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A Study of Symptoms and Quality of Life in Patients With Implantable Cardiac Defibrillators (ICDs) and Their Caregivers

This study is currently recruiting participants.
Verified May 2012 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01454817
First received: October 14, 2011
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to better understand symptoms and quality of life in patients with heart disease and implantable defibrillators (ICDs).


Condition Intervention
Quality of Life
Implantable Cardiac Defibrillators
ICDs
 Behavioral: Quality of life

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Study of Symptoms and Quality of Life in Patients With ICDs and Their Caregivers

Resource links provided by NLM:

MedlinePlus related topics: Caregivers
U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Physical Symptoms [ Time Frame: every 3 months plus after hospitalizations for an average of 1 year ] [ Designated as safety issue: No ]
    physical symptoms of pain, shortness of breath, depression, anxiety

  • Psychological Symptoms [ Time Frame: every 3 months plus after hospitalizations for an average of 1 year ] [ Designated as safety issue: No ]
    Psychological symptoms of anxiety and depression


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: every 3 months plus after hospitalizations for an average of 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: September 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patients with ICDs Behavioral: Quality of life
Improving Quality of Life
Caregivers of Patients with ICDs Behavioral: Quality of life
Improving Quality of Life

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients:

  • Patient has an ICD
  • Age > 18
  • Fluent in English
  • Consistent and reliable access to a phone.

Caregivers of Patients:

  • Age > 18
  • Fluent in English
  • Consistent and reliable access to a phone

Exclusion Criteria:

  • Not having an ICD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454817

Contacts
Contact: Nathan Goldstein, MD 212-241-1446 Nathan.Goldstein@mssm.edu
Contact: Omarys I. Herasme, MPH 212-241-0163 Omarys.Herasme@mssm.edu

Locations
United States, Colorado
University of Colorado - Denver Recruiting
Denver, Colorado, United States, 80045
United States, Minnesota
Mayo Medical Center Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10023
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Principal Investigator: Nathan Goldstein, MD            
Sub-Investigator: R. Sean Morrison, MD            
Sub-Investigator: Jill Kalman, MD            
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Mount Sinai School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Nathan Goldstein, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01454817     History of Changes
Other Study ID Numbers: HSM 10-00041
Study First Received: October 14, 2011
Last Updated: May 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Quality of Life
Implantable Cardiac Defibrillators
ICDs

ClinicalTrials.gov processed this record on May 19, 2013