Cardiovascular DiseasesFIT-ONCT00990548
Family Cardiac Caregiver Investigation to Evaluate Outcomes
An observational study of Cardiovascular Diseases and Heart Diseases, run by Columbia University at 1 site in United States.
Trial summary
The purpose of the FIT-O study was to estimate the prevalence of having a caregiver (paid and/or informal) among hospitalized cardiac patients by demographic factors such as patient age and race/ethnicity, and to link caregiver status to clinical outcomes following hospitalization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- 4,500 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cardiovascular Service Line inpatients at Columbia University Medical Center/New York Presbyterian Hospital during a consecutive 11-month period.
Who may be able to join
- All inpatients admitted to the Cardiovascular Service Line at Columbia University Medical Center/New York-Presbyterian Hospital during a consecutive 11-month period will receive a survey as a routine part of hospital admission.
Who cannot join
- Inability to read or understand English or Spanish.
- Refusal to complete survey.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center/New York-Presbyterian Hosptial
New York, New York, 10032
About this study
Official title: Family Cardiac Caregiver Investigation to Evaluate Outcomes (FIT-O)
The purpose of the FIT-O study was to estimate the prevalence of having a caregiver (paid and/or informal) among hospitalized cardiac patients by demographic factors such as patient age and race/ethnicity, and to link caregiver status to clinical outcomes following hospitalization. A secondary aim was to collect anonymous family tree data to provide an estimate of the number of first degree family members, their basic demographics, and the distance at which they live from the medical center.
Read the detailed description
It has been established that cardiac caregivers are a vehicle by which health information can be transmitted, and that caregivers themselves may be at increased CVD risk. Our research evaluated the potential pool and demographic profile of cardiac caregivers as well as the role(s) they play in improving quality of patient care and to enhance adherence to secondary prevention guidelines post discharge. This research also provided important information about targeting educational efforts to specific caregivers to enhance the clinical outcomes of hospitalized coronary patients. The purpose of this study was to estimate the prevalence of caregiving in hospitalized cardiac patients by demographic factors such as patient age and race/ethnicity, and to link caregiving to clinical outcomes in cardiac patients. A secondary aim was to collect family tree data which would allow us to estimate the number of first degree family members, their basic demographics, and the distance at which they live from the medical center in order to determine the feasibility and scope of a targeted preventive intervention. The significance of this research is that it addressed specific challenges outlined in the recent NHLBI strategic plan to develop and evaluate programs to improve patient, provider, and health care system behavior and performance to enhance quality of care and health outcomes, especially in populations that experience a disproportionate disease burden. Unique information was obtained about caregivers as a potential intervention to improve preventive care and health outcomes of patients and families that suffer disproportionate CVD burden. Improved adherence to evidence-based preventive therapies could have a substantial public health benefit.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Keywords
- Cardiac Caregivers, Cardiac Patient Clinical Outcomes, Prevention of CVD
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular Service Line patients | Patients admitted to the Cardiovascular Service Line at a major teaching hospital during a consecutive 11-month period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence and demographic characteristics of cardiac caregivers among consecutively admitted patients with an acute atherosclerotic coronary event or surgical or catheter-based coronary revascularization procedure.
Cardiac caregivers were classified as either an unpaid family member or friend who assist the patient in complying with medical and lifestyle therapies post-discharge or as a paid professional caregiver. Standardized data were collected on the nature of the tasks the caregiver performs and the caregiver's relationship to the hospitalized patient.
Measured: Upon admission to a major academic teaching hospital
Secondary outcomes (1)
To determine the relation between having or not having a cardiac caregiver and patient clinical outcomes post hospital discharge adjusted for patient demographic characteristics, admitting diagnoses, and co-morbidities.
Measured: At admission and 1-year post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Lori Mosca, MD, MPH, PhD, Principal investigator, Columbia University Medical Center/New York-Presbyterian Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990548
- Sponsor's protocol ID
- AAAE1561
- Other IDs
- R01HL075101-05A1
- Acronym
- FIT-O
- Status last verified
- May 2024
- First submitted
- 6 Oct 2009
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Aggarwal B, Liao M, Mosca L. Medication adherence is associated with having a caregiver among cardiac patients. Ann Behav Med. 2013 Oct;46(2):237-42. doi: 10.1007/s12160-013-9492-8.
