A Comparison of Live Counseling with a Web-Based Lifestyle and Medication Intervention to Reduce Coronary Risk A Randomized Clinical Trial
Published Date:Jul 2014
Source:JAMA Intern Med. 174(7):1144-1157.
Pubmed Central ID:PMC4142754
Funding:1U48DP002658/DP/NCCDPHP CDC HHS/United States
P30 DK056350/DK/NIDDK NIH HHS/United States
P30 DK093002/DK/NIDDK NIH HHS/United States
P30DK056350/DK/NIDDK NIH HHS/United States
U48/DP001944/DP/NCCDPHP CDC HHS/United States
UL1 TR001111/TR/NCATS NIH HHS/United States
Most primary care clinicians lack the skills and resources to offer effective lifestyle and medication 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 lifestyle and medication intervention to reduce CHD risk offered in counselor-delivered and web-based formats.
Comparative effectiveness trial.
Five diverse family medicine practices in North Carolina.
Established patients, age 35–79, 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 utilized 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.
Main Outcome and Measures
Outcomes were assessed at 4 and 12 months; the primary outcome was within group change in FRS at 4 month follow-up. Other measures included standardized assessments of blood pressure, blood lipids, lifestyle behaviors, and medication adherence. Acceptability and cost-effectiveness were also assessed.
Of 2,274 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 was 91% and 87%, respectively. There was a sustained reduction in FRS at both 4 (primary outcome) and 12 month follow-up: for counselor, −2.3% (95% CI: −3.0% to −1.6%) and −1.9% (−2.8% to −1.1%) and for web, −1.5% (−2.2% to −0.9%) and −1.7%, (−2.6% to −0.8%) respectively. At 4 month follow-up, the adjusted difference in FRS between groups was −1.0% (95% CI −1.8% to −0.1%, p = 0.03) at 12 month follow-up, 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 interventions respectively.
Conclusions and Relevance
Both intervention formats reduced CHD risk through 12 month follow-up. The web format was less expensive.
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