Clinical trial NCT06446076: Feedback Using behaviOral econOmic Theories on STEP countS in Cardiovascular Disease Patients
Official title: Feedback Using behaviOral econOmic Theories on STEP countS in Cardiovascular Disease Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Rehabilitation
Behavioral Economics
Keywords: Cardiovascular diseases
Rehabilitation
Behavioral Economics
Health Services
Lead sponsor: St. Luke's International Hospital, Japan
Sponsor class: OTHER
Collaborators: name: Trigen
First posted: 2024-06-06
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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 outcomes:
measure: Change in mean daily step counts
timeFrame: From enrollment to the end of intervention period at 8 weeks (2-weeks run-in and 6-weeks intervention period)
Secondary outcomes:
measure: Percentage of days achieving their step goals
timeFrame: From enrollment to the end of follow-up period at 14 weeks
Other outcomes:
measure: Change in International Physical Activity Questionnaire (IPAQ)
timeFrame: From enrollment to the end of follow-up period at 14 weeks
measure: Change in Body weight (BMI)
timeFrame: From enrollment to the end of follow-up period at 14 weeks
measure: Change in LDL/HDL cholesterol
timeFrame: From enrollment to the end of follow-up period at 14 weeks
Locations:
city: Tokyo
country: Japan
facility: St. Luke&#39;s International Hospital
Study officials:
affiliation: Department of Cardiovascular Medicine, St. Luke's International Hospital
name: Atsushi Mizuno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: