Implantable Cardioverter Defibrillator (ICD)
Conditions
Keywords
ICD, HF, cardiac arrest, VF, cardiac arrhythmias
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.
Interventions
BEHAVIORALpatient only
education, behavioral strategies, psychological interventions
BEHAVIORALpatient and partner intervention
education, psychological support, behavioral strategies
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical functioning | 3 months | symptoms, health related quality of life, steps/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| psychological adjustment | 3 months | anxiety, depression, ICD acceptance |
Countries
United States
Outcome results
None listed