Quality of LifeNCT01454817
A Study of Symptoms and Quality of Life in Patients With Implantable Cardiac Defibrillators (ICDs) and Their Caregivers
A study testing Quality of life in people with Quality of Life and Implantable Cardiac Defibrillators, run by Icahn School of Medicine at Mount Sinai at 6 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Implantable Cardiac Defibrillators, ICDs
- What is being tested?
- Quality of life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2012to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- Patient has an ICD
- Age > 18
- Fluent in English
- Consistent and reliable access to a phone.
- Caregivers of Patients:
Show all 9Show fewer
- Age > 18
- Fluent in English
- Consistent and reliable access to a phone
Who cannot join
- Not having an ICD
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado - Denver
Denver, Colorado, 80045
Yale New-Haven Hospital
New Haven, Connecticut, 06510
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Medical Center
Rochester, Minnesota, 55905
Montefiore Medical Center
The Bronx, New York, 10023
About this study
Official title: A Study of Symptoms and Quality of Life in Patients With ICDs and Their Caregivers
The purpose of this study is to better understand symptoms and quality of life in patients with heart disease and implantable defibrillators (ICDs).
- Conditions
- Quality of Life, Implantable Cardiac Defibrillators, ICDs
- Being tested
- Quality of life
- Keywords
- Quality of Life, Implantable Cardiac Defibrillators, ICDs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of lifeBehavioural
Improving Quality of Life
| Study group | Role | What they receive |
|---|---|---|
| Patients with ICDs | Other | Not described Receives: Behavioral: Quality of life |
| Caregivers of Patients with ICDs | Other | Not described Receives: Behavioral: Quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Symptoms
physical symptoms of pain, shortness of breath, depression, anxiety
Measured: every 3 months plus after hospitalizations for an average of 1 year
Psychological Symptoms
Psychological symptoms of anxiety and depression
Measured: every 3 months plus after hospitalizations for an average of 1 year
Secondary outcomes (1)
Quality of Life
Measured: every 3 months plus after hospitalizations for an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJun 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nathan Goldstein, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454817
- Sponsor's protocol ID
- HSM 10-00041
- Status last verified
- Oct 2016
- First submitted
- 14 Oct 2011
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Symptoms and Quality of Life in Patients With ICDs and Their Caregivers
- ClinicalTrials.gov ID
- NCT01454817
- Acronym / sponsor ID
- HSM 10-00041
- Conditions
- Quality of Life, Implantable Cardiac Defibrillators, ICDs
- Keywords
- Quality of Life, Implantable Cardiac Defibrillators, ICDs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand symptoms and quality of life in patients with heart disease and implantable defibrillators (ICDs).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ICDs | Other | Behavioral: Quality of life |
| Caregivers of Patients with ICDs | Other | Behavioral: Quality of life |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient has an ICD
- Age > 18
- Fluent in English
- Consistent and reliable access to a phone.
- Age > 18
Key exclusion criteria (1 listed)
- Not having an ICD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of lifeImproving Quality of Life | Behavioural | Caregivers of Patients with ICDs, Patients with ICDs |
Primary outcome
Physical Symptoms
Time frame: every 3 months plus after hospitalizations for an average of 1 year
physical symptoms of pain, shortness of breath, depression, anxiety
Psychological Symptoms
Time frame: every 3 months plus after hospitalizations for an average of 1 year
Psychological symptoms of anxiety and depression
1 secondary outcome
Quality of Life
Time frame: every 3 months plus after hospitalizations for an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Goldstein, MD principal investigator
Icahn School of Medicine at Mount Sinai
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life in people with Quality of Life and Implantable Cardiac Defibrillators, run by Icahn School of Medicine at Mount Sinai at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Symptoms (time frame: every 3 months plus after hospitalizations for an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2016.