Feinstein Institutes for Medical Research, Institute of Health System Science, Northwell Health, Manhasset, 130 East 59th Street, Suite 14C, New York, NY, 10022, USA.
Gordon F. Derner School of Psychology, Adelphi University, Garden City, NY, USA.
Trials. 2023 Aug 12;24(1):523. doi: 10.1186/s13063-023-07549-w.
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.
gov/ct2/show/NCT05273736.
在美国，主要的死亡和发病原因仍然是心血管疾病（CVD）。大量试验表明，他汀类药物可降低 CVD 事件的发生几率，是 CVD 预防的基石。然而，研究也表明，估计有 2680 万接受一级预防他汀类药物治疗的美国人中，多达 60%的人在第一年不遵医嘱。多成分行为改变技术（BCT）疗法在提高药物依从性以及其他积极的健康行为（如体育活动）方面显示出了一定的前景。然而，目前还没有研究关注多成分 BCT 干预所需的持续时间，以改善他汀类药物治疗的依从性。本研究旨在利用改良的时间事件连续评估法（TiTE-CRM），确定多成分 BCT 干预（定义为干预周数）的必要剂量，以提高一级预防他汀类药物治疗人群的他汀类药物依从性。
本研究将在 42 名参与者中利用改良的 TiTE-CRM 进行，这些参与者将被分为 14 个 3 人小组。本分析的目标是确定增加他汀类药物依从性 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，根据前一组的表现，将行为干预的周数剂量分配给每个小组。在研究结束时，将确定被分配到该剂量的 80%的参与者中有 20%的人增加了他汀类药物依从性的剂量，该剂量将被认为是 MED。
如果成功，该试验将为研究人员和临床医生提供更多的指导，以通过 BCT 干预来提高他汀类药物的依从性，确定增加依从性所需的干预剂量（即持续时间）。
ClinicalTrials.gov NCT05273736。注册于 2022 年 3 月 10 日。https://www.clinicaltrials.gov/ct2/show/NCT05273736.
NCT05273736。
