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

NCT ID: NCT01252615

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Implantable Cardioverter Defibrillator (ICD)

Keywords

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ICD HF cardiac arrest VF cardiac arrhythmias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patient only

Patient with the ICD is involved in the intervention

Group Type EXPERIMENTAL

patient only

Intervention Type BEHAVIORAL

education, behavioral strategies, psychological interventions

patient and partner

patient with the ICD and intimate partner are involved in the intervention

Group Type EXPERIMENTAL

patient and partner intervention

Intervention Type BEHAVIORAL

education, psychological support, behavioral strategies

Interventions

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patient only

education, behavioral strategies, psychological interventions

Intervention Type BEHAVIORAL

patient and partner intervention

education, psychological support, behavioral strategies

Intervention Type BEHAVIORAL

Eligibility Criteria

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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,
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Cynthia M. Dougherty

Professor, Biobehavioral Nursing and Health Systems

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia M Dougherty, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Cynthia M. Dougherty

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34302228 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30340060 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26940383 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23107992 (View on PubMed)

Other Identifiers

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36576-C

Identifier Type: -

Identifier Source: org_study_id