An interventional study of Psychoeducational Telephone counseling (TC) and Psychoeducational Intervention by Group (SG) in Heart Failure and Ventricular Arrhythmias, sponsored by Emory University. Completed at 5 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-09-10.
Sponsored by Emory University · Not applicable, Interventional, and Supportive care
The overall purpose of this study is to test the effects of a nurse managed psychoeducational intervention, consisting of symptom management training (SMT) and cognitive-behavioral intervention (CBI), during the first year after ICD implantation using a 3 group randomized clinical trial.
Symptom distress and persistent physical and psychological changes characterize early and ongoing recovery from ventricular dysrhythmia and treatment with an implantable cardiac defibrillator (ICD). This study will test the effect of a psycho educational intervention on psychological and physical outcomes in the first 12 months after ICD implantation. Primary outcome measures are anxiety, depression, and functional status. The effect of the intervention on variables that mediate adaptation and outcomes (symptoms, illness appraisal, and coping behaviors) will also be examined. Secondary aims will examine subsequent arrhythmia events (ICD delivered therapy) and health resource utilization in relation to the main outcomes. The intervention and study variables are based on stress and coping theory and previous research with ICD patients, which documented negative outcomes of ineffective coping and compelling relationships between increased emotional distress and subsequent arrhythmia events.
A three-group, randomized, clinical trial with a repeated-measures design will be used. ICD patients (n=240) will be randomized to receive either the usual standard of care, symptom management training plus cognitive behavioral intervention delivered in a group format, or symptom management training plus cognitive behavioral intervention delivered by nurse provided telephone counseling. The symptom management-training component will be provided in the acute care setting and will focus on symptoms of pain, sleep disturbances and ICD shocks. The four cognitive behavioral sessions by group or telephone format will begin 6-8 weeks after hospitalization and will focus on illness reappraisal and coping skill training. Thus the intervention is designed to bridge the acute and outpatient continuum of care. A booster intervention will be provided at 4 months after implantation. Timeframes for evaluations are baseline, 1, 3, 6, and 12 months after implantation. This study will test whether a cost-effective, accessible, theoretically based, nurse-managed, psycho educational intervention provides an incremental effect over usual care in improving psychological and physical outcomes in ICD patients. This study will provide data upon which future clinical practice guidelines can be based and will establish priorities for patient care according to which interventions are linked to improved adaptive processes and patient outcomes. Greater understanding of the relationships among psychological and physical outcomes, arrhythmia events, and health resource utilization are important for future studies and evaluation of clinical practice with ICD patients.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 246 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Usual Care provided by providers
Behavioral: Usual Care
Education and Counseling for ICD patients provided through Telephone Contact
Behavioral: Psychoeducational Telephone counseling (TC)
Education and Counseling for ICD patients provided in a group setting with other ICD Patients
Behavioral: Psychoeducational Intervention by Group (SG)
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions
Also known as: TC
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions
Also known as: SG
Usual Care provided by providers
Also known as: UC
Anxiety
State-Trait Anxiety Inventory (STAI)
Time frame: 3, 6, 12 months
Depression
Beck Depression Inventory II
Time frame: 3, 6, 12 months
Functional status
Duke Activity Status Index
Time frame: 3, 6, 12 months
Subsequent arrhythmia events documented by ICD therapy
Arrhythmia events log
Time frame: 3, 6, 12 months
Patterns of health resource utilization (re-hospitalization, scheduled and unscheduled outpatient visits and contacts, disability days)
Health Resource Use Questionnaire (HRUQ)
Time frame: 3, 6, 12 months
Coping
Jalowiec Coping Scale
Time frame: 3, 6 12 months
Symptoms
Brief Pain Inventory and Pittsburgh Sleep Quality Inventory
Time frame: 3,6, 12 months
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Emory University