Patient and Partner Intervention After an Implantable Cardioverter Defibrillator (ICD)
This trial is active, not recruiting.
|Condition||implantable cardioverter defibrillator (icd)|
|Treatments||patient only, patient and partner intervention|
|Sponsor||University of Washington|
|Start date||July 2009|
|End date||October 2015|
|Trial size||301 participants|
|Trial identifier||NCT01252615, 36576-C|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: 3 months
time frame: 3 months
Male or female participants at least 21 years old.
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,
|Official title||Patient and Intimate Partner Intervention to Improve Outcomes After an ICD|
|Principal investigator||Cynthia M Dougherty, PhD|
|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.|
Call for more information