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

Phase 2

Completed

• Conditions: Implantable Cardioverter Defibrillator (ICD)
• Interventions: Behavioral: patient only; Behavioral: patient and partner intervention

• Registration Number: NCT01252615
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-30
• Study First Posted: 2010-12-03
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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

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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,

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient only	patient only	Patient with the ICD is involved in the intervention
patient and partner	patient and partner intervention	patient with the ICD and intimate partner are involved in the intervention

Primary Outcome Measures

Name	Time	Method
Physical functioning	3 months	symptoms, health related quality of life, steps/day

Secondary Outcome Measures

Name	Time	Method
psychological adjustment	3 months	anxiety, depression, ICD acceptance

Trial Locations

Locations (1)

Cynthia M. Dougherty; 🇺🇸 Seattle, Washington, United States