Centre for Implementation Research, Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital - General Campus, 501 Smyth Road, K1H 8L6, Ottawa, Ontario, Canada.
School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
J Behav Med. 2022 Oct;45(5):659-673. doi: 10.1007/s10865-022-00327-0. Epub 2022 May 20.
Investigating the mechanisms of behavior change interventions provides a more fulsome understanding of how and why interventions work (or don't work). We assessed mechanisms of two interventions (mailouts alone, and mailouts plus telephone support, informed by the Health Action Process Approach (HAPA) and Habit Theory), designed to increase medication adherence after myocardial infarction. We conducted a process evaluation alongside a pragmatic trial. Medication adherence was assessed via self-report at 12-months in the trial, and participants in all trial groups were invited to contemporaneously complete an additional questionnaire assessing targeted mechanisms (HAPA constructs and automaticity). We used multiple regression-based mediation models to investigate indirect effects. Of 589 respondents, 497 were analyzed (92 excluded due to missing data). Mailouts plus telephone support had statistically significant but small effects on intention, social support, action planning, coping planning, and automaticity. There were no indirect effects of interventions on medication adherence via these constructs. Therefore, while this intervention led to changes in proposed mechanisms, these changes were not great enough to lead to behavior change. Refinements (and subsequent evaluation) of the interventions are warranted, and our findings indicate that this could involve offering more intensive support to form plans and identify cues for taking medications, in addition to providing physical supports to encourage self-monitoring, feedback, and habit formation. Trial registration: ClinicalTrials.gov: NCT02382731.
研究行为改变干预措施的机制可以更全面地了解干预措施的作用机制和原因（或不起作用的原因）。我们评估了两种干预措施（仅邮寄和邮寄加电话支持，基于健康行动过程方法（HAPA）和习惯理论设计）的机制，旨在增加心肌梗死后的药物依从性。我们在一项实用试验中进行了过程评估。在试验中，通过自我报告在 12 个月时评估药物依从性，邀请所有试验组的参与者同时完成一份额外的问卷，评估目标机制（HAPA 结构和自动性）。我们使用基于多元回归的中介模型来研究间接效应。在 589 名应答者中，对 497 名进行了分析（由于数据缺失，92 名被排除在外）。邮寄加电话支持对意图、社会支持、行动计划、应对计划和自动性有统计学上显著但较小的影响。这些结构没有干预对药物依从性的间接影响。因此，虽然这种干预措施导致了提议的机制发生变化，但这些变化不足以导致行为改变。有必要对干预措施进行改进（和随后的评估），我们的研究结果表明，这可能涉及提供更密集的支持来制定计划和确定服用药物的线索，以及提供物理支持来鼓励自我监测、反馈和习惯形成。试验注册：ClinicalTrials.gov：NCT02382731。
