文章基本信息

标题：TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a randomized controlled trial using wireless technology and incentives
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作者：Robyn Su May Lim ; Daphne Su Lyn Gardner ; Yong Mong Bee 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2019
卷号：20
期号：1
页码：1-16
DOI：10.1186/s13063-019-3749-x
出版社：BioMed Central
摘要：Abstract Background The outcomes for those with type 2 diabetes mellitus (T2DM) in Singapore are poor. In this TRIal to slow the Progression Of Diabetes (TRIPOD), we will evaluate the effectiveness and cost-effectiveness of a comprehensive diabetes management package (DMP), with or without a financial incentives program, M-POWER Rewards, in efforts to improve HbA 1c levels for individuals with T2DM. Methods/design TRIPOD is a randomized, open-label, controlled, multi-center, superiority trial with three parallel arms: (1) usual care only, (2) usual care with DMP, and (3) usual care with DMP plus M-POWER Rewards. A total of 339 adults with sub-optimally controlled T2DM (self-reported HbA 1c 7.5–11.0%) will be block randomized according to a 1:1:1 allocation ratio to the three arms. The primary outcome is mean change in HbA 1c level at Month 12 from baseline. Secondary outcomes include mean change in HbA 1c level at Months 6, 18, and 24; mean changes at Months 6, 12, 18, and 24 in weight, blood pressure, and self-reported physical activity, weight monitoring, blood glucose monitoring, medication adherence, diabetes self-management, sleep quality, work productivity and daily activity impairment, and health utility index; and proportion of participants initiating insulin treatment by Months 6, 12, 18, and 24. Incremental cost-effectiveness ratios will be computed based on costs per improvement in HbA 1c at Month 12 and converted to cost per quality-adjusted life year gained. Discussion The TRIPOD study will present insights about the long-term cost-effectiveness and financial viability of the interventions and the potential for integrating within usual care. Trial registration ClinicalTrials.gov, NCT03800680 . Registered on 11 January 2019.
关键词：Diabetes; Smartphone apps; mHealth; Behavior change; Physical activity; Weight monitoring; Blood glucose monitoring; Medication adherence; Financial incentive