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

University of Washington

Status and phase: Completed; Phase 2

Conditions: Implantable Cardioverter Defibrillator (ICD)

Treatments: Behavioral: patient only; Behavioral: patient and partner intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01252615

36576-C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 301 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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301 participants in 2 patient groups

patient only

Experimental group

Description:

Patient with the ICD is involved in the intervention

Treatment:

Behavioral: patient only

patient and partner

Experimental group

Description:

patient with the ICD and intimate partner are involved in the intervention

Treatment:

Behavioral: patient and partner intervention