title: A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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%).
  
  
  METHODS
  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.
  
  
  METHODS
  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
  Both intervention formats reduced CHD risk through 12-month follow-up. The web format was less expensive.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01245686.
authors.affiliation: Division of General Medicine and Clinical Epidemiology, School of Medicine, University of North Carolina, Chapel Hill2Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Keyserling
authors.affiliation: Division of General Medicine and Clinical Epidemiology, School of Medicine, University of North Carolina, Chapel Hill2Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill3Cecil G. Sheps Center for Health Services R.
authors.forename: Stacey L
authors.initials: SL
authors.lastname: Sheridan
authors.affiliation: Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill.
authors.forename: Lindy B
authors.initials: LB
authors.lastname: Draeger
authors.affiliation: Health Services and Systems Research Program, Duke-National University of Singapore Graduate Medical School, Singapore.
authors.forename: Eric A
authors.initials: EA
authors.lastname: Finkelstein
authors.affiliation: Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill.
authors.forename: Ziya
authors.initials: Z
authors.lastname: Gizlice
authors.affiliation: Health Services and Systems Research Program, Duke-National University of Singapore Graduate Medical School, Singapore.
authors.forename: Eliza
authors.initials: E
authors.lastname: Kruger
authors.affiliation: Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill.
authors.forename: Larry F
authors.initials: LF
authors.lastname: Johnston
authors.affiliation: Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill5Department of Family Medicine, School of Medicine, University of North Carolina, Chapel Hill.
authors.forename: Philip D
authors.initials: PD
authors.lastname: Sloane
authors.affiliation: Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill6Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill.
authors.forename: Carmen
authors.initials: C
authors.lastname: Samuel-Hodge
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill.
authors.forename: Kelly R
authors.initials: KR
authors.lastname: Evenson
authors.affiliation: Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis.
authors.forename: Myron D
authors.initials: MD
authors.lastname: Gross
authors.affiliation: Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill5Department of Family Medicine, School of Medicine, University of North Carolina, Chapel Hill.
authors.forename: Katrina E
authors.initials: KE
authors.lastname: Donahue
authors.affiliation: Division of General Medicine and Clinical Epidemiology, School of Medicine, University of North Carolina, Chapel Hill3Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Pignone
authors.affiliation: Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill.
authors.forename: Maihan B
authors.initials: MB
authors.lastname: Vu
authors.affiliation: Cabarrus Family Medicine, Kannapolis, North Carolina.
authors.forename: Erika A
authors.initials: EA
authors.lastname: Steinbacher
authors.affiliation: Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill.
authors.forename: Bryan J
authors.initials: BJ
authors.lastname: Weiner
authors.affiliation: Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill11Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill.
authors.forename: Shrikant I
authors.initials: SI
authors.lastname: Bangdiwala
authors.affiliation: Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill5Department of Family Medicine, School of Medicine, University of North Carolina, Chapel Hill6Department of Nutrition, Gillings School of Global Public Health, Un.
authors.forename: Alice S
authors.initials: AS
authors.lastname: Ammerman
mesh_terms: D000328:Adult; D000368:Aged; D003327:Coronary Disease / Q000188:drug therapy* / Q000517:prevention & control* / Q000523:psychology; D037001:Directive Counseling / Q000191:economics; D005260:Female; D006801:Humans; D020407:Internet / Q000191:economics; D008019:Life Style; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D040242:Risk Reduction Behavior