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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Washington.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
University of Washington Identifier:
First received: November 18, 2010
Last updated: September 12, 2012
Last verified: September 2012

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:

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01252615

Contact: Cynthia M Dougherty, PHD 206-221-7927

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

Additional Information:
No publications provided by University of Washington

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Washington 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:
cardiac arrest
cardiac arrhythmias processed this record on October 21, 2014