Rosuvastatin Adherence App Study in China (eHELP China)
31 agosto 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
885
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Beijing, Cina, 100730
- Research Site
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Beijing, Cina, 100034
- Research Site
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Beijing, Cina, 100029
- Research Site
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Beijing, Cina, 100191
- Research Site
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Beijing, Cina, 100049
- Research Site
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Beijing, Cina, 100045
- Research Site
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Beijing, Cina, 100700
- Research Site
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Beijing, Cina, 101199
- Research Site
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Changsha, Cina, 410005
- Research Site
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Chengdu, Cina, 610041
- Research Site
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Chongqing, Cina, 400013
- Research Site
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Hang Zhou, Cina, 310003
- Research Site
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Huzhou, Cina, 313003
- Research Site
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Nanchang, Cina, 330009
- Research Site
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Shandong, Cina, 262700
- Research Site
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Shanghai, Cina, 200072
- Research Site
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Shanghai, Cina, 201199
- Research Site
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Shanghai, Cina, 200240
- Research Site
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Shanghai, Cina, 200050
- Research Site
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Tianjin, Cina, 300142
- Research Site
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Tianjin, Cina, 300211
- Research Site
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Tianjin, Cina, 300192
- Research Site
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Waifang, Cina, 261500
- Research Site
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Wenzhou, Cina, 325000
- Research Site
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Wuhan, Cina, 430022
- Research Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: 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.
Altri nomi:
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Altro: 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).
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Duration of Treatment
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Fully Adherent Patients
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Stefan C Carlsson, AstraZeneca R&D
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
20 luglio 2015
Completamento primario (Effettivo)
28 ottobre 2016
Completamento dello studio (Effettivo)
28 ottobre 2016
Date di iscrizione allo studio
Primo inviato
29 aprile 2015
Primo inviato che soddisfa i criteri di controllo qualità
29 aprile 2015
Primo Inserito (Stima)
4 maggio 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
31 gennaio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 agosto 2018
Ultimo verificato
1 agosto 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D3560C00088
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 .