Heart to Health
A healthy lifestyle and appropriate use of medication can substantially reduce cardiovascular disease (CVD) risk, yet both remain underused forms of treatment. This study will combine two previously tested and effective lifestyle and medication interventions to reduce CVD risk and test this intervention in a diverse group of patients cared for at family practices in North Carolina.
To assess the effect of two clinically relevant alternative interventions (one web-based and one counselor-based) on predicted coronary heart disease (CHD) risk at 4 and 12 month follow-up, as estimated by the Framingham Risk Equation.
In recognition of increasing access to the internet and differing costs and in-puts related to web-based vs. counselor-based interventions, we will compare the effectiveness and feasibility of a combined lifestyle and medication intervention in two formats: web-based and counselor-based. Using a comparative effectiveness research framework, we plan to compare these intervention formats for their impact on estimated CVD risk reduction and other important outcomes to key clinical and public health stakeholders (patients, payers, and decision makers); in particular, feasibility, acceptability, and cost-effectiveness outcomes. To do so, we will conduct this study at 5 family practices, enrolling 120 patients per practice. We will randomize participants within site to one of the 2 treatment conditions, both including a baseline assessment and a theory informed intervention with a 4 month intensive phase (4 sessions) and an 8 month maintenance phase (3 contacts). Outcomes will be assessed at 4 and 12 months, with the primary outcome a reduction in the estimated 10 year risk of coronary heart disease as determined by the Framingham equation. Changes in dietary intake, physical activity, blood pressure, blood lipids, and medication use, in addition to feasibility, acceptability and cost, are important secondary outcomes.
To optimize dissemination of study findings to decision makers and the interventions to practitioners, we will 1) elicit input from stakeholders at the outset to guide our development of the intervention and 2) use an existing web-based mechanism, (Center of Excellence for Training and Research Translation) for intervention training, translation, and dissemination.
- Center for Disease Control and Prevention (CDC), July 14, 2010- July 13, 2012
Thomas C. Keyserling, MD, MPH
Stacey L. Sheridan, MD, MPH
Lindy B. Draeger, MPH