AzTrials
AzTrials

Heart FailureNCT00146679

Psychoeducational Intervention for ICD Patients (PEACE)

A study testing Psychoeducational Telephone counseling (TC) and Psychoeducational Intervention by Group (SG) in people with Heart Failure and Ventricular Arrhythmias, run by Emory University at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Heart Failure, Ventricular Arrhythmias
What is being tested?
Psychoeducational Telephone counseling (TC) and Psychoeducational Intervention by Group (SG)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
246 participants
Where
5 sitesUnited States
Study dates
Mar 2001to Feb 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All subjects must have a nonthoracotomy insertion
  • Have a primary cardiac etiology of their ventricular arrhythmia (coronary artery disease, cardiomyopathy, valve dysfunction, or combination)
  • Be fluent in English
  • Live within a 75 mile radius of the coordinating center
  • Be accessible by telephone
  • Only those receiving their first ICD, not replacement generators, will be entered.

Who cannot join

  • Being evaluated or on a waiting list for heart transplantation
  • Congenital disease or long QT syndrome
  • Disorientation documented in the pre-implantation hospitalization period
  • History of psychiatric disorder or progressively debilitating comorbidity that would confound outcome measures

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Crawford Long Hospital

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • St. Joseph's Hospital

    Atlanta, Georgia, 30342

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Psychoeducational Telephone counseling (TC), Psychoeducational Intervention by Group (SG), Usual Care
Keywords
Heart failure, Ventricular arrhythmias, ICD, Psychoeducational intervention
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychoeducational Telephone counseling (TC)Behavioural

    Also called TC

    Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions

  • Psychoeducational Intervention by Group (SG)Behavioural

    Also called SG

    Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions

  • Usual CareBehavioural

    Also called UC

    Usual Care provided by providers

Study groups in NCT00146679
Study groupRoleWhat they receive
Usual Care (UC)Placebo comparatorUsual Care provided by providers
Receives: Behavioral: Usual Care
Psychoeducational Telephone CounselingTCActive comparatorEducation and Counseling for ICD patients provided through Telephone Contact
Receives: Behavioral: Psychoeducational Telephone counseling (TC)
Psychoeducation through Groups (SG)Active comparatorEducation and Counseling for ICD patients provided in a group setting with other ICD Patients
Receives: Behavioral: Psychoeducational Intervention by Group (SG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety

    State-Trait Anxiety Inventory (STAI)

    Measured: 3, 6, 12 months

  2. Depression

    Beck Depression Inventory II

    Measured: 3, 6, 12 months

  3. Functional status

    Duke Activity Status Index

    Measured: 3, 6, 12 months

Secondary outcomes (4)

  1. Subsequent arrhythmia events documented by ICD therapy

    Arrhythmia events log

    Measured: 3, 6, 12 months

  2. Patterns of health resource utilization (re-hospitalization, scheduled and unscheduled outpatient visits and contacts, disability days)

    Health Resource Use Questionnaire (HRUQ)

    Measured: 3, 6, 12 months

  3. Coping

    Jalowiec Coping Scale

    Measured: 3, 6 12 months

  4. Symptoms

    Brief Pain Inventory and Pittsburgh Sleep Quality Inventory

    Measured: 3,6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startMar 2001
  3. Primary completionJun 2005
  4. Study completionFeb 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00146679
Sponsor's protocol ID
0430-1999
Other IDs
SR01 NR 5187-03
Status last verified
Sep 2013
First submitted
2 Sep 2005
Last updated
10 Sep 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Dunbar SB. Psychosocial issues of patients with implantable cardioverter defibrillators. Am J Crit Care. 2005 Jul;14(4):294-303.

    PubMed 15980420

  • O'Brien MC, Langberg J, Valderrama AL, Kirkendoll K, Romeiko N, Dunbar SB. Implantable cardioverter defibrillator storm: nursing care issues for patients and families. Crit Care Nurs Clin North Am. 2005 Mar;17(1):9-16, ix. doi: 10.1016/j.ccell.2004.09.002.

    PubMed 15749396

  • Dunbar SB, Funk M, Wood K, Valderrama AL. Ventricular dysrhythmias: nursing approaches to health outcomes. J Cardiovasc Nurs. 2004 Sep-Oct;19(5):316-28. doi: 10.1097/00005082-200409000-00007.

    PubMed 15495892

  • Berg SK, Higgins M, Reilly CM, Langberg JJ, Dunbar SB. Sleep quality and sleepiness in persons with implantable cardioverter defibrillators: outcome from a clinical randomized longitudinal trial. Pacing Clin Electrophysiol. 2012 Apr;35(4):431-43. doi: 10.1111/j.1540-8159.2011.03328.x. Epub 2012 Feb 3.

    PubMed 22303998

  • Dunbar SB, Langberg JJ, Reilly CM, Viswanathan B, McCarty F, Culler SD, O'Brien MC, Weintraub WS. Effect of a psychoeducational intervention on depression, anxiety, and health resource use in implantable cardioverter defibrillator patients. Pacing Clin Electrophysiol. 2009 Oct;32(10):1259-71. doi: 10.1111/j.1540-8159.2009.02495.x.

    PubMed 19796343

  • Smith G, Dunbar SB, Valderrama AL, Viswanathan B. Gender differences in implantable cardioverter-defibrillator patients at the time of insertion. Prog Cardiovasc Nurs. 2006 Spring;21(2):76-82. doi: 10.1111/j.0889-7204.2006.04843.x.

    PubMed 16760689

Questions about this trial

What is this clinical trial studying?

A study testing Psychoeducational Telephone counseling (TC) and Psychoeducational Intervention by Group (SG) in people with Heart Failure and Ventricular Arrhythmias, run by Emory University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety (time frame: 3, 6, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00146679, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in