Rosuvastatin Adherence App Study in China (eHELP China)
31 augustus 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
885
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Beijing, China, 100730
- Research Site
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Beijing, China, 100034
- Research Site
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Beijing, China, 100029
- Research Site
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Beijing, China, 100191
- Research Site
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Beijing, China, 100049
- Research Site
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Beijing, China, 100045
- Research Site
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Beijing, China, 100700
- Research Site
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Beijing, China, 101199
- Research Site
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Changsha, China, 410005
- Research Site
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Chengdu, China, 610041
- Research Site
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Chongqing, China, 400013
- Research Site
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Hang Zhou, China, 310003
- Research Site
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Huzhou, China, 313003
- Research Site
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Nanchang, China, 330009
- Research Site
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Shandong, China, 262700
- Research Site
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Shanghai, China, 200072
- Research Site
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Shanghai, China, 201199
- Research Site
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Shanghai, China, 200240
- Research Site
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Shanghai, China, 200050
- Research Site
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Tianjin, China, 300142
- Research Site
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Tianjin, China, 300211
- Research Site
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Tianjin, China, 300192
- Research Site
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Waifang, China, 261500
- Research Site
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Wenzhou, China, 325000
- Research Site
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Wuhan, China, 430022
- Research Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 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.
Andere namen:
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Ander: 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).
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Duration of Treatment
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Fully Adherent Patients
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Stefan C Carlsson, AstraZeneca R&D
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
20 juli 2015
Primaire voltooiing (Werkelijk)
28 oktober 2016
Studie voltooiing (Werkelijk)
28 oktober 2016
Studieregistratiedata
Eerst ingediend
29 april 2015
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2015
Eerst geplaatst (Schatting)
4 mei 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 januari 2019
Laatste update ingediend die voldeed aan QC-criteria
31 augustus 2018
Laatst geverifieerd
1 augustus 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D3560C00088
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