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临床试验/NCT04458766
NCT04458766已完成不适用

The Use of Mobile Health Technology and Behavioral Economics to Encourage Adherence to Statins in Adolescents With Familial Hypercholesterolemia

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
1.1: Baseline adherence level

研究概览

简要总结

Familial hypercholesterolemia (FH) affects over one million Americans and increases the risk of cardiovascular disease (CVD) by as much as 20-fold. Although the use of statins can substantially reduce this risk, adherence to statins in adults and adolescence is poor. In adults, lower rates of adherence are associated with an increased rate of CVD events and all-cause mortality, as well as an additional $44 billion annually in health care costs. Novel interventions are needed to improve medication adherence in patients with FH, starting in adolescents. An underused strategy to improve medication adherence incorporates the principles of behavioral economics. Traditional economic theory suggests that providing an incentive to perform a behavior will increase the frequency of that behavior. However, two prominent theories in behavioral economics, Present Bias and Loss Aversion, suggest that not all types of incentives are effective and that poorly structured incentives can actually be negative enforcers. With novel mobile health technologies (mHealth), interventions based on behavioral economics can now be studied on a larger scale. In this proposal, the investigators will test the use of monetary incentives ($30 per 30 days) to improve medication adherence in eligible subjects. The investigators will test the subject's adherence prior to the use of incentives (using the Morisky Medication Adherence Scale and the Wellth Mobile Application) and during the period of time the incentives are provided. Lastly, the investigators will test the subject's adherence (using the Morisky Medication Adherence Scale and Wellth App) during the 60 days following discontinuation of the incentives to determine if any effect of the incentive persists after the incentive is discontinued.

详细描述

Preventing cardiovascular disease (CVD) in children and adolescents depend partly on the efficacy of the patients' self-management of their disease between clinic visits. One example of a health behavior that is particularly important for patients with CVD is medication adherence. Although the development of statins provides an opportunity to substantially reduce this risk of CVD, adherence to statins in both adults and adolescents is frequently inadequate. In recent study of youth prescribed a statin using claims data, nearly 75% of adolescents have at least one 90-day period of nonadherence. In adults, statin nonadherence is often as low as 50% and is associated with an increased risk for of CVD events and all-cause mortality, as well as almost $44 billion annually in additional health care costs. Unfortunately, successful interventions to improve statin adherence in adults are rare and there are no formally tested interventions to improve statin adherence in adolescents.

It is critical novel interventions are developed that address medication adherence in adolescents with chronic diseases that increase the risk of CVD. Studies in adolescents with other diseases demonstrate that they appear to be particularly vulnerable to nonadherence across a wide-variety of conditions, including in adolescents with solid organ transplants and diabetes mellitus. Unfortunately, previous studies using text messaging reminders to take a medication or computerized action plans have not consistently shown positive results. Therefore, the significance of this proposal is that I will pilot a novel mobile health (mHealth) intervention that incorporates two theories in behavioral economics, Present Bias and Loss Aversion, to develop a better understanding of barriers to medication adherence in adolescents with cardiovascular risk factors.

Traditional economic theory suggests that providing individuals with incentives to complete an action will lead to increased frequency of the occurrence of the desired action. However, behavioral economics studies in adult populations suggest that not all incentive structures are effective and that some incentives may act like negative enforcers. Studies suggest that patients are biased towards the present and often discount future risks, which is termed Present Bias. For instance, studies of Present Bias suggest that even small rewards, if provided frequently and immediately after a participant completes a desired task can improve adherence in adults. This strategy can be improved by using the principles of Loss Aversion, which suggest that individuals place more value on money or objects that they have than on new objects of the same value. Therefore, incentives framed as a loss can be more powerful than if it is framed as a gain. Unfortunately, only a few studies in adolescents have incorporated behavioral economics into interventions aimed at behavior change. One promising study in youth with type 1 diabetes mellitus found behavioral economics approaches could influence adherence to insulin regimens and glucose monitoring. Whereas diabetes mellitus is symptomatic if not properly managed, statins typically are used as primary prevention in asymptomatic patients with familial hypercholesterolemia (FH), which may require unique incentive structures. Although monetary incentives have been used with varying degrees of success in adults, it is unclear if these findings translate to adolescents. Adolescents may discount future events more, have different attitudes towards health, and have less mature cognitive function and capacities than adults. In addition, interventions that improve medication adherence are often resource intensive, which decreases the likelihood of larger scale implementation. Using an mHealth application may reduce costs by automating processes previously requiring human time and resources. Further, an mHealth intervention may be more successful as it uses a medium that is ubiquitous in adolescence. For instance, mobile applications that use gamification have demonstrated that adolescents find these health applications engaging and that they are interested in using mHealth in the management of their disease across a diverse set of socioeconomic and cultural backgrounds. As many health behaviors track into adulthood, establishing healthy behaviors early is crucial, which requires using developmentally appropriate interventions to promote adherence and ultimately minimize the risk of CVD.

APPROACH Determine the efficacy of a monetary incentive to improve medication adherence. Aim 1.1 The investigators will determine the baseline adherence level in adolescents with FH prescribed a statin using the Morisky Medication Adherence Scale (MMAS).

Aim 1.2 The investigators will determine the efficacy of a monetary incentive on medication adherence. Patients who are found to have low adherence according to the MMAS in Aim 1.1 will be enrolled into an intervention using the Wellth® mobile health application (Wellth App).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of FH based on National Lipid Association (NLA) criteria and/or genetic testing
  • Prescribed a statin
  • Be able to provide written, informed consent or have a parent/guardian provide written, informed consent
  • Be able to use a mobile phone and application
  • Morisky Medication Adherence Scale score of ≤ 6

排除标准

  • Diagnosis of Homozygous FH
  • Residence in a long-term care facility where medications are administered
  • May become pregnant
  • History of adverse effect or allergy to a statin, or any ingredient in a statin

结局指标

主要结局

1.1: Baseline adherence level

时间窗: Day 0

Baseline adherence level to determine eligibility of subjects

1.2: Change in adherence with monetary incentives

时间窗: Days 14-74

Change in statin adherence in enrolled subjects following an intervention that includes access to the Wellth mobile phone application with reminders to take their medication, and will receive monetary incentives for taking medication as prescribed.

1.3: Change in adherence withOUT monetary incentives

时间窗: Days 75-134

Change in statin adherence in enrolled subjects following an intervention that includes access to the Wellth application with reminders to take their medication, but with no monetary incentives.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Hartz

Staff Cardiologist and Instructor of Pediatrics

Boston Children's Hospital

研究点 (2)

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