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OpenTrials
Completed

NCT Number: NCT01454817

A Study of Symptoms and Quality of Life in Patients With Implantable Cardiac Defibrillators (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).

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Key information

Conditions

Quality of Life ICDs Implantable Cardiac Defibrillators

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado - Denver, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quality of life

Behavioral

Improving Quality of Life

Primary outcomes

  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 outcomes

  1. Quality of Life

    Time frame: every 3 months plus after hospitalizations for an average of 1 year

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2011
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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