Family Cardiac Caregiver Investigation to Evaluate Outcomes (FIT-O)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lori Mosca, Columbia University
ClinicalTrials.gov Identifier:
NCT00990548
First received: October 6, 2009
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition
Cardiovascular Diseases
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Family Cardiac Caregiver Investigation to Evaluate Outcomes (FIT-O)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 4500
Study Start Date: November 2009
Study Completion Date: July 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiovascular Service Line patients
Patients admitted to the Cardiovascular Service Line at a major teaching hospital during a consecutive 11-month period.

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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990548

Locations
United States, New York
Columbia University Medical Center/New York-Presbyterian Hosptial
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Lori Mosca, MD, MPH, PhD Columbia University Medical Center/New York-Presbyterian Hosptial
  More Information

Publications:

Responsible Party: Lori Mosca, Professor of Medicine, Columbia University., Columbia University
ClinicalTrials.gov Identifier: NCT00990548     History of Changes
Other Study ID Numbers: AAAE1561, R01HL075101-05A1, 2 R01 HL075101-05A1
Study First Received: October 6, 2009
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
Cardiac Caregivers
Cardiac Patient Clinical Outcomes
Prevention of CVD

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on August 26, 2014