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

This study has been completed.
Information provided by (Responsible Party):
Cynthia M. Dougherty, University of Washington Identifier:
First received: November 18, 2010
Last updated: October 24, 2016
Last verified: October 2016
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
Intervention Model: Parallel Assignment
Masking: None (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 Cynthia M. Dougherty, University of Washington:

Primary Outcome Measures:
  • Physical functioning [ Time Frame: 3 months ]
    symptoms, health related quality of life, steps/day

Secondary Outcome Measures:
  • psychological adjustment [ Time Frame: 3 months ]
    anxiety, depression, ICD acceptance

Enrollment: 301
Study Start Date: July 2009
Study Completion Date: October 2015
Primary Completion Date: October 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT01252615

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cynthia M. Dougherty, Professor, Biobehavioral Nursing and Health Systems, University of Washington Identifier: NCT01252615     History of Changes
Other Study ID Numbers: 36576-C
Study First Received: November 18, 2010
Last Updated: October 24, 2016

Keywords provided by Cynthia M. Dougherty, University of Washington:
cardiac arrest
cardiac arrhythmias processed this record on September 21, 2017