PDF(Pubmed)
Abstract：
BACKGROUND: 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).
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT05273736. Registered on March 10, 2022. https://www.
RESULTS: gov/ct2/show/NCT05273736.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT05273736. Registered on March 10, 2022. https://www.
RESULTS: gov/ct2/show/NCT05273736.
摘要：
背景：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，他汀类药物可降低CVD事件的可能性；它是预防CVD的基石。然而,研究还表明,估计有2680万美国人开出的一级预防他汀类药物治疗的第一年中,高达60%是不依从的.多组分行为改变技术（BCT）疗法在改善药物依从性以及其他积极的健康行为（例如身体活动）方面显示出适度的希望。然而,目前还没有研究对导致他汀类药物依从性行为临床显著改善所需的多组分BCT干预持续时间进行研究.本研究旨在确定多组分BCT干预的必要剂量（定义为以周为单位的持续时间），以通过使用改良的事件发生时间连续重新评估方法（TiTE-CRM）来促进对一级预防他汀类药物治疗的患者对他汀类药物的依从性。
方法：该研究将在42名参与者中使用改良的TiTE-CRM，招募了14个队列，每个队列3名参与者。该分析的目的是确定在基线和随访期间将他汀类药物的依从性提高20％所需的多行为改变技术（BCT）干预的最小有效剂量（MED）。使用TiTE-CRM方法，行为干预的剂量(周)将根据先前队列的表现分配给每个队列.在研究结束时,在80%的参与者中,发现与他汀类药物依从性增加20%相关的干预剂量将被确定为MED.
结论：如果成功，当前的试验将为寻求通过确定剂量来使用BCT干预来提高他汀类药物药物依从性的研究人员和临床医生提供额外的指导(即，持续时间)有意义地增加依从性所需的干预。
背景：ClinicalTrials.govNCT05273736。2022年3月10日注册。https://www.
结果：gov/ct2/show/NCT05273736。
方法：该研究将在42名参与者中使用改良的TiTE-CRM，招募了14个队列，每个队列3名参与者。该分析的目的是确定在基线和随访期间将他汀类药物的依从性提高20％所需的多行为改变技术（BCT）干预的最小有效剂量（MED）。使用TiTE-CRM方法，行为干预的剂量(周)将根据先前队列的表现分配给每个队列.在研究结束时,在80%的参与者中,发现与他汀类药物依从性增加20%相关的干预剂量将被确定为MED.
结论：如果成功，当前的试验将为寻求通过确定剂量来使用BCT干预来提高他汀类药物药物依从性的研究人员和临床医生提供额外的指导(即，持续时间)有意义地增加依从性所需的干预。
背景：ClinicalTrials.govNCT05273736。2022年3月10日注册。https://www.
结果：gov/ct2/show/NCT05273736。
