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

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ClinicalTrials.gov Identifier: NCT01252615
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Cynthia M. Dougherty, University of Washington

Brief Summary:
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 or disease Intervention/treatment Phase
Implantable Cardioverter Defibrillator (ICD) Behavioral: patient only Behavioral: patient and partner intervention Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252615


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cynthia M. Dougherty, Professor, Biobehavioral Nursing and Health Systems, University of Washington
ClinicalTrials.gov Identifier: NCT01252615     History of Changes
Other Study ID Numbers: 36576-C
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Cynthia M. Dougherty, University of Washington:
ICD
HF
cardiac arrest
VF
cardiac arrhythmias