Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Rosuvastatin Adherence App Study in China (eHELP China)

31 août 2018 mis à jour par: 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.

Aperçu de l'étude

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

Interventionnel

Inscription (Réel)

885

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Beijing, Chine, 100730
        • Research Site
      • Beijing, Chine, 100034
        • Research Site
      • Beijing, Chine, 100029
        • Research Site
      • Beijing, Chine, 100191
        • Research Site
      • Beijing, Chine, 100049
        • Research Site
      • Beijing, Chine, 100045
        • Research Site
      • Beijing, Chine, 100700
        • Research Site
      • Beijing, Chine, 101199
        • Research Site
      • Changsha, Chine, 410005
        • Research Site
      • Chengdu, Chine, 610041
        • Research Site
      • Chongqing, Chine, 400013
        • Research Site
      • Hang Zhou, Chine, 310003
        • Research Site
      • Huzhou, Chine, 313003
        • Research Site
      • Nanchang, Chine, 330009
        • Research Site
      • Shandong, Chine, 262700
        • Research Site
      • Shanghai, Chine, 200072
        • Research Site
      • Shanghai, Chine, 201199
        • Research Site
      • Shanghai, Chine, 200240
        • Research Site
      • Shanghai, Chine, 200050
        • Research Site
      • Tianjin, Chine, 300142
        • Research Site
      • Tianjin, Chine, 300211
        • Research Site
      • Tianjin, Chine, 300192
        • Research Site
      • Waifang, Chine, 261500
        • Research Site
      • Wenzhou, Chine, 325000
        • Research Site
      • Wuhan, Chine, 430022
        • Research Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
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:
  • Actif
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).
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:
  • Contrôler

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Duration of Treatment
Délai: limited to 169 days
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.
limited to 169 days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Fully Adherent Patients
Délai: Up to 24 weeks
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.
Up to 24 weeks
Treatment Adherence
Délai: Up to 24 weeks
The number of reported rosuvastatin tablets taken divided by the total number of days in the study.
Up to 24 weeks
Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline
Délai: Baseline and Week 24
Low-Density Lipoprotein-Cholesterol (LDL-C) change from baseline at the Week 24 assessment for subjects who completed 24 weeks of treatment
Baseline and Week 24

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Directeur d'études: Stefan C Carlsson, AstraZeneca R&D

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 juillet 2015

Achèvement primaire (Réel)

28 octobre 2016

Achèvement de l'étude (Réel)

28 octobre 2016

Dates d'inscription aux études

Première soumission

29 avril 2015

Première soumission répondant aux critères de contrôle qualité

29 avril 2015

Première publication (Estimation)

4 mai 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 janvier 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 août 2018

Dernière vérification

1 août 2018

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • D3560C00088

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 .

3
S'abonner