Family Cardiac Caregiver Investigation to Evaluate Outcomes (FIT-O)
May 31, 2024 updated by: Columbia University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
4500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center/New York-Presbyterian Hosptial
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Cardiovascular Service Line inpatients at Columbia University Medical Center/New York Presbyterian Hospital during a consecutive 11-month period.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Inability to read or understand English or Spanish.
- Refusal to complete survey.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Cardiovascular Service Line patients
Patients admitted to the Cardiovascular Service Line at a major teaching hospital during a consecutive 11-month period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Upon admission to a major academic teaching hospital
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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At admission and 1-year post-hospital discharge
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To collect data regarding the number of family members and their proximity to the hospital to determine the feasibility of an extended family-centered educational and behavioral intervention targeted to family members of patients hospitalized with CVD.
Time Frame: The first 6 months of the study
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The first 6 months of the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lori Mosca, MD, MPH, PhD, Columbia University Medical Center/New York-Presbyterian Hosptial
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Mochari-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.
- Hammond 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.
- Mosca 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.
- Mosca 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.
- Villanueva 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.
- Blair 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
October 6, 2009
First Submitted That Met QC Criteria
October 6, 2009
First Posted (Estimated)
October 7, 2009
Study Record Updates
Last Update Posted (Estimated)
June 4, 2024
Last Update Submitted That Met QC Criteria
May 31, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAE1561
- R01HL075101-05A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.