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Active, not recruiting Not applicable

Feedback Using behaviOral econOmic Theories on STEP countS in Cardiovascular Disease Patients

NCT06446076 · tracked via the Priya Life Science Japan tracker
Sponsor
St. Luke's International Hospital, Japan
Phase
Not applicable
Started
2024-06-12
Last updated
2025-05-15

Condition(s) studied

Cardiovascular DiseasesRehabilitationBehavioral Economics

Investigational drug(s) / intervention(s)

Gamification (Gain/Loss framing)Social support

Gamification (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.

Social 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
St. Luke's International Hospital Tokyo Tokyo
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06446076 on ClinicalTrials.gov ↗ ← All trials in Japan