NCT01252615

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

Patient and Intimate Partner Intervention to Improve Outcomes After an ICD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Implantable Cardioverter Defibrillator (ICD)

Interventions

Type	Name	Description
BEHAVIORAL	patient only	education, behavioral strategies, psychological interventions
BEHAVIORAL	patient and partner intervention	education, psychological support, behavioral strategies

Timeline

• Start date: 2009-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2010-12-03
• Last updated: 2016-10-26

Locations

1 site across 1 country: United States