NCT01252615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

6.3 years

First QC Date

November 18, 2010

Last Update Submit

October 24, 2016

Conditions

Implantable Cardioverter Defibrillator (ICD)

Keywords

ICDHFcardiac arrestVFcardiac arrhythmias

Outcome Measures

Primary Outcomes (1)

  • Physical functioning

    symptoms, health related quality of life, steps/day

    3 months

Secondary Outcomes (1)

  • psychological adjustment

    3 months

Study Arms (2)

patient only

EXPERIMENTAL

Patient with the ICD is involved in the intervention

Behavioral: patient only

patient and partner

EXPERIMENTAL

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

Behavioral: patient and partner intervention

Interventions

patient onlyBEHAVIORAL

education, behavioral strategies, psychological interventions

patient only
patient and partner interventionBEHAVIORAL

education, psychological support, behavioral strategies

patient and partner

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cynthia M. Dougherty

Seattle, Washington, 98195, United States

Location

Related Publications (4)

  • 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.

    PMID: 34302228DERIVED

  • 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.

    PMID: 30340060DERIVED

  • 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.

    PMID: 26940383DERIVED

  • 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.

    PMID: 23107992DERIVED

MeSH Terms

Conditions

Heart ArrestArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cynthia M Dougherty, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Biobehavioral Nursing and Health Systems

Study Record Dates

First Submitted

November 18, 2010

First Posted

December 3, 2010

Study Start

July 1, 2009

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

US(1)