- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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)
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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California
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Stanford, California, Stati Uniti, 94305
- Stanford Healthcare
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
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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Nessun intervento: Control
Standard-of-care alone.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Medication adherence
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
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.
|
Baseline through End of Study visit - approximately 90 days per participant.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Medication adherence II
Lasso di tempo: 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
|
Baseline through End of Study visit - approximately 90 days per participant.
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Medication adherence III
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
The PDC of each medication of the composite
|
Baseline through End of Study visit - approximately 90 days per participant.
|
Medication adherence IV
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
Proportion of participants with PDC ≥ 80% of each of the composite
|
Baseline through End of Study visit - approximately 90 days per participant.
|
Medication adherence V
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
Mean time from discharge to first fill
|
Baseline through End of Study visit - approximately 90 days per participant.
|
Medication persistence
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
|
Baseline through End of Study visit - approximately 90 days per participant.
|
Cardiovascular risk factors I
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
Serum LDL-C at End of Study
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Baseline through End of Study visit - approximately 90 days per participant.
|
Cardiovascular risk factors II
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
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
|
Baseline through End of Study visit - approximately 90 days per participant.
|
Cardiovascular risk factors III
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
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.
|
Cardiovascular risk factors IV
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
Change in body weight from baseline to End of Study
|
Baseline through End of Study visit - approximately 90 days per participant.
|
Cardiovascular risk factors V
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
|
Baseline through End of Study visit - approximately 90 days per participant.
|
Cardiovascular risk factors VI
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
|
Baseline through End of Study visit - approximately 90 days per participant.
|
Cardiovascular risk factors VII
Lasso di tempo: Baseline through End of Study visit - approximately 90 days per participant.
|
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
Lasso di tempo: 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
Lasso di tempo: 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
|
Baseline through End of Study visit - approximately 90 days per participant.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Minang (Mintu) Turakhia, MD, Stanford University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 39555
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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