PubMed 23536121Mochari-Greenberger H, Mosca M, Aggarwal B, Umann TM, Mosca L. Caregiver status: a simple marker to identify cardiac surgery patients at risk for longer postoperative length of stay, rehospitalization, or death. J Cardiovasc Nurs. 2014 Jan-Feb;29(1):12-9. doi: 10.1097/JCN.0b013e318274d19b.
PubMed 23321779Hammond G, Mochari-Greenberger H, Liao M, Mosca L. Effect of gender, caregiver, on cholesterol control and statin use for secondary prevention among hospitalized patients with coronary heart disease. Am J Cardiol. 2012 Dec 1;110(11):1613-8. doi: 10.1016/j.amjcard.2012.07.028. Epub 2012 Aug 15.
PubMed 22901971Mosca L, Aggarwal B, Mochari-Greenberger H, Liao M, Blair J, Cheng B, Comellas M, Rehm L, Suero-Tejeda N, Umann T. Association between having a caregiver and clinical outcomes 1 year after hospitalization for cardiovascular disease. Am J Cardiol. 2012 Jan 1;109(1):135-9. doi: 10.1016/j.amjcard.2011.07.072. Epub 2011 Sep 29.
PubMed 21962999Mosca L, Mochari-Greenberger H, Aggarwal B, Liao M, Suero-Tejeda N, Comellas M, Rehm L, Umann TM, Mehran R. Patterns of caregiving among patients hospitalized with cardiovascular disease. J Cardiovasc Nurs. 2011 Jul-Aug;26(4):305-11. doi: 10.1097/JCN.0b013e3181f34bb3.
PubMed 21330929Villanueva C, Aggarwal B. The association between neighborhood socioeconomic status and clinical outcomes among patients 1 year after hospitalization for cardiovascular disease. J Community Health. 2013 Aug;38(4):690-7. doi: 10.1007/s10900-013-9666-0.
PubMed 23468321Blair J, Volpe M, Aggarwal B. Challenges, needs, and experiences of recently hospitalized cardiac patients and their informal caregivers. J Cardiovasc Nurs. 2014 Jan-Feb;29(1):29-37. doi: 10.1097/JCN.0b013e3182784123.
PubMed 23416934
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Cardiac Caregiver Investigation to Evaluate Outcomes (FIT-O)
- ClinicalTrials.gov ID
- NCT00990548
- Acronym / sponsor ID
- FIT-O / AAAE1561
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Keywords
- Cardiac Caregivers, Cardiac Patient Clinical Outcomes, Prevention of CVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,500 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Oct 2009 (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 the FIT-O study was to estimate the prevalence of having a caregiver (paid and/or informal) among hospitalized cardiac patients by demographic factors such as patient age and race/ethnicity, and to link caregiver status to clinical outcomes following hospitalization. A secondary aim was to collect anonymous family tree data to provide an estimate of the number of first degree family members, their basic demographics, and the distance at which they live from the medical center.
Detailed description
It has been established that cardiac caregivers are a vehicle by which health information can be transmitted, and that caregivers themselves may be at increased CVD risk. Our research evaluated the potential pool and demographic profile of cardiac caregivers as well as the role(s) they play in improving quality of patient care and to enhance adherence to secondary prevention guidelines post discharge. This research also provided important information about targeting educational efforts to specific caregivers to enhance the clinical outcomes of hospitalized coronary patients. The purpose of this study was to estimate the prevalence of caregiving in hospitalized cardiac patients by demographic factors such as patient age and race/ethnicity, and to link caregiving to clinical outcomes in cardiac patients. A secondary aim was to collect family tree data which would allow us to estimate the number of first degree family members, their basic demographics, and the distance at which they live from the medical center in order to determine the feasibility and scope of a targeted preventive intervention. The significance of this research is that it addressed specific challenges outlined in the recent NHLBI strategic plan to develop and evaluate programs to improve patient, provider, and health care system behavior and performance to enhance quality of care and health outcomes, especially in populations that experience a disproportionate disease burden. Unique information was obtained about caregivers as a potential intervention to improve preventive care and health outcomes of patients and families that suffer disproportionate CVD burden. Improved adherence to evidence-based preventive therapies could have a substantial public health benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular Service Line patients | – | –Patients admitted to the Cardiovascular Service Line at a major teaching hospital during a consecutive 11-month period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cardiovascular Service Line inpatients at Columbia University Medical Center/New York Presbyterian Hospital during a consecutive 11-month period.
