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

October 7, 2016 updated by: Icahn School of Medicine at Mount Sinai

A Study of Symptoms and Quality of Life in Patients With ICDs and Their Caregivers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

562

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado - Denver
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New-Haven Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Medical Center
    • New York
      • Bronx, New York, United States, 10023
        • Montefiore Medical Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with ICDs
Behavioral: Quality of life
Improving Quality of Life
Other: Caregivers of Patients with ICDs
Behavioral: Quality of life
Improving Quality of Life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every 3 months plus after hospitalizations for an average of 1 year
Psychological Symptoms
Time Frame: every 3 months plus after hospitalizations for an average of 1 year
Psychological symptoms of anxiety and depression
every 3 months plus after hospitalizations for an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: every 3 months plus after hospitalizations for an average of 1 year
every 3 months plus after hospitalizations for an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Nathan Goldstein, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 14, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSM 10-00041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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