NCT00990548

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

October 6, 2009

Last Update Submit

May 31, 2024

Conditions

Keywords

Cardiac CaregiversCardiac Patient Clinical OutcomesPrevention of CVD

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    At admission and 1-year post-hospital discharge

Other Outcomes (1)

  • 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.

    The first 6 months of the study

Study Arms (1)

Cardiovascular Service Line patients

Patients admitted to the Cardiovascular Service Line at a major teaching hospital during a consecutive 11-month period.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiovascular Service Line inpatients at Columbia University Medical Center/New York Presbyterian Hospital during a consecutive 11-month period.

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to read or understand English or Spanish.
  • Refusal to complete survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center/New York-Presbyterian Hosptial

New York, New York, 10032, United States

Location

Related Publications (7)

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Study Officials

  • Lori Mosca, MD, MPH, PhD

    Columbia University Medical Center/New York-Presbyterian Hosptial

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 7, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

July 1, 2012

Last Updated

June 4, 2024

Record last verified: 2024-05

Locations