Activating peripheral arterial disease patients to reduce cholesterol: a randomized trial

Abstract

Background: Peripheral arterial disease patients are less likely than other high-risk patients to achieve ideal low-density lipoprotein (LDL) cholesterol levels. This randomized controlled trial assessed whether a telephone counseling intervention, designed to help peripheral arterial disease patients request more intensive cholesterol-lowering therapy from their physician, achieved lower LDL cholesterol levels than 2 control conditions.

Methods: There were 355 peripheral arterial disease participants with baseline LDL cholesterol ≥70 mg/dL enrolled. The primary outcome was change in LDL cholesterol level at 12-month follow-up. There were 3 parallel arms: telephone counseling intervention, attention control condition, and usual care. The intervention consisted of patient-centered counseling, delivered every 6 weeks, encouraging participants to request increases in cholesterol-lowering therapy from their physician. The attention control condition consisted of telephone calls every 6 weeks providing information only. The usual care condition participated in baseline and follow-up testing.

Results: At 12-month follow-up, participants in the intervention improved their LDL cholesterol level, compared with those in attention control (-18.4 mg/dL vs -6.8 mg/dL, P=.010) but not compared with those in usual care (-18.4 mg/dL vs -11.1 mg/dL, P=.208). Intervention participants were more likely to start a cholesterol-lowering medication or increase their cholesterol-lowering medication dose than those in the attention control (54% vs 18%, P=.001) and usual care (54% vs 31%, P <.001) conditions.

Conclusion: Telephone counseling that helped peripheral arterial disease patients request more intensive cholesterol-lowering therapy from their physician achieved greater LDL cholesterol decreases than an attention control arm that provided health information alone.

Trial registration: ClinicalTrials.gov NCT00217919.

Figure 1

STUDY PARTICIPATION AND FOLLOW-UP RATES