This trial is active, not recruiting.

Condition implantable cardioverter defibrillator (icd)
Treatments patient only, patient and partner intervention
Phase phase 2
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Patient with the ICD is involved in the intervention
patient only
education, behavioral strategies, psychological interventions
patient with the ICD and intimate partner are involved in the intervention
patient and partner intervention
education, psychological support, behavioral strategies

Primary Outcomes

Physical functioning
time frame: 3 months

Secondary Outcomes

psychological adjustment
time frame: 3 months

Eligibility Criteria

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,

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by University of Washington.