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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient and Intimate Partner Intervention to Improve Outcomes After an ICD

Conditions
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Implantable Cardioverter Defibrillator (ICD)

Intervention / Treatment
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* Behavioral: patient only
* Behavioral: patient and partner intervention


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient only<br>Patient with the ICD is involved in the intervention | Behavioral: patient only<br>* education, behavioral strategies, psychological interventions<br>|
| Experimental: patient and partner<br>patient with the ICD and intimate partner are involved in the intervention | Behavioral: patient and partner intervention<br>* education, psychological support, behavioral strategies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functioning | symptoms, health related quality of life, steps/day | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychological adjustment | anxiety, depression, ICD acceptance | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, HF, cardiac arrest, VF, cardiac arrhythmias