Feedback Using behaviOral econOmic Theories on STEP countS in Cardiovascular Disease Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 325
- 试验地点
- 2
- 主要终点
- Change in mean daily step counts
研究概览
简要总结
This is a prospective, randomized controlled trial. The aim of the study is to verify the effectiveness of interventions using gamification with social incentives and social support to increase physical activity in patients with CVD through randomized controlled trials.
详细描述
The three aims of this randomized controlled trials;
- To demonstrate the effectiveness of loss framing in gamification for achieving increased physical activity in patients with CVD.
- To demonstrate the effectiveness of social support in gamification for achieving increased physical activity in patients with CVD.
- To evaluate the impact of the intervention using social incentives and social support through gamification on changes in participants; subjective assessment of physical activity levels, body mass index (BMI), and lipid panel in blood tests.
Secondary Objective:
- To assess whether the differences between study groups in achieving the goal of increased physical activity during the 6-week intervention period persist during the 6-week follow-up period.
- To investigate how the increase in physical activity through gamification in patients with CVD is influenced by patients; behavioral characteristics and environmental factors.
This trial will be a five-group, randomized controlled trial (RCT) with an intervention period of 6 weeks and a follow-up period of additional 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •History of old myocardial infarction or chronic heart failure
- •Ability to read and provide informed consent to participate in this trial
- •Owning a smartphone capable of installing this application
排除标准
- •Having difficulty using smartphones (due to vision problems or IT literacy issues)
- •Exercise therapy is contraindicated (in accordance with the 2021 revised guidelines on rehabilitation in cardiovascular diseases)
- •Ability to read and provide informed consent to participate in this trial
- •Owning a smartphone capable of installing this application
- •Participating in other studies related to physical activity
- •Being pregnant
- •Any other medical conditions or reasons they are unable to participate in a physical activity study for 12 weeks
结局指标
主要结局
Change in mean daily step counts
时间窗: From enrollment to the end of intervention period at 8 weeks (2-weeks run-in and 6-weeks intervention period)
The primary outcome is change in mean daily step counts from baseline to the 6-week intervention period.
次要结局
- Percentage of days achieving their step goals(From enrollment to the end of follow-up period at 14 weeks)
研究者
Atsushi Mizuno
Director, Medical quality management office
St. Luke's International Hospital, Japan