A Comparison of Counseling With a Web-Based Lifestyle and Medication Intervention to Reduce Coronary Heart Disease Risk: A Randomized Clinical Trial

Study Questions:

Does a lifestyle and medication intervention, delivered by counselors or web-based format, result in effective reduction in coronary heart disease (CHD) risk?

Methods:

This was a comparative effectiveness trial in five diverse family medicine practices in North Carolina. Participants were ages 35-79 years without known cardiovascular disease at baseline, but at moderate to high risk for CHD (defined from the Framingham Risk Score, 10-year risk ≥10%). Participants were randomized to counselor-delivered or web-based format, each including four intensive and three maintenance sessions. After randomization, both formats used a web-based decision aid showing potential CHD risk reduction associated with lifestyle and medication risk-reducing strategies. Participants chose the risk-reducing strategies they wished to follow. The primary outcome was within-group change in Framingham Risk Score at 4-month follow-up. Other measures included standardized assessments of blood pressure, blood lipid levels, lifestyle behaviors, and medication adherence. Acceptability and cost-effectiveness were also assessed. Outcomes were assessed at 4 and 12 months.

Results:

A total of 2,274 patients were screened, of which 385 were randomized (192 to the counselor-delivered intervention and 193 to the web-based intervention). The mean age of the cohort was 62 years, 24% were African American, and the mean Framingham Risk Score was 16.9% at baseline. Follow-up at 4 and 12 months included 91% and 87% of the randomized participants, respectively. There was a sustained reduction in Framingham Risk Score at both 4 months (primary outcome) and 12 months for both counselor-based (−2.3% [95% confidence interval (CI), −3.0% to −1.6%] and −1.9% [95% CI, −2.8% to −1.1%], respectively) and web-based groups (−1.5% [95% CI, −2.2% to −0.9%] and −1.7% [95% CI, −2.6% to −0.8%], respectively). At 4 months, the adjusted difference in Framingham Risk Score between groups was −1.0% (95% CI, −1.8% to −0.1%) (p = 0.03), and at 12 months, it was −0.6% (95% CI, −1.7% to 0.5%) (p = 0.30). The 12-month costs from the payer perspective were $207 and $110 per person for the counselor- and web-based interventions, respectively.

Conclusions:

The investigators concluded that both intervention formats reduced CHD risk through 12-month follow-up. The web-based format was less expensive.

Perspective:

These data suggest that interventions which successfully modify lifestyle and medication adherence can result in reducing CHD risk among high-risk patients at a relatively low cost. Web-based intervention can conceivably be used long-term to promote long-term adherence to healthy lifestyle and preventive medications; however, further research is needed to address such questions.

Clinical Topics: Atherosclerotic Disease (CAD/PAD)

Keywords: Medication Adherence, Coronary Artery Disease, Life Style, Follow-Up Studies, Decision Support Techniques, Risk Reduction Behavior, Counseling, Blood Pressure, United States


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