Rosuvastatin Adherence App Study in China (eHELP China)
31 de agosto de 2018 actualizado por: AstraZeneca
A Randomized, Two-arm, Open, 24-week Study to Evaluate the Effect of a Smart Phone-based Patient Support Tool on Duration of Treatment in Patients Prescribed Rosuvastatin in China
This is a randomized, two-arm, open label, Phase IV clinical trial to evaluate if the provision of a smart phone-based patient support tool prolongs the patient's rosuvastatin treatment duration.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomised, two-arm, open, Phase IV clinical trial to evaluate if the provision of a smart phone-based patient support tool prolongs the patient's rosuvastatin treatment duration.
Patients diagnosed with dyslipidemia or hyperlipidemia at high risk and are treated with rosuvastatin will be offered participation in the study. Patients who accept and sign the Informed Consent will be randomised into one of two study groups:
- Active group: In this group, patients will have access to the smart phone-based patient support tool. The smart phone application used on the patients' smart phones will contain both the patient support tool and the questions for the clinical evaluation in the form of the Rosuvastatin Adherence questionnaire (RAQ), Beliefs about Medicine Questionnaire - General (BMQ-G), and a Lifestyle questionnaire (LSQ) on disease understanding, lifestyle and treatment awareness. Patients in the Active group will also receive feedback on their daily rosuvastatin treatment as entered in the patient support tool.
- Control group: In this group the patients will have no additional support beyond the commonly practiced patient information, i.e. the patients will have no access to the smart phone-based patient support tool. However, a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ).
In this study, no rosuvastatin will be dispensed to the study participants i.e. patients will purchase their rosuvastatin prescription themselves as in normal practice. All assessments in this study (including blood sampling for the lipid profile) will not be used for guiding the treatment of patients in the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
885
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing, Porcelana, 100730
- Research Site
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Beijing, Porcelana, 100034
- Research Site
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Beijing, Porcelana, 100029
- Research Site
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Beijing, Porcelana, 100191
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Beijing, Porcelana, 100049
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Beijing, Porcelana, 100045
- Research Site
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Beijing, Porcelana, 100700
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Beijing, Porcelana, 101199
- Research Site
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Changsha, Porcelana, 410005
- Research Site
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Chengdu, Porcelana, 610041
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Chongqing, Porcelana, 400013
- Research Site
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Hang Zhou, Porcelana, 310003
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Huzhou, Porcelana, 313003
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Nanchang, Porcelana, 330009
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Shandong, Porcelana, 262700
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Shanghai, Porcelana, 200072
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Shanghai, Porcelana, 201199
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Shanghai, Porcelana, 200240
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Shanghai, Porcelana, 200050
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Tianjin, Porcelana, 300142
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Tianjin, Porcelana, 300211
- Research Site
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Tianjin, Porcelana, 300192
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Waifang, Porcelana, 261500
- Research Site
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Wenzhou, Porcelana, 325000
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Wuhan, Porcelana, 430022
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Female or male aged 18-80 years, diagnosed with dyslipidemia or hyperlipidemia at high risk and prescribed rosuvastatin
Dyslipidemia or hyperlipidemia defined as:
LDL-C≥2.6 mmol/L and TG<4.52mmol/L
High risk complies with any of the following:
- Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS), coronary revascularization [percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)] and other arterial revascularization procedures, ischaemic stroke and peripheral arterial disease (PAD).
- Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria).
Patients with moderate to severe chronic kidney disease [(CKD), glomerular filtration rate (GFR) < 60 mL/min/1.73 m2].
- Patients must have a smart phone that is compatible with the patient support tool and clinical evaluation questionnaire at their disposal and are comfortable with using of interactive smart phone applications. The required specification for the phone will be determined after completed testing.
- Ability to read, understand and write Chinese.
- Statin-naïve or with no statin use during the last 4 weeks prior to enrolment except in the event of patients may receive at most 7 doses of statins during current hospitalization before enrollment.
Exclusion Criteria:
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrolment or randomisation in the present study
- Participation in another clinical study with an investigational product or device during the last 30 days excluding prospective/retrospective register based studies that do not require any extra visits in addition to ordinary health care. Patients who withdraw from this study for any reason cannot re-enter the study.
Patients in whom rosuvastatin is contraindicated i.e.
- patients with hypersensitivity to rosuvastatin or any of the excipients.
- patients with active liver disease including unexplained, persistent elevations of serum transaminases and have serum transaminase elevation exceeding 3 x the upper limit of normal (ULN).
- patients with severe renal impairment (creatinine clearance <30 ml/min).
- patients with myopathy.
- patients receiving concomitant cyclosporin.
- females during pregnancy and lactation and women of childbearing potential who are not using appropriate contraceptive measures.
- Significant medical or psychological condition that, in the opinion of the Investigator, would compromise the patient's safety or successful participation in the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Active app
The smart phone application used on the patients' smart phones will contain both the patient support tool and the questions for the clinical evaluation in the form of the Rosuvastatin Adherence questionnaire (RAQ), Beliefs about Medicine Questionnaire - General (BMQ-G), (Horne, 1999) and a Lifestyle questionnaire (LSQ) on disease understanding, lifestyle and treatment awareness.
Patients in the Active group will also receive feedback on their daily rosuvastatin treatment as entered in the patient support tool.
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The smart phone application used on the patients' smart phones will contain both the patient support tool and the questions for the clinical evaluation in the form of the Rosuvastatin Adherence questionnaire (RAQ), Beliefs about Medicine Questionnaire - General (BMQ-G), (Horne, 1999) and a Lifestyle questionnaire (LSQ) on disease understanding, lifestyle and treatment awareness.
Patients in the Active group will also receive feedback on their daily rosuvastatin treatment as entered in the patient support tool.
Otros nombres:
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Otro: Control app
a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ).
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the patients will have no access to the smart phone-based patient support tool.
However, a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Duration of Treatment
Periodo de tiempo: limited to 169 days
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The time from randomization to last patient reported visit (prior to the end-of-study visit) to a doctor to get a prescription for rosuvastatin plus the number of days of medicine provided in that last prescription.
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limited to 169 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Fully Adherent Patients
Periodo de tiempo: Up to 24 weeks
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The number of patients who answered 'Yes' to Q4 of Rosuvastatin Adherence Questionnaire (RAQ) at all time points divided by the total number of randomized patients.
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Up to 24 weeks
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Treatment Adherence
Periodo de tiempo: Up to 24 weeks
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The number of reported rosuvastatin tablets taken divided by the total number of days in the study.
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Up to 24 weeks
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Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline
Periodo de tiempo: Baseline and Week 24
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Low-Density Lipoprotein-Cholesterol (LDL-C) change from baseline at the Week 24 assessment for subjects who completed 24 weeks of treatment
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Baseline and Week 24
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Stefan C Carlsson, AstraZeneca R&D
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de julio de 2015
Finalización primaria (Actual)
28 de octubre de 2016
Finalización del estudio (Actual)
28 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
29 de abril de 2015
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2015
Publicado por primera vez (Estimar)
4 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D3560C00088
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .