- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Isparta, Turquie (Türkiye)
- Suleyman Demirel University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Groupe de contrôle
|
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.
|
|
Expérimental: Avatar-based education group
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Coronary artery disease knowledge (CADE-Q II)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Health-related quality of life (HeartQoL)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- doi.org/10.1093/ehjdh/ztaf036
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- E.1043124
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .