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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01454817

Enrollment

562

Registered

2011-10-19

Start date

2012-06-30

Completion date

2016-09-30

Last updated

2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICDs, Implantable Cardiac Defibrillators, Quality of Life

Keywords

Quality of Life, Implantable Cardiac Defibrillators, ICDs

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).

Interventions

BEHAVIORALQuality of life

Improving Quality of Life

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Physical Symptoms	every 3 months plus after hospitalizations for an average of 1 year	physical symptoms of pain, shortness of breath, depression, anxiety
Psychological Symptoms	every 3 months plus after hospitalizations for an average of 1 year	Psychological symptoms of anxiety and depression

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026