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Patient and Partner Intervention After an Implantable Cardioverter Defibrillator (ICD) (P+P)

This study is currently recruiting participants.
Verified September 2012 by University of Washington
Sponsor:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01252615
First received: November 18, 2010
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

The goal of this study is to compare a patient only to a patient+partner intervention on recovery outcomes of patients and partners after Implantable Cardioverter Defibrillator (ICD) implantation.


Condition Intervention Phase
Implantable Cardioverter Defibrillator (ICD)
 Behavioral: patient only
Behavioral: patient and partner intervention
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient and Intimate Partner Intervention to Improve Outcomes After an ICD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Physical functioning [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    symptoms, health related quality of life, steps/day


Secondary Outcome Measures:
  • psychological adjustment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    anxiety, depression, ICD acceptance


Estimated Enrollment: 300
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patient only
Patient with the ICD is involved in the intervention
 Behavioral: patient only
education, behavioral strategies, psychological interventions
Experimental: patient and partner
patient with the ICD and intimate partner are involved in the intervention
 Behavioral: patient and partner intervention
education, psychological support, behavioral strategies

Detailed Description:

The goal of this randomized trial is to test a patient+partner intervention against the patient only intervention on recovery outcomes of patients and partners after ICD implantation. By interventing with both ICD patients and their partners, we expect to further improve outcomes of patients and aid in recovery of partners. Over a five year period we will test the effects of a 12 week patient+partner intervention against a patient only intervention in the first year subsequent to ICD implantation, using a 2 group (N=150/group) randomized clinical trial design. Relevant data will be collected on ICD patients and intimate partners at hospital discharge, 1, 3, 6, 12 months post-ICD implantation. The four major outcomes are: physical functioning, psychological adjustment, health care utilization, and relationship impact. The primary analysis of treatment effect is the change in outcome variables from baseline to 3 months for the patient and partner. Secondarily, exploring long term effects of the intervention, theoretical elements, and the intervention effects by ICD implant reason will be determined.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first ICD implantation due to either primary or secondary prevention of SCA
  • intimate partner (spouse, lover, or life partner) living at the same residence and willing to participate
  • able to read, speak, and write English
  • access to telephone for 1 year after ICD implantation

Exclusion Criteria:

  • clinical co-morbidities that severely impair cognitive and physical functioning at telephone screening
  • Short BLESSED score > 6
  • age less than 21 years
  • AUDIT-C score > 4 for alcohol use
  • ASSIST 2.0 score > 4 for daily non-medical use of opiates or hallucinogens,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252615

Contacts
Contact: Cynthia M Dougherty, PHD 206-221-7927 cindyd@uw.edu

Locations
United States, Washington
Cynthia M. Dougherty Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Cynthia M Dougherty, PhD.            
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Cynthia M Dougherty, PhD University of Washington
  More Information

Additional Information:
web link to study information  This link exits the ClinicalTrials.gov site

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01252615     History of Changes
Other Study ID Numbers: 36576-C
Study First Received: November 18, 2010
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
ICD
HF
cardiac arrest
VF
cardiac arrhythmias

ClinicalTrials.gov processed this record on June 18, 2013