A Study of Symptoms and Quality of Life in Patients With Implantable Cardiac Defibrillators (ICDs) and Their Caregivers
Not Applicable
Completed
- Conditions
- ICDsImplantable Cardiac DefibrillatorsQuality of Life
- Interventions
- Behavioral: Quality of life
- Registration Number
- NCT01454817
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 562
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with ICDs Quality of life - Caregivers of Patients with ICDs Quality of life -
- Primary Outcome Measures
Name Time Method Psychological Symptoms every 3 months plus after hospitalizations for an average of 1 year Psychological symptoms of anxiety and depression
Physical Symptoms every 3 months plus after hospitalizations for an average of 1 year physical symptoms of pain, shortness of breath, depression, anxiety
- Secondary Outcome Measures
Name Time Method Quality of Life every 3 months plus after hospitalizations for an average of 1 year
Trial Locations
- Locations (6)
Mayo Medical Center
🇺🇸Rochester, Minnesota, United States
Yale New-Haven Hospital
🇺🇸New Haven, Connecticut, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Colorado - Denver
🇺🇸Denver, Colorado, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States