The effect of a multi-component behavior change technique intervention on medication adherence among individuals on primary prevention statin therapy: a dose-finding protocol.
The effect of a multi-component behavior change technique intervention on medication adherence among individuals on primary prevention statin therapy: a dose-finding protocol.
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在美国，死亡和发病的主要原因仍然是心血管疾病（CVD）。许多试验表明，他汀类药物降低了CVD事件的可能性;它是CVD预防的基石。然而，研究还表明，在估计的2680万美国人中，高达60%的一级预防他汀类药物治疗在第一年内没有依从。多成分行为改变技术（BCT）疗法在改善药物依从性以及其他积极的健康行为（如体力活动）方面表现出适度的承诺。然而，没有研究关注多组分BCT干预所需的持续时间，以导致他汀类药物依从性行为的临床显著改善。本研究旨在确定多组分BCT干预的必要剂量（定义为持续时间，以周为单位），以通过使用改良的至事件时间连续再评估方法（TiTE-CRM）促进接受一级预防他汀类药物治疗的患者对他汀类药物的依从性。本研究将在42名参与者中使用改良的TiTE-CRM，招募14个队列，每个队列3名参与者。本分析的目的是确定多行为改变技术（BCT）干预所需的最小有效剂量（MED），以使基线和随访期间对他汀类药物的依从性增加20%。使用TiTE-CRM方法，基于先前队列的表现，将行为干预的剂量（周）分配给每个队列。在研究结束时，已发现与80%分配到该剂量的参与者中他汀类药物依从性增加20%相关的干预剂量将被确定为MED。如果成功，当前试验将通过确定剂量（即，持续时间），以有意义地增加依从性。ClinicalTrials.gov NCT05273736。于2022年3月10日注册。https://www.clinicaltrials.gov/ct2/show/NCT05273736在线版本包含补充材料，可通过10.1186/s13063-023-07549-w获得。
In the USA, the primary cause of death and morbidity continues to be cardiovascular disease (CVD). Numerous trials have shown that statin medication reduces the likelihood of CVD events; it is a cornerstone of CVD prevention. However, studies have also indicated that up to 60% of the estimated 26.8 million Americans prescribed primary prevention statin treatment are nonadherent during the first year. Multi-component behavioral change technique (BCT) therapies have shown moderate promise in improving medication adherence as well as other positive health behaviors (such as physical activity). However, no research has looked at the duration of multi-component BCT intervention needed to result in a clinically significant improvement in statin adherence behaviors. This study aims to determine the necessary dose of a multi-component BCT intervention (defined as duration in weeks) to promote adherence to statin medication among those on primary prevention statin treatment by utilizing the modified time-to-event continuous reassessment method (TiTE-CRM). The study will utilize the modified TiTE-CRM in 42 participants, recruited in 14 cohorts of 3 participants each. The goal of this analysis is to identify the minimum effective dose (MED) of a multi-behavior change technique (BCT) intervention required to increase adherence to statins by 20% between baseline and follow-up periods. Using the TiTE-CRM method, the dose of the behavior intervention in weeks will be assigned to each cohort based on the performance of the prior cohort. At the end of the study, the intervention dose that has been found to be associated with a 20% increase in statin adherence among 80% of participants assigned to that dose will be identified as the MED. If successful, the current trial will provide additional guidance to researchers and clinicians seeking to increase statin medication adherence using a BCT intervention by identifying the dose (i.e., the duration) of an intervention required to meaningfully increase adherence. ClinicalTrials.gov NCT05273736. Registered on March 10, 2022. https://www.clinicaltrials.gov/ct2/show/NCT05273736 The online version contains supplementary material available at 10.1186/s13063-023-07549-w.
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