patients because they provide an efficient conduit for patient education spanning the biopsychosocial domains.(9) The active ingredients of support groups probably centre on the universality of many patient concerns and the sharing of information and strategies to deal effectively with these concerns. Dickerson et al found that ICD recipients and their support persons coped with traumatic experience of sudden cardiac death by using story telling in the support group to work through the anxiety and place the event into a manageable explanation(10). Clinical nurse specialist (CNS) - facilitated support group are beneficial if offered, especially if they contact the ICD recipients early during hospitalization and making them aware of this resource(11).
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Screen for enrollment into 2 groups - ICD support group and non ICD support group, consented, baseline set of QOL questionnaires
Exclusion Criteria:
- Patients that experience varying degrees of psychological, social and physical adjustment both leading up to and following ICD.
- Poor quality of life and depression.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
---|
Case
Patients with ICDs who attend the ICD Support Groups.
|
Control
Patients with ICDs who do not attend the ICD support groups.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
All veterans visiting the Atlanta Veterans Administration Medical Center will be screened and enrolled into 2 groups: ICD support group and Non ICD support group.
Lasso di tempo: Documented nine months after the time of enrollment.
|
Documented nine months after the time of enrollment.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
This study is observational. It entails questionnaires after enrollment regarding assessing the baseline quality of life in the Veterans on ICDs.
Lasso di tempo: Quality of life questionnaires at 3, 6 and 12 mos follow ups
|
Quality of life questionnaires at 3, 6 and 12 mos follow ups
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Heather L Bloom, MD, FACC, Emory University IRB
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB00009530
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .