A Study of Symptoms and Quality of Life in Patients With Implantable Cardiac Defibrillators (ICDs) and Their Caregivers
1 other identifier
interventional
562
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable quality-of-life
Started Jun 2012
Longer than P75 for not_applicable quality-of-life
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 10, 2016
October 1, 2016
4.3 years
October 14, 2011
October 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Physical Symptoms
physical symptoms of pain, shortness of breath, depression, anxiety
every 3 months plus after hospitalizations for an average of 1 year
Psychological Symptoms
Psychological symptoms of anxiety and depression
every 3 months plus after hospitalizations for an average of 1 year
Secondary Outcomes (1)
Quality of Life
every 3 months plus after hospitalizations for an average of 1 year
Study Arms (2)
Patients with ICDs
OTHERCaregivers of Patients with ICDs
OTHERInterventions
Improving Quality of Life
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Not having an ICD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Colorado - Denver
Denver, Colorado, 80045, United States
Yale New-Haven Hospital
New Haven, Connecticut, 06510, United States
Mayo Medical Center
Rochester, Minnesota, 55905, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10023, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Goldstein, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2011
First Posted
October 19, 2011
Study Start
June 1, 2012
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 10, 2016
Record last verified: 2016-10