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Clinical Trials/NCT01454817
NCT01454817
Completed
Not Applicable

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

Icahn School of Medicine at Mount Sinai6 sites in 1 country562 target enrollmentJune 2012
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ConditionsQuality of LifeImplantable Cardiac DefibrillatorsICDs

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
562
Locations
6
Primary Endpoint
Psychological Symptoms
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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

Outcomes

Primary Outcomes

Psychological Symptoms

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

Psychological symptoms of anxiety and depression

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

Secondary Outcomes

  • Quality of Life(every 3 months plus after hospitalizations for an average of 1 year)

Study Sites (6)

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