PDF(Pubmed)
Abstract：
Statin therapy is a mainstay of cardiovascular disease (CVD) prevention, but research shows that statin therapy alone is insufficient for preventing incident CVD and mortality. Combining statin medication with increased physical activity (PA) can lower mortality risk more than either statin or PA alone. However, PA levels often remain the same and may even decline following statin prescription. Additional information is needed to identify how to increase PA among statin users and determine the minimal length of an intervention (i.e., intervention dose) necessary to increase PA.
The study aims to identify the required dose of a behavior change technique (BCT) intervention to increase PA among individuals on primary prevention statin therapy who have an elevated risk for cardiovascular disease (CVD).
The study will utilize the modified time-to-event continual reassessment method (TiTE-CRM) in 42 participants. We expect insights relating to dose-efficacy models and BCTs (Behavior Change Techniques) to improve PA in adults at risk for CVD. This trial will also examine potential mechanisms of action (MoAs) for interventions to increase PA, identify any effect a PA intervention may have on medication adherence, and determine whether participants respond uniformly to their respective behavioral interventions.
This trial was approved by the Northwell Health Institutional Review Board (IRB) and all participants will complete informed consent. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalized trials will follow the CONSORT reporting guidelines.
This trial is registered on www.
gov (Number NCT05273723).
The study aims to identify the required dose of a behavior change technique (BCT) intervention to increase PA among individuals on primary prevention statin therapy who have an elevated risk for cardiovascular disease (CVD).
The study will utilize the modified time-to-event continual reassessment method (TiTE-CRM) in 42 participants. We expect insights relating to dose-efficacy models and BCTs (Behavior Change Techniques) to improve PA in adults at risk for CVD. This trial will also examine potential mechanisms of action (MoAs) for interventions to increase PA, identify any effect a PA intervention may have on medication adherence, and determine whether participants respond uniformly to their respective behavioral interventions.
This trial was approved by the Northwell Health Institutional Review Board (IRB) and all participants will complete informed consent. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalized trials will follow the CONSORT reporting guidelines.
This trial is registered on www.
gov (Number NCT05273723).
摘要：
背景：他汀类药物治疗是心血管疾病（CVD）预防的主要手段，但研究表明,单独的他汀类药物治疗不足以预防心血管事件和死亡率.与单独使用他汀类药物或PA相比，将他汀类药物与增加的体力活动（PA）结合使用可以降低死亡率。然而,PA水平通常保持不变，甚至可能在他汀类药物处方后下降。需要额外的信息来确定如何在他汀类药物使用者中增加PA并确定干预的最小长度(即，干预剂量）增加PA所必需的。
目的：该研究旨在确定行为改变技术（BCT）干预所需的剂量，以增加接受一级预防他汀类药物治疗的心血管疾病（CVD）风险升高的个体的PA。
方法：该研究将在42名参与者中使用改进的事件发生时间连续重新评估方法（TiTE-CRM）。我们期望与剂量-功效模型和BCT（行为改变技术）相关的见解可以改善有CVD风险的成年人的PA。该试验还将研究增加PA的干预措施的潜在作用机制（MoAs）。确定PA干预可能对药物依从性产生的任何影响，并确定参与者是否对各自的行为干预反应一致。
背景：该试验获得了Northwell卫生机构审查委员会（IRB）的批准，所有参与者都将完成知情同意。试验结果将发表在同行评审的期刊上。本系列个性化试验产生的所有出版物将遵循CONSORT报告指南。
背景：此试验已在www上注册。
结果：gov（编号NCT05273723）。
目的：该研究旨在确定行为改变技术（BCT）干预所需的剂量，以增加接受一级预防他汀类药物治疗的心血管疾病（CVD）风险升高的个体的PA。
方法：该研究将在42名参与者中使用改进的事件发生时间连续重新评估方法（TiTE-CRM）。我们期望与剂量-功效模型和BCT（行为改变技术）相关的见解可以改善有CVD风险的成年人的PA。该试验还将研究增加PA的干预措施的潜在作用机制（MoAs）。确定PA干预可能对药物依从性产生的任何影响，并确定参与者是否对各自的行为干预反应一致。
背景：该试验获得了Northwell卫生机构审查委员会（IRB）的批准，所有参与者都将完成知情同意。试验结果将发表在同行评审的期刊上。本系列个性化试验产生的所有出版物将遵循CONSORT报告指南。
背景：此试验已在www上注册。
结果：gov（编号NCT05273723）。
