- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02433288
Rosuvastatin Adherence App Study in China (eHELP China)
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Beijing, Chine, 100730
- Research Site
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Beijing, Chine, 100034
- Research Site
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Beijing, Chine, 100029
- Research Site
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Beijing, Chine, 100191
- Research Site
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Beijing, Chine, 100049
- Research Site
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Beijing, Chine, 100045
- Research Site
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Beijing, Chine, 100700
- Research Site
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Beijing, Chine, 101199
- Research Site
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Changsha, Chine, 410005
- Research Site
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Chengdu, Chine, 610041
- Research Site
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Chongqing, Chine, 400013
- Research Site
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Hang Zhou, Chine, 310003
- Research Site
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Huzhou, Chine, 313003
- Research Site
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Nanchang, Chine, 330009
- Research Site
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Shandong, Chine, 262700
- Research Site
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Shanghai, Chine, 200072
- Research Site
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Shanghai, Chine, 201199
- Research Site
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Shanghai, Chine, 200240
- Research Site
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Shanghai, Chine, 200050
- Research Site
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Tianjin, Chine, 300142
- Research Site
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Tianjin, Chine, 300211
- Research Site
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Tianjin, Chine, 300192
- Research Site
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Waifang, Chine, 261500
- Research Site
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Wenzhou, Chine, 325000
- Research Site
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Wuhan, Chine, 430022
- Research Site
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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:
- 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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: 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.
|
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.
Autres noms:
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Autre: 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).
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Duration of Treatment
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Fully Adherent Patients
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Stefan C Carlsson, AstraZeneca R&D
Publications et liens utiles
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 (Estimation)
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
- D3560C00088
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