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Implantable Cardioverter Defibrillator (ICD) Support Groups and Veterans

10. september 2013 opdateret af: Heather Bloom, Emory University

Impact of ICD Support Groups in Veterans Receiving Internal Cardioverter Defibrillators

In this study, we will compare the quality of life in veterans having ICD who attend the ICD support groups to those who do not. We ask them to answer a set of quality of life questionnaires at baseline and then at 3,6,9 and 12 month visits. These questionnaires would be analyzed to assess if attending support groups made a difference. These results will be compared to a similar study done at Emory University on non veterans.

Studieoversigt

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients of primary care cardiology clinics at the Atlanta VAMC

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Case
Patients with ICDs who attend the ICD Support Groups.
Control
Patients with ICDs who do not attend the ICD support groups.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: Documented nine months after the time of enrollment.
Documented nine months after the time of enrollment.

Sekundære resultatmål

Resultatmål
Tidsramme
This study is observational. It entails questionnaires after enrollment regarding assessing the baseline quality of life in the Veterans on ICDs.
Tidsramme: Quality of life questionnaires at 3, 6 and 12 mos follow ups
Quality of life questionnaires at 3, 6 and 12 mos follow ups

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Heather L Bloom, MD, FACC, Emory University IRB

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2008

Primær færdiggørelse (Faktiske)

1. juni 2010

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

16. februar 2009

Først indsendt, der opfyldte QC-kriterier

17. februar 2009

Først opslået (Skøn)

18. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2013

Sidst verificeret

1. september 2013

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ventrikulær fibrillation

3
Abonner