Background:
Self-management education and support (SMES) interventions have modest effects on intermediate outcomes for those at risk of cardiovascular disease, but few studies have measured or demonstrated an impact on clinical endpoints. Advertising for commercial products is known to influence behavior, but advertising principles are not typically incorporated into SMES design.
Methods:
This randomized trial studied the impact of a novel tailored SMES program designed by an advertising firm among a population of low-income older adults at high cardiovascular risk in Alberta, Canada. The intervention included health promotion messaging from a fictitious "peer" and facilitated relay of clinical information to patients' primary care provider and pharmacist. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and hospitalizations for cardiovascular-related ambulatory care-sensitive conditions. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (EQ-5D index score), medication adherence, and overall healthcare costs.
Results:
We randomized 4,761 individuals, with a mean age of 74.4 years, of whom 46.8% were female. There was no evidence of statistical interaction (p=0.99) or of a synergistic effect between the two interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. Over a median follow-up time of 36 months, the rate of the primary outcome was lower in the group that received SMES compared with the control group (incidence rate ratio (IRR): 0.78, 95% confidence interval (CI): 0.61-1.00, p=0.047). No significant between-group changes in quality of life over time were observed (mean difference 0.0001, 95%CI -0.018 to 0.018, p=0.99). The proportion of participants who were adherent to medications was not different between the two groups (p = 0.199 for statins, and p=0.754 for ACEi/ARBs). Overall adjusted health care costs did not differ between those receiving SMES and the control group ($2,015, 95%CI -1,953 to 5,985, p=0.320).
Conclusions:
In low-income older adults, a tailored SMES program using advertising principles reduced the rate of clinical outcomes compared with usual care, though the mechanisms of improvement are unclear and further studies are required.