Behavioral Economics, Cardiovascular Diseases, Rehabilitation
Conditions
Keywords
Cardiovascular diseases, Rehabilitation, Behavioral Economics, Health Services
Brief summary
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.
Detailed description
The three aims of this randomized controlled trials; 1. To demonstrate the effectiveness of loss framing in gamification for achieving increased physical activity in patients with CVD. 2. To demonstrate the effectiveness of social support in gamification for achieving increased physical activity in patients with CVD. 3. 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: 1. 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. 2. 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.
Interventions
BEHAVIORALGamification (Gain/Loss framing)
Participants will take part in a 6-week game-based program designed to help them reach their daily step goals. They are encouraged to maintain their daily step counts to achieve their daily step target over the 6-week intervention period. The gamification design incorporates two theoretically effective behavioral economics principles, Fresh Start and Loss Aversion. All participants start from the Silver rank (middle rank), and their rank changes based on each final point of the week. The ranks are set from top to bottom as Platinum, Gold, Silver, Bronze, and Blue. In loss framing, if the daily step target is 6000 steps, maintaining 70 points for achieving 6000 steps on day 1, and a deduction of 10 points for not achieving it. In gain framing, achieving 6000 steps on day 1 results in an addition of 10 points, with no increase for not achieving it. After one week, ranks increase if the points at midnight on Sunday are 40 or above, and decrease if below this threshold.
BEHAVIORALSocial support
Participants in this group are asked to designate a family member or friend to provide social support. This supporter is encouraged to check the participant's progress and provide support during the interventional period. The supporter will also receive weekly emails throughout the period, informing them about the participant's daily step counts, achievement status, points, levels, and other relevant information.
Sponsors
Trigen
St. Luke's International Hospital, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean daily step counts | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of days achieving their step goals | From enrollment to the end of follow-up period at 14 weeks | Secondary outcomes include the percentage of days achieving their step goals during the intervention and follow-up periods and the change in daily step counts from baseline to follow-up period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in International Physical Activity Questionnaire (IPAQ) | From enrollment to the end of follow-up period at 14 weeks | Change in the participant's subjective assessment of physical activity level measured using the International Physical Activity Questionnaire (IPAQ) Short Form. This is a survey that investigates how individuals engage in physical activity (how they move their bodies) in their daily lives. It is a questionnaire that assesses the duration and frequency of exercise based on intensity levels. |
| Change in Body weight (BMI) | From enrollment to the end of follow-up period at 14 weeks | Change in body weight (BMI) (kg/m\^2) |
| Change in LDL/HDL cholesterol | From enrollment to the end of follow-up period at 14 weeks | Change in LDL/HDL cholesterol (mg/dL) |
Countries
Japan
Outcome results
None listed