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Clinical Trials/NCT01245686
NCT01245686
Completed
Not Applicable

A Combined Lifestyle and Medication Intervention to Reduce CVD Risk

University of North Carolina, Chapel Hill5 sites in 1 country489 target enrollmentFebruary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Disease
Sponsor
University of North Carolina, Chapel Hill
Enrollment
489
Locations
5
Primary Endpoint
Predicted 10-year CHD risk
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health care and lost productivity.

Both lifestyle changes and medication can reduce the risk of CVD, and this project combines these approaches in the hopes of identifying a practical intervention for use in primary care medical offices. The project combines two previously tested interventions and updates them to meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs (statins).

The research team is delivering the combined intervention in two formats: web-based and counselor-based. Each format has the same content, but the web-based advice is accessed through the Internet by clients at home, a community site, or a primary care office. The other format involves sessions delivered to clients by a counselor either in person at a primary care office or over the telephone. The researchers will compare how effective each format is in reducing participants' risk of coronary heart disease. They will also determine the interventions' effect on participants' diet, physical activity, smoking status, medication adherence, and other health indicators. In addition, the team will compare the two formats' cost-effectiveness and how well the patients, office staff, and clinicians accept the interventions.

Recruited from five family practices, 600 patients representing the geographic and ethnic diversity of North Carolina are taking part in this study. Half the participants are randomly assigned to the web-based intervention; the other half to the counselor-based version. Both groups will also get information on local resources, such as gyms and farmers markets, that can help participants maintain a healthy lifestyle.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
November 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas Keyserling, MD, MPH

Professor of Medicine

University of North Carolina, Chapel Hill

Eligibility Criteria

Inclusion Criteria

  • Established patients
  • Men ages 35-79
  • Women ages 45-79
  • History of CVD (100 participants)
  • CHD risk equal or greater than 10%
  • elevated CHD risk factor

Exclusion Criteria

  • non-English speaking
  • treatment of psychosis
  • history of alcohol/substance abuse within last 2 years
  • pregnancy, breast feeding, or anticipated pregnancy in next 18 months
  • history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for \>5 years
  • recent history (in past year) of hypoglycemic event requiring medical attention
  • estimated creatinine clearance less than 30 ml/min

Outcomes

Primary Outcomes

Predicted 10-year CHD risk

Time Frame: 4-month follow-up

Framingham risk scores are well-validated and provide an absolute estimate of the likelihood of CHD events (MI, angina, and CHD death) over a 10-year time period. We will examine absolute changes in this outcome in both intervention arms. We will also examine whether this outcome varies by subgroups of the following variables: baseline level of predicted CHD risk, age, race, SES, insurance status, overall health status, numeracy, literacy, # medications, # of perceived barriers to adherence, use of the intervention, time with the intervention, study practice site, and health counselor

Secondary Outcomes

  • Predicted 10-year CHD risk(12 months)
  • Use of and adherence to cardiovascular medicines(4 and 12 months)
  • Dietary Intake(4 and 12 months)
  • Physical activity(4 and 12 months)
  • Blood pressure(4 and 12 months)
  • Total, HDL, and direct LDL cholesterol(4 and 12 months)
  • Smoking status(4 and 12 months)
  • Adverse events(4 and 12 months)
  • Acceptability of the Intervention(4 and 12 months)
  • Cost-effectiveness(4 and 12 months)

Study Sites (5)

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