Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
BMJ Open. 2021 Nov 24;11(11):e055930. doi: 10.1136/bmjopen-2021-055930.
Medication adherence for patients with chronic conditions such as gout, a debilitating form of arthritis that requires daily medication to prevent flares, is a costly problem. Existing interventions to improve medication adherence have only been moderately effective. Habit formation theory is a promising strategy to improve adherence. The cue-reward-repetition principle posits that habits are formed by repeatedly completing an activity after the same cue and having the action rewarded every time. Over time, cues become increasingly important whereas rewards become less salient because the action becomes automatic. Leveraging the cue-reward-repetition principle could improve adherence to daily gout medications.
This three-arm parallel randomised controlled trial tests an adaptive intervention that leverages the repetition cue-reward principle. The trial will began recruitment in August 2021 in Boston, Massachusetts, USA. Eligible patients are adults with gout who have been prescribed a daily oral medication for gout and whose most recent uric acid is above 6 mg/dL. Participants will be randomised to one of three arms and given electronic pill bottles. In the two intervention arms, participants will select a daily activity to link to their medication-taking (cue) and a charity to which money will be donated every time they take their medication (reward). Participants in Arm 1 will receive reminder texts about their cue and their charity reward amount will be US$0.50 per day of medication taken. Arm 2 will be adaptive; participants will receive a US$0.25 per adherent-day and no reminder texts. If their adherence is <75% 6 weeks postrandomisation, their reward will increase to US$0.50 per adherent-day and they will receive reminder texts. The primary outcome is adherence to gout medications over 18 weeks.
This trial has ethical approval in the USA. Results will be published in a publicly accessible peer-reviewed journal.
NCT04776161.
对于患有慢性疾病（如痛风）的患者来说，坚持药物治疗是一个代价高昂的问题，痛风是一种会导致身体残疾的关节炎，需要每天服药以预防病情发作。目前，改善药物治疗依从性的干预措施效果有限。习惯形成理论是一种提高依从性的很有前途的策略。线索-奖励-重复原则认为，习惯是通过在相同线索后反复完成同一活动，并在每次行动时得到奖励而形成的。随着时间的推移，线索变得越来越重要，而奖励则变得不那么重要，因为行动变得自动了。利用线索-奖励-重复原则可以提高每日痛风药物的依从性。
这项三臂平行随机对照试验测试了一种利用重复线索-奖励原则的适应性干预措施。该试验于 2021 年 8 月在美国马萨诸塞州波士顿开始招募。符合条件的患者是被开处每日口服痛风药物且最近尿酸水平高于 6mg/dL 的痛风患者。参与者将被随机分配到三个组中的一个，并获得电子药瓶。在两个干预组中，参与者将选择一项日常活动与他们的服药（线索）联系起来，并为每次服药时向他们选择的慈善机构捐赠一定金额的钱（奖励）。组 1 的参与者将收到关于他们的线索和慈善奖励金额的提醒短信，每天服药的奖励金额为 0.50 美元。组 2 将是自适应的；参与者将获得 0.25 美元/依从日的奖励，且不会收到提醒短信。如果他们在随机分组后 6 周的依从率<75%，他们的奖励将增加到 0.50 美元/依从日，并收到提醒短信。主要结果是 18 周内痛风药物的依从性。
这项试验在美国获得了伦理批准。结果将发表在公开获取的同行评议期刊上。
NCT04776161。