Key inclusion criteria (1 listed)
- All inpatients admitted to the Cardiovascular Service Line at Columbia University Medical Center/New York-Presbyterian Hospital during a consecutive 11-month period will receive a survey as a routine part of hospital admission.
Key exclusion criteria (2 listed)
- Inability to read or understand English or Spanish.
- Refusal to complete survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the prevalence and demographic characteristics of cardiac caregivers among consecutively admitted patients with an acute atherosclerotic coronary event or surgical or catheter-based coronary revascularization procedure.
Time frame: Upon admission to a major academic teaching hospital
Cardiac caregivers were classified as either an unpaid family member or friend who assist the patient in complying with medical and lifestyle therapies post-discharge or as a paid professional caregiver. Standardized data were collected on the nature of the tasks the caregiver performs and the caregiver's relationship to the hospitalized patient.
1 secondary outcome
To determine the relation between having or not having a cardiac caregiver and patient clinical outcomes post hospital discharge adjusted for patient demographic characteristics, admitting diagnoses, and co-morbidities.
Time frame: At admission and 1-year post-hospital discharge
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 4 Jun 2024.
- Results publication: PubMed 23536121Aggarwal B, Liao M, Mosca L. Medication adherence is associated with having a caregiver among cardiac patients. Ann Behav Med. 2013 Oct;46(2):237-42. doi: 10.1007/s12160-013-9492-8.
- Results publication: PubMed 23321779Mochari-Greenberger H, Mosca M, Aggarwal B, Umann TM, Mosca L. Caregiver status: a simple marker to identify cardiac surgery patients at risk for longer postoperative length of stay, rehospitalization, or death. J Cardiovasc Nurs. 2014 Jan-Feb;29(1):12-9. doi: 10.1097/JCN.0b013e318274d19b.
- Results publication: PubMed 22901971Hammond G, Mochari-Greenberger H, Liao M, Mosca L. Effect of gender, caregiver, on cholesterol control and statin use for secondary prevention among hospitalized patients with coronary heart disease. Am J Cardiol. 2012 Dec 1;110(11):1613-8. doi: 10.1016/j.amjcard.2012.07.028. Epub 2012 Aug 15.
- Results publication: PubMed 21962999Mosca L, Aggarwal B, Mochari-Greenberger H, Liao M, Blair J, Cheng B, Comellas M, Rehm L, Suero-Tejeda N, Umann T. Association between having a caregiver and clinical outcomes 1 year after hospitalization for cardiovascular disease. Am J Cardiol. 2012 Jan 1;109(1):135-9. doi: 10.1016/j.amjcard.2011.07.072. Epub 2011 Sep 29.
- Results publication: PubMed 21330929Mosca L, Mochari-Greenberger H, Aggarwal B, Liao M, Suero-Tejeda N, Comellas M, Rehm L, Umann TM, Mehran R. Patterns of caregiving among patients hospitalized with cardiovascular disease. J Cardiovasc Nurs. 2011 Jul-Aug;26(4):305-11. doi: 10.1097/JCN.0b013e3181f34bb3.
- Results publication: PubMed 23468321Villanueva C, Aggarwal B. The association between neighborhood socioeconomic status and clinical outcomes among patients 1 year after hospitalization for cardiovascular disease. J Community Health. 2013 Aug;38(4):690-7. doi: 10.1007/s10900-013-9666-0.
- Results publication: PubMed 23416934Blair J, Volpe M, Aggarwal B. Challenges, needs, and experiences of recently hospitalized cardiac patients and their informal caregivers. J Cardiovasc Nurs. 2014 Jan-Feb;29(1):29-37. doi: 10.1097/JCN.0b013e3182784123.
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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.
Lori Mosca, MD, MPH, PhD principal investigator
Columbia University Medical Center/New York-Presbyterian Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Columbia University at 1 site 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 1 inclusion and 2 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 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To determine the prevalence and demographic characteristics of cardiac caregivers among consecutively admitted patients with an acute atherosclerotic coronary event or surgical or catheter-based coronary revascularization procedure. (time frame: Upon admission to a major academic teaching hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00990548, which also lists 7 linked publications.
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 4 Jun 2024.