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

NCT ID: NCT01454817

Last Updated: 2016-10-10

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

NA

Total Enrollment

562 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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Conditions

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Quality of Life Implantable Cardiac Defibrillators ICDs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Patients with ICDs

Group Type OTHER

Quality of life

Intervention Type BEHAVIORAL

Improving Quality of Life

Caregivers of Patients with ICDs

Group Type OTHER

Quality of life

Intervention Type BEHAVIORAL

Improving Quality of Life

Interventions

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Quality of life

Improving Quality of Life

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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University of Colorado - Denver

Denver, Colorado, United States

Site Status

Yale New-Haven Hospital

New Haven, Connecticut, United States

Site Status

Mayo Medical Center

Rochester, Minnesota, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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HSM 10-00041

Identifier Type: -

Identifier Source: org_study_id

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