心血管疾病患者中运用行为经济学理论进行步数反馈（FOOTSTEPS）试验的原理与试验设计
Rationale and Trial Design of Feedbacks Using Behavioural Economic Theories on STEP Counts (FOOTSTEPS) Trial in Patients With Cardiovascular Disease.
作者信息
Suzuki Takahiro, Aoki Jiro, Abe Kohei, Asano Taku, Yoneoka Daisuke, Sato Shuntaro, Rewley Jeffrey, Miyata Kotaro, Ono Masafumi, Saito Akira, Kanie Takayoshi, Okui Kenta, Takahashi Akinari, Isa Koichiro, Takasago Satoshi, Shiina Yumi, Nishihata Yosuke, Niinuma Hiroyuki, Masuda Keita, Kijima Yasufumi, Nishida Hidefumi, Komiyama Nobuyuki, Sugibuchi Keiko, Suzuki Yoko, Igarashi Aoi, Suzumura Sachiko, Tsurugi Nanami, Okamura Daisuke, Mizuno Atsushi
机构信息
Department of Cardiovascular Medicine, St Luke's International Hospital, Tokyo, Japan.
Department of Public Health, Institute of Science Tokyo, Tokyo, Japan.
出版信息
CJC Open. 2024 Dec 27;7(4):535-544. doi: 10.1016/j.cjco.2024.12.009. eCollection 2025 Apr.
UNLABELLED
Physical activity is crucial for reducing cardiovascular disease (CVD) risk. Interventions for nonsupervised exercise therapy have not been broadly implemented, and few patients with CVD achieve the recommended activity levels (eg, 8000 daily steps). Behavioural economics-based programs increased physical activity in the general population; however, their effectiveness-including the impact of gain vs loss framing-in patients with CVD remains unclear. This study investigates the effectiveness of gamification with social incentives and support in promoting physical activity among patients with CVD using smartphone applications.This 5-arm, randomized controlled trial will recruit adult patients with CVD from a single acute tertiary emergency hospital in Tokyo, Japan. Participants will be randomly assigned to 1 of 5 groups: control, gamification (loss framing), gamification (gain framing), gamification (loss framing) + social support, or gamification (gain framing) + social support. The smartphone application incorporates gamification elements: points, rankings, and framing effects. Participants in social support arms will nominate a family member or friend to receive weekly progress reports and provide encouragement. The intervention period is 6 weeks, followed by a 6-week follow-up. The primary outcome is the change in mean daily step count from baseline to the intervention period. The target sample size is 325 participants (65 per arm), and mixed-effects regression models will be used to assess changes in physical activity.This trial will evaluate the effectiveness of gamification with social incentives and support to increase physical activity in patients with CVD. These findings may provide valuable evidence regarding the effectiveness of gamification systems in improving outcomes for this population.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov ID NCT06446076.
未标注
身体活动对于降低心血管疾病（CVD）风险至关重要。非监督式运动疗法的干预措施尚未广泛实施，很少有CVD患者达到推荐的活动水平（例如，每天8000步）。基于行为经济学的项目增加了普通人群的身体活动；然而，它们在CVD患者中的有效性，包括得失框架的影响，仍不清楚。本研究调查了使用智能手机应用程序，通过社交激励和支持进行游戏化，在促进CVD患者身体活动方面的有效性。
这项五臂随机对照试验将从日本东京的一家急性三级急诊医院招募成年CVD患者。参与者将被随机分配到五组中的一组：对照组、游戏化（损失框架）、游戏化（收益框架）、游戏化（损失框架）+社交支持，或游戏化（收益框架）+社交支持。智能手机应用程序包含游戏化元素：积分、排名和框架效应。社交支持组的参与者将提名一名家庭成员或朋友接收每周进展报告并提供鼓励。干预期为6周，随后是6周的随访。主要结局是从基线到干预期平均每日步数的变化。目标样本量为325名参与者（每组65名），将使用混合效应回归模型评估身体活动的变化。
本试验将评估通过社交激励和支持进行游戏化，以增加CVD患者身体活动的有效性。这些发现可能为游戏化系统在改善该人群结局方面的有效性提供有价值的证据。
试验注册号
ClinicalTrials.gov ID NCT06446076。
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