- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03207646
Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Stanford, California, États-Unis, 94305
- Stanford Healthcare
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion criteria:
I. ≥ 18 years of age
II. Patient at Stanford Health Care with evidence of CAD (atherosclerosis of one or more coronary arteries or clinical evidence or documentation of ischemia, infarction) OR a diagnosis related to CAD (i.e. ischemic heart disease ICD-10-Code: I20-25).
III. Prescription of a P2Y12 antagonist and/or a statin for an anticipated duration of at least 3 months following discharge
IV. Possession of a compatible (iPhone 5s or later; OS 8.1 or higher) smartphone with an active phone number and data plan. The smartphone must be in continued possession of the participant. It may not be a shared device and must exclusively remain in the possession of the participant during the study period. The smartphone must have an active cellular phone number and cellular data subscription. Wi-Fi internet capability is not a substitute for an active cellular data plan.
V. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
VI. Willing to have the mobile application installed on a smartphone and use it every day during the entire study period VII. Willing to provide oral confirmation indicating that he/she is currently not using a medication adherence application.
VIII. Ability to read and understand English.
Exclusion criteria:
Any potential participant who meets any of the following criteria will be excluded from participating in the study:
I. Anticipated inability to adhere to the mobile application (BrightHeart®) based on opinion of site Principal Investigator (PI).
II. Current use of adherence tracking devices, electronic, smartphone or computer applications, including but not limited to smart pill bottles, pill timers, radiofrequency tagged medications or dispensers, mobile applications, or automated phone reminders. Pill organizers that remind participants when to take medicine with beeps or alerts are exclusion.
a. Note: Pharmacy and health care plan automated refill reminders are permitted and are not exclusion. Pill organizers or containers that only compartmentalize a participant's medications based on days of the week are not exclusion.
III. Cognitive, visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone. Co-morbidities that would preclude participation (e.g. ongoing chemotherapy) or planned hospitalization for complex procedures as determined by the PI (e.g. bypass, valve or aortic surgery, transarterial valve replacement) IV. End-stage of one of the following: heart failure (using left ventricular assist device or listed for heart transplantation), renal disease, lung disease, liver disease.
V. Any condition with a life expectancy less than 3 months. VI. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator VII. Any other condition as determined by the PI.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: smartphone-based cardiac rehabilitation
The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program.
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BrightHeart® has two components: smartphone mobile based application and a human coach.
It is a combined approach of medication adherence, exercise, diet, sleep and stress reduction.
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Aucune intervention: Control
Standard-of-care alone.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Medication adherence
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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The proportion of days coverd (PDC) expressed as a percentage but considered as a continuous variable of the composite of the prescribed P2Y12 receptor antagonist and/or the statin.
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Baseline through End of Study visit - approximately 90 days per participant.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Medication adherence II
Délai: Baseline through End of Study visit - approximately 90 days per participant.
|
Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin
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Baseline through End of Study visit - approximately 90 days per participant.
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Medication adherence III
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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The PDC of each medication of the composite
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Baseline through End of Study visit - approximately 90 days per participant.
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Medication adherence IV
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants with PDC ≥ 80% of each of the composite
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Baseline through End of Study visit - approximately 90 days per participant.
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Medication adherence V
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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Mean time from discharge to first fill
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Baseline through End of Study visit - approximately 90 days per participant.
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Medication persistence
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors I
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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Serum LDL-C at End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors II
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants within target blood pressure (<140/90 mmHg or <130/80 mmHg for patients with diabetes mellitus or chronic kidney disease) at End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors III
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)
|
Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors IV
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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Change in body weight from baseline to End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors V
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors VI
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors VII
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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Physical activity at End of Study (measured by a physical acitivity questionnaire)
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Baseline through End of Study visit - approximately 90 days per participant.
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Exploratory I: Rehospitalization
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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30-day rehospitalization for any reason
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Baseline through End of Study visit - approximately 90 days per participant.
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Exploratory II: Cardiovascular outcomes
Délai: Baseline through End of Study visit - approximately 90 days per participant.
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Major adverse cardiac events (MACE) defined as: Death, myocardial infarction, acute coronary syndrome, out of hospital cardiac arrest, stent thrombosis, repeat revascularization at 90 days
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Baseline through End of Study visit - approximately 90 days per participant.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Minang (Mintu) Turakhia, MD, Stanford University
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 39555
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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
produit fabriqué et exporté des États-Unis.
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 .
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