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Original Investigation |

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

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
[+] Author Affiliations
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
JAMA Intern Med. 2014;174(7):1144-1157. doi:10.1001/jamainternmed.2014.1984.
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Importance  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.

Objective  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%).

Interventions  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.

Results  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

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Figure 1.
Study Flow Diagram

MI indicates myocardial infarction; CHD, coronary heart disease.aAt baseline there were 55 smokers in the counselor intervention and 58 smokers in the web-based intervention.bIncludes intent to start or increase regimen of blood pressure or cholesterol medication or start taking aspirin.

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Figure 2.
Change in Framingham Risk Score (FRS)

Stratified on selected baseline variables, shown by treatment arm at 4- and 12-month follow-up.aAt 4-month follow-up, P ≤ .05 for comparison of FRS between subgroups with web and counselor groups combined.bAt 12-month follow-up, P ≤ .05 for same comparison.

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