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

Mount Sinai Health System

Status: Completed

Conditions: Quality of Life; Implantable Cardiac Defibrillators; ICDs

Treatments: Behavioral: Quality of life

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01454817

HSM 10-00041

Details and patient eligibility

About

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

Enrollment: 562 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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562 participants in 2 patient groups

Patients with ICDs

Other group

Treatment:

Behavioral: Quality of life

Caregivers of Patients with ICDs

Other group

Treatment:

Behavioral: Quality of life