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

• ClinicalTrials.gov Identifier: NCT01252615
• Recruitment Status: Completed
• First Posted: December 3, 2010
• Last Update Posted: October 26, 2016
• Sponsor: University of Washington
• Information provided by (Responsible Party): Cynthia M. Dougherty, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Implantable Cardioverter Defibrillator (ICD)	Behavioral: patient only; Behavioral: patient and partner intervention	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 301 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Patient and Intimate Partner Intervention to Improve Outcomes After an ICD
• Study Start Date: July 2009
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: patient only; Patient with the ICD is involved in the intervention	Behavioral: patient only; education, behavioral strategies, psychological interventions
Experimental: patient and partner; patient with the ICD and intimate partner are involved in the intervention	Behavioral: patient and partner intervention; education, psychological support, behavioral strategies

Outcome Measures

Primary Outcome Measures :

1. Physical functioning [ Time Frame: 3 months ]
   symptoms, health related quality of life, steps/day

Secondary Outcome Measures :

1. psychological adjustment [ Time Frame: 3 months ]
   anxiety, depression, ICD acceptance

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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,

Contacts and Locations

Locations

United States, Washington

Cynthia M. Dougherty

Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

Investigators

• Principal Investigator: Cynthia M Dougherty, PhD; University of Washington

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

• Responsible Party: Cynthia M. Dougherty, Professor, Biobehavioral Nursing and Health Systems, University of Washington
• ClinicalTrials.gov Identifier: NCT01252615
• Other Study ID Numbers: 36576-C
• First Posted: December 3, 2010
• Last Update Posted: October 26, 2016
• Last Verified: October 2016

Keywords provided by Cynthia M. Dougherty, University of Washington:

ICD; HF; cardiac arrest; VF; cardiac arrhythmias