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

St. Luke's International Hospital, Japan

Status: Active, not recruiting

Conditions: Rehabilitation; Cardiovascular Diseases; Behavioral Economics

Treatments: Behavioral: Social support; Behavioral: Gamification (Gain/Loss framing)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06446076

23-RCK043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 325 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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325 participants in 5 patient groups

Control group

No Intervention group

Description:

Participants in this group will not receive goal-setting or gamification interventions during the 6-week intervention period and the additional 6-week follow-up period. As an "active control" during the 12-week trial period, participants will be able to check their daily step counts using an application with the same specifications.

Gamification (Loss framing)

Experimental group

Description:

This group will receive a gamification intervention with loss framing.

Treatment:

Behavioral: Gamification (Gain/Loss framing)

Gamification (Gain framing)

Experimental group

Description:

This group will receive a gamification intervention with gain framing.

Treatment:

Behavioral: Gamification (Gain/Loss framing)

Gamification (Loss framing) + Social support

Experimental group

Description:

This group will receive a gamification intervention with loss framing and a social support intervention.

Treatment:

Behavioral: Gamification (Gain/Loss framing)

Behavioral: Social support

Gamification (Gain framing) + Social support

Experimental group

Description:

This group will receive a gamification intervention with gain framing and a social support intervention.

Treatment:

Behavioral: Gamification (Gain/Loss framing)

Behavioral: Social support