Evaluating a Web-Based Educational Program for Adults at Risk for Coronary Heart Disease (The Heart to Heart Feasibility Study)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stacey Sheridan, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00494052
First received: June 28, 2007
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

Coronary heart disease (CHD) is the leading cause of death in the United States, but fewer than half of all individuals at risk for CHD take advantage of proven strategies to lower their chances of developing this disease. This study will assess the effectiveness of Heart to Heart, a Web-based program, at educating people on ways to incorporate CHD risk-reduction strategies into their lives.


Condition Intervention
Coronary Disease
Cardiovascular Diseases
Behavioral: Heart to Heart (Web-Based Decision Aid)
Behavioral: Physician Education Session

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Intervention to Enhance CHD Risk Factor Modification: The Heart to Heart Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes [ Time Frame: Measured at the end of the study period (approximately 2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported use of any new CHD risk reduction strategy; global CHD risk; blood pressure; serum total cholesterol and HDL-c levels; smoking status; aspirin use; self-reported plans for CHD risk reduction; self-efficacy for CHD risk reduction [ Time Frame: Measured at participants' Month 3 study visit ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Heart to Heart intervention
Behavioral: Heart to Heart (Web-Based Decision Aid)
Participants in the intervention group will access Heart to Heart, a Web site designed to educate them about their overall CHD risk, specific risk factors, and strategies and preferences for risk reduction.
Behavioral: Physician Education Session
A physician education session will be included in the program.
No Intervention: 2
Usual care

Detailed Description:

CHD affects 13 million people in the United States. It is the leading cause of death in this country, and each year more than half a million Americans die from this disease. People who take steps to lower their cholesterol and blood pressure levels, lose weight, and stop smoking may be less likely to develop CHD. However, fewer than half of all individuals at risk for developing CHD follow these suggestions. Involving patients in the decision-making process regarding their medical care may improve their adherence to effective CHD prevention strategies. The goal of the Heart to Heart program is to provide information about CHD risk factors and encourage people to incorporate the appropriate risk-reduction measures into their lives. The purposes of this pilot study are to evaluate the ability of study researchers to recruit individuals with a moderate to high risk of CHD to participate in the study; to conduct a four-part CHD intervention (Heart to Heart) in a busy medical practice setting; and to measure participants' decision-making plans, self-reported adherence to medications, and changes in overall CHD risk factors. The results from this study will be used to guide future clinical trials.

This study will enroll patients being treated at the General Internal Medicine Clinic at the University of North Carolina at Chapel Hill who have a moderate to high risk of developing CHD. At an initial study visit, participants will complete questionnaires that assess CHD risk-reduction strategies, smoking status, and aspirin use. Blood pressure and cholesterol levels will also be measured. Participants will then be randomly assigned to either participate in the Heart to Heart intervention or receive usual care. Participants in the intervention group will access Heart to Heart, a Web site designed to educate them about their overall CHD risk, specific risk factors, and strategies and preferences for risk reduction. A Web-based coaching tool will encourage participants to talk with their doctor about risk-reduction choices. Participants will also receive brief adherence messages via the Web site 2, 4, and 6 weeks following their initial study visit. The messages will be designed to help participants adhere to their decisions. All participants will attend a study visit at Month 3 for repeat baseline testing. Following this visit, participants will receive a letter that includes their test results and their recalculated CHD risk. Participants may be contacted to take part in a focus group following the completion of the study.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently a patient at the General Internal Medicine Clinic at the University of North Carolina at Chapel Hill
  • Moderate (6% to 20%) or high (greater than 20%) risk of CHD, as defined by current evidence and practice-based guidelines for aspirin use and cholesterol levels

Exclusion Criteria:

  • Known cardiovascular disease (e.g., previous heart attack, previous coronary artery bypass graft or percutaneous coronary intervention, angina, previous transient ischemic attack [TIA] or stroke, peripheral vascular disease, congestive heart failure)
  • Diabetes
  • Low global risk of CHD (less than 6%)
  • Dementia or other severe cognitive dysfunction
  • Blindness
  • Serious medical illness that would make the individual a poor candidate for the study (e.g., kidney failure, liver cirrhosis, HIV, non-skin cancer, any other illness for which their life expectancy is projected at less than 5 years)
  • Inability to speak and understand English
  • Participation in the preliminary study or in cognitive testing of intervention components
  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: NCT00494052

Locations
United States, North Carolina
UNC General Internal Medicine Clinic
Chapel Hill, North Carolina, United States, 27599
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Stacey L. Sheridan, MD, MPH University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stacey Sheridan, MD, Stacey L. Sheridan, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00494052     History of Changes
Other Study ID Numbers: 490, K23HL074375-02, K23 HL074375-02
Study First Received: June 28, 2007
Last Updated: January 25, 2013
Health Authority: United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Coronary Heart Disease
Choice Behavior
Risk Factors
Risk Assessment
Primary Prevention
Decision Making
Decision Aids
Patient Compliance

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014