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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454817
• Other study ID #: HSM 10-00041
• Status: Completed
• Phase: N/A
• First received: October 14, 2011
• Last updated: October 7, 2016
• Start date: June 2012
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• ICDs
• Implantable Cardiac Defibrillators
• Quality of Life

Intervention

Behavioral:
• Quality of life
Improving Quality of Life

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University of Colorado - Denver	Denver	Colorado
United States	Yale New-Haven Hospital	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Medical Center	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Symptoms	physical symptoms of pain, shortness of breath, depression, anxiety	every 3 months plus after hospitalizations for an average of 1 year	No
Primary	Psychological Symptoms	Psychological symptoms of anxiety and depression	every 3 months plus after hospitalizations for an average of 1 year	No
Secondary	Quality of Life		every 3 months plus after hospitalizations for an average of 1 year	No