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

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ClinicalTrials.gov Identifier: NCT01454817
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : October 10, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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

Condition or disease Intervention/treatment Phase
Quality of Life Implantable Cardiac Defibrillators ICDs Behavioral: Quality of life Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 562 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Study of Symptoms and Quality of Life in Patients With ICDs and Their Caregivers
Study Start Date : June 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers
U.S. FDA Resources

Arm Intervention/treatment
Patients with ICDs Behavioral: Quality of life
Improving Quality of Life
Caregivers of Patients with ICDs Behavioral: Quality of life
Improving Quality of Life



Primary Outcome Measures :
  1. Physical Symptoms [ Time Frame: every 3 months plus after hospitalizations for an average of 1 year ]
    physical symptoms of pain, shortness of breath, depression, anxiety

  2. Psychological Symptoms [ Time Frame: every 3 months plus after hospitalizations for an average of 1 year ]
    Psychological symptoms of anxiety and depression


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: every 3 months plus after hospitalizations for an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454817


Locations
United States, Colorado
University of Colorado - Denver
Denver, Colorado, United States, 80045
United States, Connecticut
Yale New-Haven Hospital
New Haven, Connecticut, United States, 06510
United States, Minnesota
Mayo Medical Center
Rochester, Minnesota, United States, 55905
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10023
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Nathan Goldstein, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01454817     History of Changes
Other Study ID Numbers: HSM 10-00041
First Posted: October 19, 2011    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016

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