Cash-Only INcentives to promote insulin DOSE engagement: A protocol paper for the pilot randomized controlled trial of COIN2DOSE.
Cash-Only INcentives to promote insulin DOSE engagement: A protocol paper for the pilot randomized controlled trial of COIN2DOSE.
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DOI：
10.1016/j.cct.2022.107008
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发表时间：
2022-12
影响因子：
2.2
通讯作者：
Clements, Mark A.
中科院分区：
文献类型：
--
作者：
Patton, Susana R.;Fox, Larry;Cushing, Christopher C.;McDonough, Ryan;Clements, Mark A.
大多数 1 型糖尿病 (T1D) 青少年的糖化血红蛋白 (HbA1c) 达不到 <7.0%，而这是当前的临床目标。移动医疗可以提供一种可扩展且适合年龄的行为干预方法，以降低青少年的 HbA1c 水平，同时应用既定的行为改变和行为经济学理论可以提高科学严谨性。我们的目标是对一种名为 Coin2Dose（促进胰岛素剂量参与的仅现金激励）的新型 mHealth 干预措施进行试点随机临床试验，以患有 T1D 的青少年为样本：1) 获得可行性和可接受性的衡量标准，2) 根据干预后和干预后 3 个月的青少年每日 BOLUS 评分、HbA1c 水平和范围时间 (TIR) 的差异，检查与标准护理对照组的初步疗效后续行动。该试点随机对照试验已在 ClinicalTrials.gov 中注册 (NCT#05280184)。我们的试点项目将招募 11-17 岁的 1D 青少年，他们使用胰岛素泵或蓝牙连接的胰岛素笔，并且平均每日 BOLUS 分数 <2.5。随机接受 Coin2Dose 治疗的青少年将接受 12 周的干预，然后是 12 周的维持期。该试点计划于 2022 年 7 月开始，并于 2025 年结束。试点结束时，我们将获得有关提高 BOLUS 分数的两种不同行为经济激励结构的可行性和可接受性的信息。预计这项工作将进展到最终功效试验。我们将通过在地方、国家和国际会议上的演讲以及经过同行评审的糖尿病和心理学期刊来传播研究结果。
Most adolescents with type 1 diabetes (T1D) do not achieve a glycated hemoglobin (HbA1c) <7.0%, which is the current clinical target. mHealth can offer a scalable and age-appropriate delivery method for behavioral interventions to lower adolescents’ HbA1c levels, while applying established behavior change and behavioral economics theories can enhance scientific rigor. We aim to conduct a pilot randomized clinical trial of a novel mHealth intervention called Coin2Dose (Cash-Only INcentives To promote insulin DOSE engagement), in a sample of youth with T1D: 1) to obtain measures of feasibility and acceptability and 2) to examine preliminary efficacy versus a standard care control group based on differences in youth’s daily BOLUS scores, HbA1c levels, and Time in Range (TIR) at post-intervention and 3-month post-intervention follow-up. This pilot RCT is already registered in ClinicalTrials.gov (NCT#05280184). Our pilot will recruit youth with T1D 11–17 years-old who use an insulin pump or Bluetooth connected insulin pen and have an average daily BOLUS score <2.5. Youth randomized to Coin2Dose will receive the intervention for 12 weeks followed by a 12-week maintenance period. The pilot is scheduled to start July 2022 and to conclude in 2025. At the conclusion of the pilot, we will have information about the feasibility and acceptability of two different behavioral economic incentive structures for improving BOLUS scores. The work is anticipated to progress to final efficacy trial. We will disseminate study results through presentations at local, national, and international conferences and through peer-reviewed diabetes and psychology journals.
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引入智能连接的胰岛素笔之后，范围内的时间增加了，错过的注射量很少。
影响因子：
5.4
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影响因子：
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影响因子：
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通讯作者：
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影响因子：
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作者：
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影响因子：
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