A Comparison of Live Counseling With a Web-Based Lifestyle and Medication Intervention to Reduce Coronary Heart Disease RiskA Randomized Clinical Trial. JAMA Internal Medicine. Published online May 26, 2014 Thomas C. Keyserling, MD, MPH1,2; Stacey L. Sheridan, MD, MPH1,2,3; Lindy B. Draeger, MPH2; Eric A. Finkelstein, PhD, MA, MHA4; Ziya Gizlice, PhD2; Eliza Kruger, MHE4; Larry F. Johnston, MA2; Philip D. Sloane, MD3,5; Carmen Samuel-Hodge, PhD, RD2,6; Kelly R. Evenson, PhD, MS7; Myron D. Gross, PhD8; Katrina E. Donahue, MD, MPH3,5; Michael P. Pignone, MD, MPH1,3; Maihan B. Vu, DrPH, MPH2; Erika A. Steinbacher, MD9; Bryan J. Weiner, PhD10; Shrikant I. Bangdiwala, PhD2,11; Alice S. Ammerman, DrPH, RD2,5,6
1Division of General Medicine and Clinical Epidemiology, School of Medicine, University of North Carolina, Chapel Hill; 2Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill; 3Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill; 4Health Services and Systems Research Program, Duke–National University of Singapore Graduate Medical School, Singapore; 5Department of Family Medicine, School of Medicine, University of North Carolina, Chapel Hill; 6Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill; 7Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill; 8Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis; 9Cabarrus Family Medicine, Kannapolis, North Carolina; 10Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill; 11Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill
Most primary care clinicians lack the skills and resources to offer effective lifestyle and medication (L&M) counseling to reduce coronary heart disease (CHD) risk. Thus, effective and feasible CHD prevention programs are needed for typical practice settings.
To assess the effectiveness, acceptability, and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats.
Design, Setting, and Participants
A comparative effectiveness trial in 5 diverse family medicine practices in North Carolina. Participants were established patients, aged 35 to 79 years, with no known cardiovascular disease, and at moderate to high risk for CHD (10-year Framingham Risk Score [FRS], ≥10%).
Participants were randomized to counselor-delivered or web-based format, each including 4 intensive and 3 maintenance sessions. After randomization, both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies. Participants chose the risk-reducing strategies they wished to follow.
Main Outcomes and Measures
The primary outcome was within-group change in FRS 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.
Of 2274 screened patients, 385 were randomized (192 counselor; 193 web): mean age, 62 years; 24% African American; and mean FRS, 16.9%. Follow-up at 4 and 12 months included 91% and 87% of the randomized participants, respectively. There was a sustained reduction in FRS at both 4 months (primary outcome) and 12 months for both counselor-based (−2.3% [95% 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 FRS between groups was −1.0% (95% CI, −1.8% to −0.1%) (P = .03), and at 12 months, it was −0.6% (95% CI, −1.7% to 0.5%) (P = .30). The 12-month costs from the payer perspective were $207 and $110 per person for the counselor- and web-based interventions, respectively.
Conclusions and Relevance
Both intervention formats reduced CHD risk through 12-month follow-up. The web format was less expensive.
Trial Registration clinicaltrials.gov Identifier: NCT01245686