The effect of a multi-component behavior change technique intervention on medication adherence among individuals on primary prevention statin therapy: a dose-finding protocol

Trials

Study Protocol

Patrick Robles¹  Mark J. Butler¹  Jerry M. Suls¹  Ciaran P. Friel¹  Frank Vicari¹  Elizabeth A. Vrany¹  Thevaa Chandereng¹  Karina W. Davidson²  Anne-Marie N. Romain³  Rumisha Augustin⁴  Ying Kuen Cheung⁵ 

[1] Feinstein Institutes for Medical Research, Institute of Health System Science, Northwell Health, Manhasset, 130 East 59th Street, Suite 14C, 10022, New York, NY, USA;Feinstein Institutes for Medical Research, Institute of Health System Science, Northwell Health, Manhasset, 130 East 59th Street, Suite 14C, 10022, New York, NY, USA;Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, NY, USA;Feinstein Institutes for Medical Research, Institute of Health System Science, Northwell Health, Manhasset, 130 East 59th Street, Suite 14C, 10022, New York, NY, USA;Gordon F. Derner School of Psychology, Adelphi University, Garden City, NY, USA;Feinstein Institutes for Medical Research, Institute of Health System Science, Northwell Health, Manhasset, 130 East 59th Street, Suite 14C, 10022, New York, NY, USA;Temple University School of Pharmacy, Temple University, Philadelphia, PA, USA;Mailman School of Public Health, Columbia University, New York, NY, USA;

关键词: Adherence;    Behavioral change techniques (BCT);    Cardiovascular disease (CVD);    Cholesterol;    Dose finding;    Personalized;    Personalized trial;    Statin;   

DOI  :  10.1186/s13063-023-07549-w

 received in 2023-03-10, accepted in 2023-07-26,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundIn 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 and designThe 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.DiscussionIf 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.Trial registrationClinicalTrials.gov NCT05273736. Registered on March 10, 2022. https://www.clinicaltrials.gov/ct2/show/NCT05273736

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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