- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07704827
Avatar-Based Serious Game for Cardiac Rehabilitation After Heart Attack
Effectiveness of an Avatar-Based Serious Game in Facilitating Transition to Cardiac Rehabilitation After Myocardial Infarction: A Randomized Controlled Trial
This study looks at whether a tablet-based education game helps people recover better after a heart attack. When people leave the hospital after a heart attack, they are usually given advice about their medicines, follow-up visits, cardiac rehabilitation, and warning signs to watch for. Many people find it hard to remember all of this information later at home.
In this study, adults who were treated in hospital for a heart attack were divided by chance into two groups. One group received the usual face-to-face education before going home. The other group used an interactive avatar-based education game on a tablet, in which a guide character walks the patient through the same topics. The game could also be used at home for one month after discharge.
The researchers measured how much patients knew about their heart disease, their quality of life, whether they attended cardiac rehabilitation, and whether they were readmitted to hospital. These were checked before discharge and again at 1, 3, and 6 months. The goal is to learn whether the avatar-based game helps patients understand and manage their condition better than usual education.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Isparta, Turkey (Türkiye)
- Suleyman Demirel University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Confirmed ST-elevation or non-ST-elevation myocardial infarction during the current admission or within the preceding three months, including patients readmitted for revascularization (percutaneous coronary intervention or coronary artery bypass grafting)
- Planned discharge to home
- Able to operate a tablet computer or a smart phone
- Provided written informed consent
Exclusion Criteria:
- Insufficient Turkish-language proficiency to engage with the application or study procedures
- Severe comorbidity precluding engagement in lifestyle behaviour change or exercise
- Significant cognitive or visual impairment
- Concurrent enrolment in another interventional study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
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Standard face-to-face discharge education delivered individually by the principal investigator before discharge, covering medication management, personal health record keeping, follow-up continuity and cardiac rehabilitation, and recognition of warning signs.
|
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Experimental: Avatar-based education group
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Tablet-based, avatar-guided discharge education application structured around Coleman's Care Transitions Intervention model (medication management, personal health record, follow-up continuity, and recognition of warning signs), delivered through interactive, persona-adapted, scenario-based gameplay before discharge and accessible for one month afterwards.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coronary artery disease knowledge (CADE-Q II)
Time Frame: Post-intervention and at 1, 3, and 6 months after discharge
|
Disease-related knowledge measured with the Coronary Artery Disease Education Questionnaire II (CADE-Q II), a 31-item instrument scored 0-93, with higher scores indicating greater knowledge.
|
Post-intervention and at 1, 3, and 6 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life (HeartQoL)
Time Frame: Post-intervention and at 1, 3, and 6 months after discharge
|
Disease-specific health-related quality of life measured with the HeartQoL questionnaire (14 items, total score 0-42), with higher scores indicating better quality of life.
|
Post-intervention and at 1, 3, and 6 months after discharge
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- doi.org/10.1093/ehjdh/ztaf036
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E.1043124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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