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Evaluating the Effectiveness of a Family Heart Health Educational Program (The FIT-Heart Study)
This study has been completed.

First Received on August 4, 2008.   Last Updated on August 29, 2008   History of Changes
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00728637
  Purpose

Coronary heart disease (CHD) affects millions of people in the United States and is an increasingly important health problem. People who have a family member with CHD may have a higher risk for developing CHD because of shared genetic factors and similar lifestyles. This study will evaluate the effectiveness of the Family Passport to Heart Health Program, which is a personalized screening and education program aimed at lowering CHD risk for family members of patients hospitalized with CHD.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
 Behavioral: Family Passport to Heart Health Program
Behavioral: General Educational Materials

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of a Family Heart Health Intervention Trial (FIT Heart I)

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxine-dependent epilepsy
MedlinePlus related topics: Cholesterol Heart Diseases Seizures
U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Mean percent reduction in low-density lipoprotein (LDL) cholesterol levels in the Family Passport to Heart Health Program group versus the control group [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean percent change in high density lipoprotein (HDL) cholesterol levels in the Family Passport to Heart Health Program group versus the control group [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Attainment of the Therapeutic Lifestyle Change (TLC) diet [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Change in lipoproteins, high sensitivity C-reactive protein (hsCRP), blood pressure, body mass index, waist circumference, Framingham risk, and diet score in the Family Passport to Heart Health Program group versus the control group [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Cost effectiveness of the personalized educational program to reduce LDL cholesterol levels and cost per life saved [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Impact of hsCRP beyond traditional risk factors on attainment of prevention goals [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Enrollment: 501
Study Start Date: January 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will take part in the Family Passport to Heart Health Program.
 Behavioral: Family Passport to Heart Health Program
Participants in this group will receive personalized heart disease risk factor screening at the baseline study visit. They will be taught lifestyle approaches to risk reduction based upon national heart disease prevention guidelines, including the Adult Treatment Panel (ATP) III recommendations for improving blood cholesterol levels with a TLC diet. Participants will have regular contact with study staff and will receive individualized feedback throughout the study.
Active Comparator: 2
Participants will take part in a control group.
 Behavioral: General Educational Materials
Participants in the control group will receive an educational brochure about heart health at the baseline study visit.

Detailed Description:

CHD is the leading cause of death in the United States, with almost 700,000 people dying each year as a result of the disease. Risk factors for CHD include diabetes, high blood pressure, obesity, smoking, and lack of exercise. In addition, genetics may play a role in the development of CHD. Because of shared genetic factors and similar lifestyles and health habits, family members of individuals with CHD have an increased risk of developing the disease. When a family member is hospitalized for CHD, it may represent a "motivational moment" for other family members to determine their own CHD risk and to take action to lower it. The Family Passport to Heart Health Program is a hospital outreach screening and education program that aims to identify family members of people with CHD and provide personalized education to help them follow a heart healthy lifestyle and reduce CHD risk factors. The purpose of this study is to evaluate the effectiveness of the Family Passport to Heart Health Program at reducing CHD risk factors.

This study will enroll family members of patients hospitalized at New York Presbyterian Hospital because of CHD symptoms. Participants will be randomly assigned to either the Family Passport to Heart Health Program or a control group. At a baseline study visit, all participants will undergo a blood collection; measurements of blood pressure, height, weight, and waist circumference; and a carbon monoxide breath test to assess tobacco smoke exposure. Questionnaires will be completed to evaluate diet, health habits, and medical status. Participants in the Family Passport to Heart Health Program will also undergo a finger stick blood test to measure heart disease risk factors, including cholesterol levels. Study researchers will then provide these participants with feedback on their test results, personalized education on how to lower their risk factors, and educational materials. At the baseline study visit, participants in the control group will also undergo a medical record review and will receive an educational brochure that includes information on general lifestyle tips to maintain heart health.

At Months 3, 6, and 9, participants in the Family Passport to Heart Health Program will undergo repeat finger stick tests, a diet assessment, and discussions on lifestyle, risk factor goals, and prevention barriers with study staff. They will also receive phone calls at Weeks 2, 6, 12, 24, and 36 from study staff to discuss progress. Progress reports for these participants will be sent to their doctors after each study visit. At Month 6, participants in the control group will undergo a medical record review. All participants will be mailed questionnaires at Month 6 to collect information on risk factors, lifestyle factors, and medical information. At Year 1, all participants will attend a study visit for repeat baseline testing, and results will be sent to participants' doctors. After the completion of the study, the control group participants will take part in the Family Passport to Heart Health Program.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Life expectancy of at least 5 years after study entry
  • Willing to return at Year 1 for a repeat study evaluation
  • Family member was hospitalized with acute atherosclerotic cardiovascular disease, including catheter-based procedures and coronary artery bypass grafting
  • Speaks either English or Spanish

Exclusion Criteria:

  • Established cardiovascular disease, diabetes, active liver disease, or long-term kidney disease
  • Life expectancy less than 5 years from study entry
  • Prescription of a special diet that is not compatible with the TLC diet
  • Participation in a clinical drug study in the 3 months before study entry
  • Pregnant or planning to become pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728637

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Lori Mosca, MD, MPH, PhD Columbia University
  More Information

Publications:
Edelman DJ, Gao Q, Mosca L. Predictors and barriers to timely medical follow-up after cardiovascular disease risk factor screening according to race/ethnicity. J Natl Med Assoc. 2008 May;100(5):534-9.
Mochari H, Gao Q, Mosca L. Validation of the MEDFICTS dietary assessment questionnaire in a diverse population. J Am Diet Assoc. 2008 May;108(5):817-22.
Fischer Aggarwal BA, Liao M, Mosca L. Physical activity as a potential mechanism through which social support may reduce cardiovascular disease risk. J Cardiovasc Nurs. 2008 Mar-Apr;23(2):90-6.

Responsible Party: Lori Mosca, MD, MPH, PhD, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00728637     History of Changes
Other Study ID Numbers: 593, R01 HL075101
Study First Received: August 4, 2008
Last Updated: August 29, 2008
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Prevention

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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