Clinical trial NCT01252615: Patient and Partner Intervention After an Implantable Cardioverter Defibrillator (ICD)
Official title: Patient and Intimate Partner Intervention to Improve Outcomes After an ICD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Implantable Cardioverter Defibrillator (ICD)
Keywords: ICD
HF
cardiac arrest
VF
cardiac arrhythmias
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 301
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Physical functioning
timeFrame: 3 months
Secondary outcomes:
measure: psychological adjustment
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Cynthia M. Dougherty
state: Washington
Study officials:
affiliation: University of Washington
name: Cynthia M Dougherty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liberato ACS, Thompson EA, Dougherty CM. Intervention mediating effects of self-efficacy on patient physical and psychological health following ICD implantation. J Behav Med. 2021 Dec;44(6):842-852. doi: 10.1007/s10865-021-00244-8. Epub 2021 Jul 23.
citation: Dougherty CM, Thompson EA, Kudenchuk PJ. Patient plus partner trial: A randomized controlled trial of 2 interventions to improve outcomes after an initial implantable cardioverter-defibrillator. Heart Rhythm. 2019 Mar;16(3):453-459. doi: 10.1016/j.hrthm.2018.10.011. Epub 2018 Oct 16.
citation: Lau ET, Thompson EA, Burr RL, Dougherty CM. Safety and Efficacy of an Early Home-Based Walking Program After Receipt of an Initial Implantable Cardioverter-Defibrillator. Arch Phys Med Rehabil. 2016 Aug;97(8):1228-36. doi: 10.1016/j.apmr.2016.02.007. Epub 2016 Mar 3.
citation: Dougherty CM, Thompson EA, Kudenchuk PJ. Development and testing of an intervention to improve outcomes for partners following receipt of an implantable cardioverter defibrillator in the patient. ANS Adv Nurs Sci. 2012 Oct-Dec;35(4):359-77. doi: 10.1097/ANS.0b013e318271d2e8.