Departments of Community Health Sciences (D.J.T.C., M.T., P.F., J.Z., F.A., J.F., D.V.E., B.J.M.), University of Calgary, Alberta, Canada.
Medicine (D.J.T.C., M.T., B.J.M.), University of Calgary, Alberta, Canada.
Circulation. 2023 May 16;147(20):1492-1504. doi: 10.1161/CIRCULATIONAHA.123.064189. Epub 2023 Mar 5.
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 effect on clinical end points. Advertising for commercial products is known to influence behavior, but advertising principles are not typically incorporated into SMES design.
This randomized trial studied the effect of a novel tailored SMES program designed by an advertising firm among a population of older adults with low income 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 [EuroQoL 5-dimension] index score), medication adherence, and overall health care costs.
We randomized 4761 individuals, with a mean age of 74.4 years, of whom 46.8% were female. There was no evidence of statistical interaction (=0.99) or of a synergistic effect between the 2 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, 0.78 [95% CI, 0.61 to 1.00]; =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]; =0.99). The proportion of participants who were adherent to medications was not different between the 2 groups (=0.199 for statins and =0.754 for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers). Overall adjusted health care costs did not differ between those receiving SMES and the control group ($2015 [95% CI, -$1953 to $5985]; =0.320).
For older adults with low income, a tailored SMES program using advertising principles reduced the rate of clinical outcomes compared with usual care. The mechanisms of improvement are unclear and further studies are required.
URL: https://www.
gov; Unique identifier: NCT02579655.
自我管理教育和支持（SMES）干预措施对心血管疾病风险人群的中间结果有一定的影响，但很少有研究测量或证明其对临床终点有影响。广告商通常会利用广告来影响行为，但广告原则通常不会被纳入 SMES 设计中。
这项随机试验研究了一种由广告公司设计的新型定制 SMES 计划对加拿大艾伯塔省高心血管风险、低收入老年人群的影响。该干预措施包括来自虚构“同行”的健康促进信息，以及促进将临床信息转递给患者的初级保健提供者和药剂师。主要结局是死亡、心肌梗死、卒中和冠状动脉血运重建，以及因心血管相关门诊护理敏感疾病而住院的综合结果。主要结局及其组成部分的发生率使用负二项回归进行比较。次要结局包括生活质量（EQ-5D[欧洲五维健康量表]指数评分）、药物依从性和整体医疗保健费用。
我们随机分配了 4761 名平均年龄为 74.4 岁的个体，其中 46.8%为女性。在两因素试验中，我们没有发现这两种干预措施在主要结局方面存在统计学交互作用（=0.99）或协同效应，这使我们能够分别评估每种干预措施的效果。在中位随访时间为 36 个月期间，与对照组相比，接受 SMES 的组的主要结局发生率较低（发生率比，0.78 [95%CI，0.61 至 1.00]；=0.047）。没有观察到随着时间的推移，生活质量在组间有显著变化（平均差异，0.0001 [95%CI，-0.018 至 0.018]；=0.99）。两组之间药物依从性的比例没有差异（=0.199 用于他汀类药物，=0.754 用于血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂）。接受 SMES 组和对照组的总体调整医疗保健费用没有差异（$2015 [95%CI，-$1953 至 $5985]；=0.320）。
对于低收入的老年人，使用广告原则的定制 SMES 计划可降低临床结果的发生率，优于常规护理。改善的机制尚不清楚，需要进一步研究。
gov；唯一标识符：NCT02579655。
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