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

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT01454817
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 562
• Locations: 6
• Arms: 2
• Duration (Months): 51
• Patients Per Site: 93.7
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Quality of Life; Implantable Cardiac Defibrillators; ICDs	Behavioral: Quality of life	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 562 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Study of Symptoms and Quality of Life in Patients With ICDs and Their Caregivers
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with ICDs	Behavioral: Quality of life; Improving Quality of Life
Other: Caregivers of Patients with ICDs	Behavioral: Quality of life; Improving Quality of Life

Outcome Measures

Primary Outcome Measures

1. Physical Symptoms [every 3 months plus after hospitalizations for an average of 1 year]

   physical symptoms of pain, shortness of breath, depression, anxiety

2. Psychological Symptoms [every 3 months plus after hospitalizations for an average of 1 year]

   Psychological symptoms of anxiety and depression

Secondary Outcome Measures

1. Quality of Life [every 3 months plus after hospitalizations for an average of 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado - Denver	Denver	Colorado	United States	80045
2	Yale New-Haven Hospital	New Haven	Connecticut	United States	06510
3	Mayo Medical Center	Rochester	Minnesota	United States	55905
4	Montefiore Medical Center	Bronx	New York	United States	10023
5	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
6	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Nathan Goldstein, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01454817
• Other Study ID Numbers: HSM 10-00041
• First Posted: Oct 19, 2011
• Last Update Posted: Oct 10, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Icahn School of Medicine at Mount Sinai: Quality of Life; Implantable Cardiac Defibrillators; ICDs

Study Results

No Results Posted as of Oct 10, 2016